Search result for 'usfda'

Lupin Gets USFDA Nod for Generic HIV Drug

February 3, 2025 15:54

Lupin has received USFDA approval for its generic version of Symtuza, a medication for HIV. The product is estimated to have annual sales of USD 1.374 billion in the US.

Granules India Gets USFDA Nod for ADHD Treatment

January 30, 2025 14:05

Granules India receives USFDA approval for its generic Lisdexamfetamine Dimesylate capsules, indicated for the treatment of ADHD and Binge Eating Disorder in adults and children.

Granules India Q3 Profit Dips 6% to Rs 118 Crore

January 24, 2025 14:54

Granules India's net profit for the third quarter ended December 31, 2024, declined 6% year-on-year to Rs 118 crore. Revenue from operations also decreased. The company's shares were trading down...

Lupin Gets USFDA Nod for Generic HIV Drug

January 24, 2025 14:38

Lupin has received USFDA approval to market a generic HIV medication in the US market, under the PEPFAR program. The drug will be manufactured in Nagpur and supplied to low-and middle-income...

Zydus Usnoflast Gets Orphan Drug Designation for ALS Treatment

January 22, 2025 19:32

Zydus Lifesciences's Usnoflast receives Orphan Drug Designation from the USFDA for the treatment of Amyotrophic Lateral Sclerosis (ALS), a rare neurodegenerative disease.

Strides Pharma Gets USFDA Nod for Generic Pain Relief Drug

January 20, 2025 18:04

Strides Pharma Science's Singapore arm receives USFDA approval for its generic Acetaminophen and Ibuprofen tablets, offering a dual-action pain relief option for a broader patient base.

Alembic Gets USFDA Nod for Generic Antidepressant Tablets

January 15, 2025 15:53

Alembic Pharmaceuticals has received USFDA approval for its generic version of Brexpiprazole tablets, used to treat major depressive disorder. The approval covers strengths ranging from 0.25 mg to...

Lupin Gets USFDA Approval for Generic Cystic Fibrosis Treatment

January 9, 2025 17:38

Lupin receives USFDA approval for its generic version of Ivacaftor oral granules, a treatment for cystic fibrosis. The approval marks a significant step for Lupin in the US market.

Zydus Lifesciences Partners with CVS Caremark for Diabetes Drugs

January 7, 2025 14:01

Zydus Lifesciences has partnered with CVS Caremark to add its diabetes medications, Zituvio, Zituvimet, and Zituvimet XR, to the latter's template formulary. This partnership will improve access to...

Alembic Gets USFDA Nod for Generic Anti-Epileptic Drug

December 20, 2024 16:30

Alembic Pharmaceuticals receives USFDA approval for generic Divalproex Sodium delayed-release capsules, a treatment for epilepsy. The drug is therapeutically equivalent to Depakote Sprinkle capsules.

Zydus Lifesciences Gets USFDA Nod for Lidocaine & Prilocaine Cream

December 19, 2024 13:52

Zydus Lifesciences receives USFDA approval to manufacture generic Lidocaine and Prilocaine cream, a topical anesthetic used for local analgesia and minor surgery.

Indoco Remedies Goa Plant Gets USFDA Warning Letter

December 17, 2024 16:33

Indoco Remedies received a warning letter from the USFDA for its Goa manufacturing plant after failing to meet compliance standards. The company is working to resolve the issues.

Granules India Gets USFDA Nod for Generic ADHD Drug

December 17, 2024 15:50

Granules India's subsidiary receives USFDA approval for generic Lisdexamfetamine Dimesylate chewable tablets, a medication used to treat ADHD and binge eating disorder.

Caplin Point Labs Gets USFDA Nod for Generic Eyedrop - Difluprednate

December 16, 2024 14:07

Caplin Point Labs receives USFDA approval for its generic version of Difluprednate eye drop, indicated for inflammation and pain after ocular surgery. The approval marks a significant milestone...

Aurobindo, Glenmark Recall Products in US Due to Manufacturing Issues

December 15, 2024 13:00

Aurobindo Pharma, Glenmark, and Zydus are recalling products in the US due to manufacturing issues, including impurities above FDA limits. Learn more about the recalls and affected products.

Veerhealth Care: USFDA Assessment Success & Global Expansion

December 13, 2024 20:11

Veerhealth Care successfully completes USFDA assessment, opening doors to the US market. The company is poised for global expansion with significant export orders and strategic partnerships.

Aurobindo Pharma Gets USFDA Approval for Generic Cancer Drug

December 5, 2024 16:30

Aurobindo Pharma's subsidiary, Eugia Pharma Specialities, has received USFDA approval to market Pazopanib Tablets (200 mg) in the US. The drug is therapeutically equivalent to Novartis' Votrient...

Lupin Recalls Hypertension Drug in US: USFDA

November 25, 2024 19:20

Lupin Pharmaceuticals Inc is recalling over 6 lakh bottles of Ramipril capsules in the US due to CGMP deviations. The recall affects bottles manufactured at Lupin's Goa facility.

Alembic Gets 5 USFDA Observations for Gujarat Plant

November 23, 2024 21:02

Alembic Pharmaceuticals received five observations from the USFDA after an inspection of its Gujarat-based manufacturing plant. The company will respond to the observations within the stipulated...

Marksans Pharma Gets USFDA Approval for Generic Allergic Rhinitis Treatment

November 22, 2024 17:30

Marksans Pharma receives USFDA approval for its generic version of Loratadine tablets, a treatment for allergic rhinitis. The approval marks a significant milestone for the company.

Abbott Launches Leadless Pacemaker in India

November 22, 2024 13:33

Abbott introduces AVEIR VR leadless pacemaker in India for patients with slow heart rhythms. The device is FDA-approved and aims to simplify implantation and retrieval processes.

