Search result for 'us fda'

Renalyx Health Systems plans to invest Rs 800 crore in 3 dialysis machine manufacturing units, boosting India's healthcare sector. The company's AI-enabled RxT 21 machine targets wider access to...

Emcure Pharmaceuticals received two observations from the USFDA after an inspection of its Pune-based API manufacturing facility. The company is addressing the observations and will respond to the...

Natco Pharma has received US FDA approval for its generic version of Everolimus tablets for oral suspension, indicated for patients with tuberous sclerosis complex. The drug is a generic version of...

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...

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

Glenmark Pharmaceuticals forecasts a 9-10% CAGR for India's domestic formulations market over the next decade, driven by the growth of Jan Aushadhi outlets. The company expects Trade Generics and...

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.

Veerhealth Care expands its manufacturing capacity with a new land acquisition in Gujarat, aiming to meet growing demand from the US, East & North African markets for oral care products.

Veerhealth Care aims to reach Rs 100 crore revenue in the next 2-3 years, driven by significant export orders and expansion plans. The company has secured multiple export orders from top US...

Sun Pharma has partnered with Takeda to bring Vonoprazan, a novel gastrointestinal drug, to the Indian market. This partnership aims to provide patients with a new treatment option for reflux...

India's food safety regulator has asked Everest Spices to take corrective actions after some samples were found non-compliant with ethylene oxide (EtO) standards. MDH samples were compliant.

Indian shrimp exporters follow strict regulatory and safety standards, aiming for Rs 1 lakh crore seafood exports in the next two years. The industry debunks reports of poor conditions.

India and the US have agreed to increase engagement to address issues impacting medical devices trade, including pricing and standards. The two countries also discussed pharmaceutical supply chain...

Sun Pharma shares rallied over 2.5% on Wednesday after the company reported a 5% increase in consolidated net profit for the September quarter, driven by strong sales in India and the US.

Sun Pharma's consolidated net profit rose 5% to Rs 2,375 crore in Q2 FY24, driven by strong sales in India and the US. The company also highlighted key milestones in its drug development pipeline.