Biocon gets eight observations for two new units in Bengaluru
Biotechnology major, Biocon, said it has received a total of eight observations from the US health regulator for its two new biologics manufacturing facilities in Bengaluru.
The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) at two of the company’s new biologics manufacturing facilities in Bengaluru from September 10-19, 2019, Biocon said in a filing to the stock exchange. The inspection included a new drug substance and a drug product unit, it added.
“At the conclusion of the inspection, we received a Form 483 with four observations for the new drug substance facility, three observations for the new drug product facility and one general observation,” a Biocon spokesperson said in a statement. The company is confident of addressing these observations effectively through a Corrective and Preventive Action (CAPA) plan, expeditiously, it added.
The company did not provide any details about the observations made by the US regulator.
Looking for chemical products? Let suppliers reach out to you!
You May Interested In
2026-07-19
Trade Alert
Delivering the latest product trends and industry news straight to your inbox.
(We'll never share your email address with a third-party.)
Related News
-
Commercialisation plans for insulin glargine unchanged: Biocon
-
Biocon's Malaysia manufacturing facility receives EU GMP nod
-
Understand the New Rules to Enter the Market | ECHEMI × API China 2026 Overseas Pharmaceutical Market & Product Trends Conference Successfully Concluded
-
72 Hours at API China: Where China’s API Export Industry Is Heading Next
-
ECHEMI WPO and Pharmaceutical Division Showcase Dual Strengths at the 94th API China, Tackling Pharmaceutical Export Challenges with Precision
-
When Global Buyers No Longer Visit Trade Shows but “Select Suppliers with a Click”
-
When Global Buyers Sit at the Same Table, Chinese Suppliers Respond: A Real 1-on-1 Online Business Matching Event
-
CPHI China 2026 Concludes Successfully, ECHEMI Serves Global Pharmaceutical Clients
-
Review of the 93rd API China: In Chongqing, Witnessing the Global Pulse of the Pharmaceutical Industry
-
On the Second Day of the 93rd API China: ECHEMI Advances Global Dialogue in the Pharmaceutical Industry Through Innovative Practices
Recommend Reading
-
From API China to the Global Pharmaceutical Chain: ECHEMI Is Reshaping the "New Speed" of Pharmaceutical Trade
-
ECHEMI and CPHI China Jointly Host Pharmaceutical Business Match-making Event
-
November Maleic Anhydride Prices Generally Decline in China
-
2026 Q1 Chemical Giant Earnings: Supply Contraction, Flat Demand, Full-Scale "Defense Priority"
-
November Refinery Petroleum Coke Market Trends Decline
-
Premium Global Chemical Sourcing Requests (15-19 Dec 2025)
-
Premium Global Chemical Sourcing Requests (04-06May, 2026)