Cipla Recalls Generic Drug in US: Broken Tablets - FDA

November 20, 2024 17:21

Cipla is recalling over 1,800 boxes of Lanthanum Carbonate chewable tablets in the US due to reports of broken tablets. The recall, classified as Class II, affects the medication used for high...

USFDA Issues 7 Observations to Dr Reddy's Bollaram Unit

November 19, 2024 19:08

Dr Reddy's Laboratories received seven observations from the USFDA following an inspection of its Bollaram facility. The company will address the observations within the stipulated timeline.

Dr Reddy's & FDC Recall Products in US for Manufacturing Issues

November 17, 2024 11:25

Dr Reddy's Laboratories and FDC Ltd are recalling generic medications in the US due to manufacturing issues. The recall affects Morphine Sulfate extended-release tablets and Timolol Maleate...

Alembic Pharma Gets USFDA Nod for Generic Hypertension Treatment

November 11, 2024 12:46

Alembic Pharmaceuticals receives USFDA approval for its generic Diltiazem Hydrochloride extended-release capsules, indicated for hypertension treatment. The approval covers various strengths of the...

Dr Reddy's Recalls Cinacalcet Tablets in US: USFDA

November 3, 2024 14:31

Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of Cinacalcet tablets in the US due to manufacturing issues. The recall involves multiple strengths of the medication used to treat high...

Biocon Biologics Bengaluru Unit: USFDA Voluntary Action Indicated

October 30, 2024 17:07

Biocon Biologics' Bengaluru drug substance facility has been classified as voluntary action indicated by the USFDA following a cGMP inspection. The action relates to rh-Insulin (rhI) drug substance...

Alembic Pharma Gets USFDA Nod for Generic Hypertension Treatment

October 21, 2024 13:33

Alembic Pharmaceuticals receives USFDA approval for its generic Diltiazem Hydrochloride extended-release capsules used to treat hypertension, offering a cost-effective alternative to the brand-name...

Granules India Gets USFDA Nod for Generic Depression Drug

October 18, 2024 13:40

Granules India has received USFDA approval to market a generic medication for major depressive disorder, Bupropion Hydrochloride extended-release tablets USP (SR), expanding its presence in the US...

Glenmark Recalls Products in US for Manufacturing Issues

October 13, 2024 12:06

Glenmark Pharmaceuticals is recalling two products in the US, Ryaltris Nasal Spray and Ciclopirox Gel, due to manufacturing defects. The USFDA has classified the recalls as Class II and Class III.

Zydus Lifesciences Gets USFDA Nod for Generic Schizophrenia Drug

October 10, 2024 15:44

Zydus Lifesciences has received USFDA approval to manufacture generic Paliperidone extended-release tablets, used to treat schizophrenia. The tablets will be produced at the company's Ahmedabad...

Dr Reddy's Licenses Gilead's HIV Drug Lenacapavir

October 2, 2024 19:52

Dr Reddy's Laboratories has partnered with Gilead Sciences to manufacture and commercialize the HIV drug Lenacapavir in India and 120 other countries. The drug is indicated for treatment of...

Zydus Lifesciences Gets USFDA Approval for Prostate Cancer Drug

October 2, 2024 16:22

Zydus Lifesciences receives USFDA approval to manufacture Enzalutamide tablets, a generic prostate cancer treatment drug, for the US market. The product will be manufactured at the company's...

Aurobindo Subsidiary Gets USFDA Observations for API Plant

September 30, 2024 16:40

Aurobindo Pharma's subsidiary, Apitoria Pharma, received 10 observations from the USFDA after an inspection of its API facility in Telangana. The observations are procedural in nature and will be...

Zydus Gets USFDA Approval for Generic Prostate Cancer Drug

September 28, 2024 17:49

Zydus Lifesciences receives USFDA approval to manufacture Enzalutamide capsules (40 mg), a generic prostate cancer treatment drug. The drug will be produced at the company's Moraiya, Ahmedabad...

Biocon Gets USFDA Observations for Bengaluru API Facility

September 28, 2024 17:49

Biocon's Bengaluru-based API facility received four observations from the USFDA following an inspection. The company plans to address the observations within the stipulated time.

Lupin Gets USFDA Observations for Pithampur Plant

September 28, 2024 16:06

Lupin receives six observations from the USFDA following an inspection of its Pithampur plant in Madhya Pradesh. The company is addressing the observations and will respond within the stipulated...

Alembic Pharma Gets USFDA Nod for Generic Schizophrenia Drug

September 27, 2024 15:48

Alembic Pharmaceuticals receives USFDA approval for its generic version of Paliperidone extended-release tablets, indicated for treating schizophrenia. The drug is therapeutically equivalent to...

SeQuent Scientific & Viyash Lifesciences Merge to Lead Animal Health Market

September 27, 2024 13:01

SeQuent Scientific and Viyash Lifesciences have announced a merger to become a leading player in the global animal health market, combining their expertise and resources for growth.

Torrent Pharma Gets USFDA Form 483 for Pithampur Plant

September 20, 2024 14:14

Torrent Pharmaceuticals received a Form 483 with one observation from the USFDA after an inspection of its Pithampur manufacturing facility. The observation is procedural in nature and the company...

Strides Pharma Gets USFDA Nod for Generic Fluoxetine Tablets

September 16, 2024 15:36

Strides Pharma Science's subsidiary receives USFDA approval for its generic version of antidepressant Fluoxetine tablets in 60mg strength. The product will be manufactured in Puducherry.

USFDA Cites Manufacturing Lapses at Zydus Lifesciences Plant

September 15, 2024 11:20

The USFDA has issued a warning letter to Zydus Lifesciences for manufacturing lapses at its Jarod plant in Gujarat, citing contamination and inadequate investigations.

Aurobindo Pharma Gets First USFDA Approval for Generic Anaesthesia

September 11, 2024 17:58

Aurobindo Pharma's subsidiary, Eugia Steriles, has received its first product approval from the USFDA for Lidocaine Hydrochloride Injection, a generic anaesthesia medication.

