US FDA issues Form 483 to Lupin’s Goa plant
The company has received seven observations from the US health regulator
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US FDA
US FDA authorises third dose of Pfizer COVID-19 vaccine for older Americans
The booster dose is to be administered at least six months after completion of the second dose, and the authorisation would…
FDA and EMA launch pilot programme to provide scientific advice on complex generic/hybrid products
The pilot programme is an expansion of FDA and EMA’s existing PSA for new drugs and biological products
Granules India and Jubilant Cadista recall products in US market
Granules initiated the Class-II voluntary recall on 11th August this year, while Jubilant commenced the Class-III recall on 21st…
Zydus Cadila receives final approval from US FDA for Mesalamine Extended-Release capsules
The capsules are indicated for the maintenance of remission of ulcerative colitis in adults
Syngene expands biopharma-manufacturing capacity
The company sets up a state-of-the-art microbial facility; expands mammalian facility
Philip Morris International acquires OtiTopic
This acquisition is part of PMI's strategic plan to leverage its expertise, scientific know-how and capabilities in inhalation to…
US FDA approves Nexviazyme for late-onset Pompe disease
The approval is based on the positive phase-III data demonstrating improvements in key disease burden measures and establishing…
Alkem Laboratories launches Ibuprofen, Famotidine tablets in US
The company has launched the tablets in the strength of 800 mg/26.6 mg in the United States, following an approval from the US…
Alkem Laboratories says US FDA inspection at Taloja facility ends with ‘zero’…
At the end of the inspection, no form 483 was issued, the company said