Aurobindo Pharma Gets EMA Nod for Biosimilar Facility
By Rediff Money Desk, New Delhi Nov 12, 2024 18:48
Aurobindo Pharma's Hyderabad-based biosimilars facility receives GMP certification from the European Medicines Agency, paving the way for approvals for three biosimilars.
New Delhi, Nov 12 (PTI) Aurobindo Pharma on Tuesday said its unit has received GMP certificate of compliance for its Hyderabad-based biosimilars manufacturing facility from the European Medicines Agency.
CuraTeQ Biologics, a wholly-owned subsidiary of Aurobindo Pharma, has received the certification.
The GMP inspection, conducted by European Medicines Agency (EMA) representatives from April 8th to April 12th, 2024, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and QC testing and release laboratories, the Hyderabad-based drug maker said in a regulatory filing.
"The EU GMP certification marks a significant milestone in CuraTeQ's commitment to manufacturing high-quality biosimilars for patients worldwide," Aurobindo Pharma Director and CEO of Biologics, Vaccines, and Peptides Satakarni Makkapati said.
This inspection outcome paves the way for securing approvals for the company's three biosimilars in Europe, currently under review by the Agency, within the next two to five months, he added.
Aurobindo Pharma shares of Tuesday ended 1.59 per cent down at Rs 1,267.40 apiece on BSE.
CuraTeQ Biologics, a wholly-owned subsidiary of Aurobindo Pharma, has received the certification.
The GMP inspection, conducted by European Medicines Agency (EMA) representatives from April 8th to April 12th, 2024, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and QC testing and release laboratories, the Hyderabad-based drug maker said in a regulatory filing.
"The EU GMP certification marks a significant milestone in CuraTeQ's commitment to manufacturing high-quality biosimilars for patients worldwide," Aurobindo Pharma Director and CEO of Biologics, Vaccines, and Peptides Satakarni Makkapati said.
This inspection outcome paves the way for securing approvals for the company's three biosimilars in Europe, currently under review by the Agency, within the next two to five months, he added.
Aurobindo Pharma shares of Tuesday ended 1.59 per cent down at Rs 1,267.40 apiece on BSE.
Source: PTI
Read More On:
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- Vodafone Idea L
- 6.67 ( -3.61)
- 72559040
- Srestha Finvest
- 0.63 (+ 1.61)
- 31651775
- Suzlon Energy Ltd.
- 65.15 ( -0.47)
- 15879230
- AvanceTechnologies
- 0.93 ( -2.11)
- 12473834
- Thinkink Picturez
- 2.44 ( -20.00)
- 12405311
MORE NEWS
Afcons Infrastructure Q2 Profit Rises 30% to Rs...
Afcons Infrastructure Ltd reported a 30% increase in net profit to Rs 135.43 crore for...
Alembic Gets 5 USFDA Observations for Gujarat...
Alembic Pharmaceuticals received five observations from the USFDA after an inspection...
Sebi Bans 2 Individuals in Jagsonpal Pharma...
Sebi has barred two individuals from the securities markets for one year and imposed a...