Dr Reddy's gets USFDA EIR for Srikakulam API Plant

September 6, 2024 16:29

Dr Reddy's Laboratories received a Voluntary Action Indicated (VAI) establishment inspection report (EIR) from the USFDA for its API facility in Srikakulam, Andhra Pradesh.

Strides Pharma Gets USFDA Nod for Theophylline Tablets

September 6, 2024 11:19

Strides Pharma Science's arm receives USFDA approval for generic Theophylline extended-release tablets, indicated for managing chronic asthma and other respiratory conditions.

Alembic Pharma Gets USFDA Nod for Generic Albendazole Tablets

September 5, 2024 17:27

Alembic Pharmaceuticals has received USFDA approval for its generic version of Albendazole Tablets, indicated for treating infections caused by worms like Taenia solium and Echinococcus granulosus.

Dr Reddy's, Lupin Recall Products in US Due to Manufacturing Issues

September 4, 2024 16:02

Dr Reddy's Laboratories and Lupin are recalling products in the US due to manufacturing issues, including Ibuprofen tablets and Cefixime for Oral Suspension.

Natco Pharma Invests USD 8 Million in eGenesis for Xenotransplantation

September 4, 2024 15:44

Natco Pharma's Canadian arm invests USD 8 million in eGenesis, a biotech company focused on developing human-compatible organs for transplant. The investment will support research and bring...

Lupin Launches Generic Mirabegron Tablets in US

September 4, 2024 15:05

Lupin has launched a generic version of Mirabegron extended-release tablets for overactive bladder in the US, following USFDA approval. The drug is a generic equivalent of Astellas Pharma's...

Biocon Gets USFDA Approval for Generic Heart Failure Drug

September 1, 2024 19:14

Biocon's subsidiary receives USFDA approval for generic Sacubitril/Valsartan Tablets, a medication used to treat chronic heart failure in adults and children.

Zydus Lifesciences Gets USFDA Nod for Scopolamine Transdermal System

August 30, 2024 16:13

Zydus Lifesciences receives USFDA approval to market Scopolamine transdermal system for nausea and vomiting prevention. This is the fifth ANDA approval for Zydus in the transdermal portfolio.

USFDA Issues Warning Letter to Zydus Lifesciences for Injectables Facility

August 30, 2024 15:27

Zydus Lifesciences receives a warning letter from the USFDA for its injectables manufacturing facility in Jarod, Gujarat, due to violations of manufacturing regulations. The letter does not mention...

Natco Pharma Files Generic Cancer Drug Application with USFDA - Business News

August 29, 2024 17:10

Natco Pharma has submitted an ANDA to the USFDA for a generic version of Novartis' Tabrecta, a cancer drug. The company expects to be eligible for 180 days of marketing exclusivity.

Lupin Launches Generic Cancer Drug in US - Doxorubicin Hydrochloride Liposome Injection

August 29, 2024 16:11

Lupin has launched a generic version of Doxorubicin Hydrochloride Liposome Injection (Doxil) in the US market, treating ovarian cancer, AIDS-related Kaposi's Sarcoma, and multiple myeloma.

Biocon Settles with Janssen for Biosimilar Launch

August 29, 2024 10:19

Biocon Biologics has reached an agreement with Janssen to launch its biosimilar medication for autoimmune diseases in Europe, Canada, and Japan. The settlement clears the way for commercialization...

Zydus Lifesciences Gets USFDA Nod for Generic Parkinson's Drug

August 28, 2024 16:25

Zydus Lifesciences has received USFDA approval for Amantadine extended-release capsules, a generic medication for Parkinson's disease, providing 180 days of exclusivity.

Aurobindo, Glenmark, FDC Recall Drugs in US: USFDA

August 26, 2024 19:01

Aurobindo, Glenmark, and FDC are recalling drugs in the US due to manufacturing issues, according to the USFDA. The recalls include pain relief medication, Indomethacin capsules, and Timolol...

Alembic Pharma Gets USFDA Nod for Scalp Psoriasis Drug

August 26, 2024 17:07

Alembic Pharmaceuticals has received USFDA approval to market a generic medication for treating moderate-to-severe scalp psoriasis. The drug, Betamethasone Valerate Foam, is therapeutically...

USFDA Issues Warning Letter to Eugia Pharma for Manufacturing Lapses

August 25, 2024 13:25

USFDA has issued a warning letter to Eugia Pharma, a subsidiary of Aurobindo Pharma, for manufacturing lapses at its Hyderabad plant, citing data accuracy and process simulation issues.

Indoco Remedies Gets USFDA Nod for Generic Lofexidine Tablets

August 21, 2024 14:27

Indoco Remedies receives USFDA approval to market generic Lofexidine tablets, used for opioid discontinuation treatment, with 180 days of exclusivity.

Granules India Gets USFDA Nod for Generic Glycopyrrolate Oral Solution

August 20, 2024 14:45

Granules India receives USFDA approval for its generic Glycopyrrolate oral solution, indicated for pediatric patients with drooling due to neurological conditions.

Aurobindo Pharma Gets USFDA Warning for Telangana Unit

August 16, 2024 11:29

Aurobindo Pharma's Eugia Pharma Specialities Ltd received a warning letter from the USFDA for its formulations manufacturing unit in Telangana. The company assures no impact on existing US supplies.

Alembic Gets USFDA Approval for Generic Deep Vein Thrombosis Medication

August 13, 2024 16:54

Alembic Pharmaceuticals receives USFDA approval for its generic Dabigatran Etexilate Capsules (110 mg) for deep vein thrombosis and pulmonary embolism prophylaxis.

