Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr
The facility was inspected by the regulator between July 15 - July 19, and July 22 - July 26, post which, the observations were issued along with the form-483.
India's Biocon posts Q1 profit rise on sale of branded formulations business
Biocon`s Generics Lenalidomide Receives Tentative Approval in US
Biocon Foundation with IISc lead expert for phase 1 of the project the AI-Center of Excellence
The U.S. Food and Drug Administration (FDA) conducted a combined cGMP inspection and Pre-Licensing Inspection (PLI) at Biocon Biologics’ facilities at Biocon Park, Bengaluru, India between July 15, and July 26, 2024.
NEW DELHI: Biotechnology player Biocon on Saturday said the US health regulator has issued four observations after inspecting its manufacturing plant in Andhra Pradesh. The US Food and Drug Administration (USFDA) concluded a GMP inspection of the company's API facility (Site 5), located at Visakhapatnam, Andhra Pradesh, on June 21, 2024, the company said in a regulatory filing. nnRead more at: nhttps://economictimes.indiatimes.com/industry/healthcare/biotech/biocon-gets-4-observations-from-usfda-for-andhra-pradesh-facility/articleshow/111192847.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
Biocon seeks partner to test generic Wegovy, Ozempic in China
Biocon Ltd on Friday said it has signed an exclusive licensing and supply agreement with South Korea's Handok for commercialisation of its complex drug product, synthetic Liraglutide, used in the treatment of chronic weight management. Under the agreement Biocon will undertake the development, manufacturing and supply of the drug product, and Handok, a specialty pharmaceutical firm, will be responsible for obtaining regulatory approval and commercialisation in the South Korean market, the company said in a statement.
US FDA approves two biosimilars for blockbuster eye drug Eylea