Topics: USFDA

Jubilant Life Sciences partners with Gilead Sciences to develop remdesivir

India-based drugmaker Jubilant Life Sciences on Tuesday said that "It's subsidiary Jubilant Generics Limited has entered into a non-exclusive agreement with Gilead Sciences to...

Biocon receives two observations from USFDA for API Manufacturing Facility in Bengaluru

India's leading biopharma company, Biocon Limited on Thursday said that “It has received a Form 483 and two observations for its Small Molecules API...

Cipla receives a warning letter from USFDA for its Goa manufacturing unit

The US Food and Drug Administration (USFDA) has issued a warning letter to Cipla's Goa manufacturing facility. In a regulatory filing with Stock Exchange, the...

Biocon receives three observations from USFDA for its Insulin Glargine facility in Malaysia

India's leading biopharma company Biocon on Saturday said that “It has received three observations for its insulin manufacturing facility in Malaysia from the United...

US health regulator seeks voluntary action against Dr Reddy’s Duvvada facility

India's leading pharma company Dr Reddy's Laboratories said that “The US health regulator has asked the company to take voluntary action against its Duvvada...

Dr Reddy's Laboratories launches 'Generic Sodium Nitroprusside injection,' for immediate reduction of blood pressure

India's largest drug maker Dr Reddy's Laboratories has announced the launched of 'Sodium Nitroprusside injection,' in the U.S. market for immediate reduction of blood...

Zydus Cadila launches Insomnia drug for US market

Zydus Cadila, one of the leading pharmaceutical company on Tuesday, announced the launch of its insomnia drug called Ramelteon tablets, in the US market. In...

Zydus Pharma receives USFDA approval to market for Omega 3 Acid Ethyl Esters Capsules

Zydus Pharma on Saturday announced that its US arm Nesher Pharmaceuticals has received final approval from the USFDA to market to market Omega-3-Acid Ethyl...

Caplin Point Labs gets USFDA approval for its new anticholinergic drug

India based mid-cap pharmaceutical company. Caplin Point Laboratories has announced that "One of its subsidiaries received an anticholinergic drug approval from US health regulator." The...

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