Dr Reddy's Gets USFDA EIR for Visakhapatnam Units

August 12, 2024 10:22

Dr Reddy's Laboratories has received an Establishment Inspection Report (EIR) from the USFDA for its formulations manufacturing units in Visakhapatnam, classifying the facilities to voluntary...

Alembic Pharma Q1 Net Profit Up 12% to Rs 135 Cr - Business News

August 8, 2024 15:55

Alembic Pharmaceuticals reported a 12% increase in net profit to Rs 135 crore for Q1 FY24. Total income also rose to Rs 1,564 crore. Read more about the company's performance.

Alembic Pharma Gets USFDA Approval for Generic Cancer Drug

August 2, 2024 13:18

Alembic Pharmaceuticals receives USFDA approval to market generic Nelarabine Injection for cancer treatment, expanding its portfolio to 211 ANDA approvals.

Rubicon Research Files Rs 1,085 Cr IPO: Pharma Formulation Firm Aims to Raise Funds

August 1, 2024 12:16

Pharmaceutical formulation company Rubicon Research has filed draft papers with Sebi for a Rs 1,085 crore IPO. The IPO includes a fresh issue of shares and an Offer For Sale by promoter General...

Cipla to Supply US from China Plant in H2 FY24-25

July 28, 2024 11:41

Cipla expects to start supplying the US market from its China facility in the second half of FY 2024-25 after receiving USFDA approval. The company is also working to resolve issues with its...

USFDA Approves Sun Pharma's Alopecia Areata Drug - LEQSELVI

July 26, 2024 10:53

Sun Pharma's LEQSELVI (deuruxolitinib) receives USFDA approval for treating severe alopecia areata in adults. This new drug offers hope for patients with this autoimmune disorder causing hair loss.

Zydus Lifesciences Gets USFDA Nod for Diabetes Drug - Zituvimet XR

July 19, 2024 12:16

Zydus Lifesciences receives USFDA approval for its new drug application for Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets, a diabetes medication. This marks the...

USFDA Classifies Zydus Plant as 'Official Action Indicated'

July 18, 2024 18:44

USFDA has issued an 'Official Action Indicated' classification for Zydus Lifesciences's injectables plant in Gujarat, indicating potential regulatory action.

USFDA Classifies Zydus Lifesciences Jarod Unit 'OAI' - What It Means

July 18, 2024 17:55

USFDA classifies Zydus Lifesciences' Jarod injectables facility as 'Official Action Indicated' following inspection. Learn about the implications and what it means for the company.

Glenmark Gets USFDA Approval for Generic Seizure Drug

July 18, 2024 14:21

Glenmark Pharmaceuticals receives USFDA approval to market generic Topiramate Capsules, a medication used for treating and preventing seizures. The drug will be distributed in the US by Glenmark...

Glenmark Pharma Gets USFDA Approval for Seizure Drug

July 17, 2024 09:47

Glenmark Pharmaceuticals has received USFDA approval for its generic Topiramate capsules used to treat seizures. The drug is bioequivalent to Topamax capsules.

Alembic Gets USFDA Nod for Generic Selexipag Injection

July 15, 2024 13:32

Alembic Pharmaceuticals receives tentative USFDA approval for its generic Selexipag injection, a treatment for pulmonary arterial hypertension. The company may be eligible for 180 days of generic...

Lupin Gets USFDA Approval for Generic Seizure Medication

July 12, 2024 17:31

Lupin has received USFDA approval to market a generic version of Topiramate extended-release capsules for the treatment of seizures in patients aged 6 and older.

Zydus Lifesciences Gets USFDA Approval for Heart Failure Drug

July 10, 2024 15:50

Zydus Lifesciences receives USFDA approval to market Sacubitril and Valsartan tablets for chronic heart failure treatment in adults.

Alembic Pharma Gets USFDA Nod for Generic Bromfenac Ophthalmic Solution

July 9, 2024 14:13

Alembic Pharmaceuticals receives USFDA approval for its generic Bromfenac ophthalmic solution, indicated for post-cataract surgery inflammation and pain treatment.

Dr Reddy's, Sun Pharma Recall Drugs in US: USFDA

July 4, 2024 17:34

Dr Reddy's and Sun Pharma are recalling drugs in the US due to manufacturing issues, as per the USFDA. The recalls include insomnia, gout, and chemotherapy medications. Learn more about the...

Zydus Lifesciences Gets USFDA Approval for BP Drug

July 4, 2024 15:02

Zydus Lifesciences receives tentative USFDA approval to market generic Azilsartan Medoxomil tablets for treating high blood pressure.

Alembic Pharma Gets USFDA Approval for Ivosidenib Tablets

July 4, 2024 15:00

Alembic Pharmaceuticals receives tentative USFDA approval for its generic Ivosidenib tablets, a treatment for certain types of cancer of bone marrow and bile duct. The drug is therapeutically...

USFDA Issues Warning Letter to Sun Pharma for Manufacturing Issues

July 3, 2024 18:40

USFDA issued a warning letter to Sun Pharma for failing to adequately clean and maintain equipment at its Dadra facility, citing violations of Current Good Manufacturing Practice (CGMP)...

Biocon Biologics Gets EMA Nod for Bevacizumab Production

June 24, 2024 11:24

Biocon Biologics receives approval from the EMA to manufacture biosimilar Bevacizumab at its Bengaluru facility, expanding capacity for European markets. The company also received GMP certificates...

Lupin, Eugia Recall Products from US Market: USFDA

June 23, 2024 11:22

Lupin and Eugia, a unit of Aurobindo Pharma, are recalling products from the US market due to manufacturing issues. The USFDA has initiated Class II and Class III recalls for various medications....

Biocon Gets 4 USFDA Observations for Andhra Facility

June 22, 2024 18:48

Biocon received four observations from the USFDA after an inspection of its API facility in Visakhapatnam, Andhra Pradesh. The company will address the observations within the stipulated time.

Sun Pharma gets USFDA warning letter for Dadra unit

June 19, 2024 22:00

Sun Pharma has received a warning letter from the USFDA for its Dadra facility due to violations of manufacturing norms. The USFDA's warning letter outlines violations of Current Good Manufacturing...

Alembic Pharma gets USFDA nod for Dabigatran Etexilate capsules

June 18, 2024 16:02

Alembic Pharmaceuticals receives USFDA approval for generic Dabigatran Etexilate capsules 75 mg & 150 mg, used for stroke and blood clot prevention in adults with atrial fibrillation. The company...

Alembic Pharma Gets USFDA Approval for Hereditary Angioedema Injection

June 17, 2024 13:29

Alembic Pharmaceuticals receives USFDA approval for its generic Icatibant injection, a treatment for acute attacks of hereditary angioedema (HAE) in adults. This is the company's first peptide...

Zydus Lifesciences Gets USFDA Nod for Blood Pressure Drug

June 14, 2024 13:55

Zydus Lifesciences receives USFDA approval to market Azilsartan Medoxomil and Chlorthalidone tablets for high blood pressure treatment.

USFDA Issues Form 483 to Torrent Pharma - 5 Observations

June 12, 2024 22:25

Torrent Pharmaceuticals received a Form 483 with five observations from the USFDA after an inspection of its Gujarat manufacturing plant. The company will respond to the observations within the...

Glenmark Gets USFDA Approval for Generic Nexium

June 12, 2024 10:57

Glenmark receives USFDA approval to market generic Esomeprazole Magnesium delayed-release capsules, a generic version of Nexium. This approval will allow the company to enter the market for...

Lupin Launches Generic Drugs in US: USFDA Approval

June 3, 2024 17:11

Lupin has received USFDA approval to launch generic Doxycycline for Injection and Letermovir Tablets in the US market, targeting a combined annual market value of USD 362 million.

Sun Pharma, Dr Reddy's Recall Drugs in US: USFDA

May 30, 2024 17:45

Sun Pharma and Dr Reddy's Laboratories are recalling medications in the US market due to manufacturing issues, according to the USFDA. Learn more about the affected products and recall details.

Alembic Pharma Gets USFDA Nod for Heart Failure Drug

May 30, 2024 16:20

Alembic Pharmaceuticals receives USFDA approval to market a generic medication for heart failure, a therapeutically equivalent version of Novartis's Entresto tablets.

Jubilant Pharmova Q4 Profit Surges to Rs 61 Crore

May 29, 2024 17:03

Jubilant Pharmova's Q4 net profit jumps over 2x to Rs 61 crore, driven by strong performance in international markets. Total income from operations reached Rs 1,773 crore.

Zydus Lifesciences Gets USFDA Nod for Asthma Medication

May 22, 2024 17:31

Zydus Lifesciences has received USFDA approval to market Theophylline extended-release tablets for asthma and COPD. The drug will be manufactured in Ahmedabad SEZ.

Strides Pharma Gets USFDA Nod for Generic Gastrointestinal Drug

May 22, 2024 15:19

Strides Pharma Science's unit receives USFDA approval to market a generic version of Sucralfate Oral Suspension, a medication used to treat gastrointestinal diseases.

Zydus Lifesciences Gets USFDA Nod for Asthma Drug

May 22, 2024 15:09

Zydus Lifesciences receives USFDA approval for its generic Theophylline extended-release tablets for treating asthma and COPD. The drug will be manufactured in Ahmedabad.

Cipla Gets USFDA Nod for Generic Lanreotide Injection

May 22, 2024 12:13

Cipla receives USFDA approval to market generic Lanreotide injection, a treatment for acromegaly and other conditions. The drug is a therapeutic equivalent to Somatuline Depot Injection.

Biocon Biologics Gets USFDA Approval for Biosimilar Ophthalmology Drug

May 21, 2024 11:06

Biocon Biologics has received USFDA approval for Yesafili, a biosimilar to Eylea (aflibercept), for treating various ophthalmology conditions like age-related macular degeneration.

Dr Reddy's, Sun Pharma, Aurobindo Recall Products in US

May 19, 2024 11:13

Dr Reddy's, Sun Pharma, and Aurobindo Pharma are recalling products in the US market due to manufacturing issues, according to the latest USFDA Enforcement Report. The recalls include medications...

Glenmark Gets USFDA Approval for Generic Ophthalmic Solution

May 17, 2024 09:49

Glenmark Pharmaceuticals receives USFDA approval for its generic brimonidine tartrate and timolol maleate ophthalmic solution for treating increased eye pressure caused by glaucoma.

Zydus Lifesciences Gets USFDA Approval for Generic Arthritis Drug

May 11, 2024 16:27

Zydus Lifesciences receives USFDA approval to market Dexamethasone tablets (1mg) for arthritis, blood disorders, and other conditions in the US.

Zydus Lifesciences Gets USFDA Nod for Acne Treatment Gel

May 9, 2024 13:01

Zydus Lifesciences has received USFDA approval to market its generic version of Dapsone gel, a treatment for acne. The gel will be manufactured in Ahmedabad.

Cipla Receives USFDA Form 483 for Kurkumbh Unit

May 8, 2024 15:38

Cipla Ltd received a Form 483 from the USFDA for its Kurkumbh facility in Maharashtra, citing one inspectional observation. The company is committed to addressing the observation.

Gland Pharma Gets USFDA Approval for Generic Edaravone Injection

May 7, 2024 12:56

Gland Pharma receives USFDA approval for its generic Edaravone injection, used to treat amyotrophic lateral sclerosis (ALS). The company expects to launch the product through its marketing partner...

Cipla, Glenmark Recall Drugs from US Market: USFDA

May 5, 2024 10:45

Cipla and Glenmark are recalling drugs from the US market due to manufacturing issues, according to the USFDA. Learn more about the recalled products and reasons behind the recall.

Dr Reddy's Launches Generic Anti-Bacterial Drug in US

May 3, 2024 16:11

Dr Reddy's Laboratories has launched a generic Doxycycline Capsules (40 mg) in the US market, a therapeutic equivalent of Oracea capsules (40 mg).

Maiva Pharma Raises Rs 1,000 Cr from PE Funds

May 2, 2024 17:09

Maiva Pharma secures Rs 1,000 crore funding from Morgan Stanley Private Equity Asia and India Life Sciences Fund to expand its injectables manufacturing capabilities.

Granules India Gets USFDA Approval for Generic Gout Medication

April 30, 2024 11:31

Granules India receives USFDA approval to market Colchicine Capsules (0.6 mg) for gout prevention and treatment. The generic medication is therapeutically equivalent to Hikma International...

Glenmark Pharma Gets USFDA Nod for Generic Anti-Inflammatory Drug

April 29, 2024 10:39

Glenmark Pharmaceuticals receives USFDA approval to sell generic Acetaminophen and Ibuprofen tablets, a version of Advil 2 Dual Action. The company's product is expected to achieve significant...

Lupin Gets USFDA Approval for Generic Eye Treatment Drug

April 25, 2024 19:55

Lupin receives USFDA approval to market Etabonate Ophthalmic Suspension, a generic treatment for seasonal allergic conjunctivitis. The drug is a generic equivalent of Bausch & Lomb's Lotemax.

Zydus Lifesciences Gets USFDA Observations - PTI

April 24, 2024 12:16

Zydus Lifesciences receives 10 observations from the USFDA following an inspection of its injectable manufacturing facility in Gujarat. The company will work to address the observations.

Lupin Launches Generic Mirabegron in US

April 22, 2024 12:01

Lupin launches generic Mirabegron extended-release tablets (25 mg) in the US market, approved by USFDA. The drug treats overactive bladder.

Zydus Lifesciences Launches Generic Overactive Bladder Drug in US

April 22, 2024 11:30

Zydus Lifesciences has launched a generic medication for overactive bladder in the US market. The drug, Mirabegron, is expected to increase access and availability for patients.

USFDA Warns Natco Pharma for Manufacturing Lapses

April 21, 2024 10:45

USFDA issued a warning letter to Natco Pharma for violations at its Telangana plant, citing cleanliness, sterilization, and contamination concerns. The regulator has asked for a comprehensive...

USFDA Issues Form 483 to Marksans Pharma Goa Unit

April 18, 2024 11:08

Marksans Pharma Ltd received five inspectional observations in Form 483 from the USFDA after an inspection of its Goa manufacturing facility. The company will address the observations within the...

Jubilant Pharma Gets USFDA VAI Classification for Roorkee Unit

April 17, 2024 17:07

Jubilant Pharma's Roorkee unit receives a Voluntary Action Indicated (VAI) classification from the USFDA, indicating acceptable compliance with cGMP.

Strides Pharma Gets USFDA Approval for Antidepressant

April 9, 2024 11:12

Strides Pharma Science's subsidiary receives USFDA approval to market generic antidepressant medication Fluoxetine Tabs. The product is therapeutically equivalent to Eli Lilly's Prozac tablets.

Natco Pharma Gets USFDA Warning Letter for Telangana Plant

April 9, 2024 10:51

Natco Pharma received a warning letter from the USFDA for its Telangana plant due to violations found during an inspection. The company assures minimal impact on supplies and revenues but...

Gland Pharma Gets USFDA Approval for Generic Breast Cancer Drug

April 8, 2024 16:47

Gland Pharma receives USFDA approval for Eribulin Mesylate Injection, a generic breast cancer drug, expected to be the first in the market. The company plans to launch the product soon.

Lupin Gets USFDA Nod for Generic Tardive Dyskinesia Drug

April 8, 2024 16:01

Lupin has received USFDA approval to market a generic medication for tardive dyskinesia, a movement disorder. The drug, Valbenazine Capsules, is a generic equivalent of Ingrezza Capsules and is...

Piramal Group Invests Rs 110 cr in Biodeal Pharma

April 8, 2024 12:21

Piramal Group invests Rs 110 crore in Biodeal Pharmaceuticals, a leading manufacturer of nasal sprays, for infrastructure and capacity expansion.

Indian Robotics: Rise of AI Automation Solutions

April 7, 2024 11:00

Indian robotic companies are gaining popularity as enterprises seek customized AI-based automation solutions for logistics, warehousing, and retail. Learn about the growth and future of this sector.

Aurobindo Pharma Unit Gets USFDA Observations

April 5, 2024 18:26

Aurobindo Pharma's subsidiary, Eugia Steriles, received three observations from the USFDA after an inspection of their new injectable facility in Andhra Pradesh.

Strides Pharma Gets USFDA Nod for Generic Gabapentin

March 5, 2024 18:31

Strides Pharma Science's Singapore unit receives USFDA approval to market Gabapentin Tablets USP, 600mg and 800mg, for treating partial seizures and neuropathic pain.

Orchid Pharma Gets USFDA Approval for UTI Drug

February 23, 2024 16:22

Orchid Pharma has received USFDA approval for Enmetazobactam, a new drug to treat complicated urinary tract infections. This marks a significant development in addressing global antimicrobial...

Zydus Lifesciences Gets USFDA Approval for Generic Heart Drug

February 16, 2024 14:40

Zydus Lifesciences has received USFDA approval to manufacture and market its generic Isosorbide Mononitrate extended-release tablets for chest pain prevention in heart patients.

Lupin Gets USFDA Approval for Pregnancy Prevention Drug

February 16, 2024 14:02

Lupin Ltd. receives USFDA approval to market its generic 'Minzoya' tablets for pregnancy prevention. The drug is a generic equivalent of Balcoltra, with estimated annual sales of USD 42 million in...

Lupin Launches Ganirelix Acetate Injection in US - Fertility Treatment

February 15, 2024 14:06

Lupin launches Ganirelix Acetate injection in the US, a generic for fertility treatments, approved by the USFDA. The injection inhibits premature LH surges during controlled ovarian hyperstimulation.

USFDA Grants VAI to Dr Reddy's R&D Center - Hyderabad

February 12, 2024 16:24

Dr Reddy's Laboratories' Hyderabad R&D center receives VAI classification from USFDA following inspection. The classification indicates no immediate regulatory action.

Lupin Gets USFDA Nod for Generic Eye Medication

February 6, 2024 19:59

Lupin receives USFDA approval to market a generic medication for swelling and pain in the eye, a generic equivalent of Sun Pharma's BromSite Ophthalmic Solution.

Biocon Gets USFDA Nod for Generic Anti-Cancer Drug

February 6, 2024 19:54

Biocon Ltd receives USFDA approval for Dasatinib tablets, a generic anti-cancer medication, strengthening its portfolio of complex drug products.

Cipla Targets US Acquisitions, Inorganic Partnerships

February 4, 2024 10:45

Cipla is eyeing acquisitions and inorganic partnerships in the US market while consolidating its presence in India and expanding margins in South Africa. The company is also focusing on resolving...

Strides Pharma Gets USFDA Nod for Generic Pregabalin

January 25, 2024 20:20

Strides Pharma Science subsidiary receives USFDA approval for generic Pregabalin capsules, a medication for nerve pain. The product is bio-equivalent to Lyrica capsules and has a market size of USD...

Zydus Lifesciences Gets USFDA Approval for Generic Gabapentin

January 25, 2024 15:34

Zydus Lifesciences receives USFDA approval to market generic Gabapentin tablets for postherpetic neuralgia, marking the first company to receive final approval for this strength.

Glenmark Licenses Cancer Drug Envafolimab for Asia & More

January 25, 2024 10:54

Glenmark Pharmaceuticals has secured licensing rights for Envafolimab, a cancer drug, in India, Asia Pacific, and other regions. The drug, developed by Jiangsu Alphamab and 3D Medicines, is a PD-L1...

Lupin Gets USFDA Approval for Generic Hyperuricemia Drug

January 18, 2024 17:37

Lupin receives USFDA approval to market generic Febuxostat tablets for the treatment of hyperuricemia in adults with gout. The drug, a generic equivalent of Uloric, will be manufactured in India.

Lupin Gets USFDA Approval for Generic Hypertension Drug

January 14, 2024 16:14

Lupin receives USFDA approval to market generic hypertension drug Propranolol Hydrochloride extended-release capsules in the US, a generic version of ANI Pharmaceuticals' Inderal LA.

India Flags US Visa Delays at TPF Meeting

January 13, 2024 10:55

India raised concerns about visa delays for Indian businesses at the Trade Policy Forum (TPF) meeting, urging the US to expedite the process.

India, US Discuss Trade & Investment Boost at TPF Meet

January 12, 2024 20:43

India and the US discussed ways to enhance trade and investment ties during the 14th Trade Policy Forum (TPF) meeting in New Delhi, focusing on key issues like social security pact, market access...

India-US Trade Talks: Social Security Pact, Mango Access Key

January 11, 2024 19:34

India seeks a social security pact with the US, greater market access for mangoes, and faster USFDA inspections for pharma during the Trade Policy Forum (TPF) meeting in Delhi.

India Demands Faster USFDA Inspections at Trade Forum

January 10, 2024 18:49

India will push for expedited USFDA inspections, removal of shrimp export ban, and GSP reinstatement at the Trade Policy Forum (TPF) meeting on Friday. The meeting will address key trade issues...

Lupin Launches Generic Smoking Cessation Drug in US

January 10, 2024 15:45

Lupin has launched a generic version of Varenicline tablets, used for smoking cessation treatment, in the US market, after receiving approval from the USFDA. The product is the generic equivalent...

Qure.ai's AI X-ray for Lung Nodules Gets USFDA Clearance

January 10, 2024 10:32

Qure.ai's AI-powered chest X-ray solution for lung nodule detection receives USFDA clearance, marking the company's 6th clearance for chest X-ray solutions.

Lupin Launches Generic Postoperative Inflammation Drug in US

January 9, 2024 18:52

Lupin launches generic Bromfenac Ophthalmic Solution in the US, offering a cost-effective treatment for postoperative inflammation after cataract surgery.

Dr Reddy's Recalls Generic Drug in US Due to Packaging Error

January 7, 2024 10:27

Dr Reddy's Laboratories recalls over 8,000 bottles of Tacrolimus capsules in the US due to a packaging error, leading to the presence of foreign tablets/capsules in affected lots.

Lupin Gets USFDA Approval for Generic Diabetes Drug

January 4, 2024 19:17

Lupin receives USFDA approval to market a generic version of AstraZeneca's Qtern tablets, a medication for type 2 diabetes. The drug will be manufactured at Lupin's Pithampur facility.

Lupin Gets USFDA Approval for Generic Diabetes Drug

January 4, 2024 19:12

Lupin has received USFDA approval to market a generic medication for type 2 diabetes, a generic equivalent of AstraZeneca's Qtern tablets. The drug will be manufactured at Lupin's Pithampur facility.

Lupin Gets USFDA Approval for Generic Loteprednol Etabonate

December 27, 2023 16:35

Lupin has received USFDA approval for its generic Loteprednol Etabonate ophthalmic suspension, a treatment for seasonal allergic conjunctivitis. The product is a generic equivalent to Alrex...

Aurobindo Pharma Gets USFDA Approval for Generic Antifungal Injection

December 27, 2023 15:11

Aurobindo Pharma has received USFDA approval to manufacture and market generic Posaconazole injection, used to prevent serious fungal infections. The injection will be launched in December 2023.

Zydus Lifesciences Gets USFDA Observations for API Plant

December 22, 2023 17:09

Zydus Lifesciences received six observations from the USFDA after an inspection of its API plant in Ahmedabad. The inspection closed with no data integrity issues or repeat observations.

Sun Pharma, Lupin Recall Drugs in US Due to Manufacturing Issues

December 17, 2023 10:30

Sun Pharma and Lupin are recalling drugs in the US market due to manufacturing issues. The USFDA has issued a Class II recall for Liothyronine Sodium Tablets and penicillamine tablets.

Zydus Lifesciences Gets USFDA Nod for Generic Anti-Epileptic Drug

December 16, 2023 16:02

Zydus Lifesciences has received USFDA approval to market Lacosamide Tablets, a generic anti-epileptic medication, in multiple strengths. The drug will be manufactured at the group's facility in...

Zydus Gets USFDA Approval for HIV Antiviral Drug

December 15, 2023 15:49

Zydus Lifesciences has received USFDA approval to market a generic antiviral medication for HIV-1 infection, Darunavir Tablets. The drug is indicated for adults and children over 3 years old and...

Gujarat: India's Pharma Hub with 4,000+ Units

December 15, 2023 12:00

Gujarat boasts over 4,000 pharma manufacturing units, contributing significantly to India's pharma production and exports. Learn more about its dominance in the sector.

Zydus Lifesciences Gets USFDA Approval for Generic Cancer Treatment

December 14, 2023 15:34

Zydus Lifesciences receives USFDA approval for its generic version of Cyclophosphamide capsules, a chemotherapy drug used to treat various cancers. The drug will be manufactured in Ahmedabad, India.

India Business News: Rupee Hits All-Time Low, Gold Falls - Dec 13

December 13, 2023 21:36

Get the latest business news from India including rupee's all-time low against the US dollar, gold price drop, and stock market updates. Read about IndiGo's new Ayodhya flight and more.

Granules India Gets USFDA Approval for Generic Pantoprazole

December 13, 2023 13:06

Granules India receives USFDA approval for generic pantoprazole sodium delayed-release tablets for treating erosive esophagitis associated with GERD.

India-Oman Free Trade Agreement: USD 3.7 bn Boost for Indian Goods

December 12, 2023 16:04

India and Oman are negotiating a free trade agreement that could significantly boost Indian goods exports worth USD 3.7 billion, including gasoline, iron & steel, electronics & machinery.

India-Oman FTA: USD 3.7 Billion Trade Boost - GTRI Report

December 12, 2023 11:51

India and Oman are negotiating a free trade agreement that could significantly boost Indian exports to Oman, particularly in gasoline, iron and steel, electronics, and machinery.

USFDA Issues Form 483 to Torrent Pharma Gujarat Unit

December 12, 2023 11:40

USFDA issued Form 483 with 5 procedural observations to Torrent Pharma's Gujarat oral manufacturing facility. The observations were not related to data integrity.

Dr Reddy's Stock Drops 5% After USFDA Observations

December 11, 2023 17:30

Dr Reddy's Laboratories stock closed 5% lower after the USFDA issued three observations for its Hyderabad research facility. The company said it will address the issues within the stipulated timeline.

USFDA Cites Intas Pharma for Manufacturing Lapses

December 10, 2023 10:50

The USFDA issued a warning letter to Intas Pharmaceuticals for manufacturing violations, including CGMP violations, at its Ahmedabad plant. The agency found that the company failed to maintain...

USFDA Inspects Dr Reddy's Hyderabad R'D Facility

December 7, 2023 15:06

Dr Reddy's Laboratories confirms USFDA inspection of its Hyderabad R'D facility. The outcome of the inspection will be disclosed to stock exchanges.

Zydus Lifesciences Gets USFDA Approval for Generic Methylene Blue Injection

December 6, 2023 16:56

Zydus Lifesciences has received USFDA approval to market a generic version of ProvayBlue injection, a treatment for acquired methemoglobinemia. The company's vial presentation offers a...

Lupin Gets USFDA Approval for Generic Smoking Cessation Tablets

December 6, 2023 10:55

Lupin receives USFDA approval for its generic Varenicline tablets, a smoking cessation treatment. This approval marks a significant step for the company, with the product expected to be...

Zydus Lifesciences Gets USFDA Nod for Generic Heart Failure Drug

December 1, 2023 14:50

Zydus Lifesciences receives USFDA approval for its generic version of Ivabradine tablets, indicated for the treatment of heart failure. The drug will be manufactured in Ahmedabad, India.

Aurobindo Gets USFDA Nod for Generic Asthma Medication

November 30, 2023 14:54

Aurobindo Pharma's subsidiary receives USFDA approval to market a generic asthma medication, Budesonide Inhalation Suspension, for children aged 12 months to 8 years. The product is expected to...

Aurobindo Pharma Gets USFDA Approval for HIV Drug

November 29, 2023 12:54

Aurobindo Pharma receives USFDA approval to market a generic HIV-1 treatment drug, Darunavir tablets, in strengths of 600 mg and 800 mg. The drug is therapeutically equivalent to Prezista tablets.

Lupin Gets USFDA Approval for Generic Pulmonary Hypertension Drug

November 2, 2023 14:19

Lupin receives USFDA approval to market generic Selexipag for injection, a treatment for pulmonary arterial hypertension. The drug will be manufactured at the company's Nagpur facility.

Company Name
Price
Volume

Vodafone Idea L
9.47 (+ 2.05)
61048233

Thinkink Picturez
0.45 ( 0.00)
22664084

G G Engineering
1.22 ( -3.94)
18109205

Srestha Finvest
0.69 ( -1.43)
12131937

Hathway Cable & Data
14.75 ( -2.12)
11583833

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