Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee
he US FDA has issued six observations pursuant to the completion of the audit.
he US FDA has issued six observations pursuant to the completion of the audit.
The company has responded to the warning letter and carried out the committed corrections.
Strides is the first Indian company to get approval for the product.
The two generic drugs have been launched under the brand names Jankey & Sitenali.
With this acquisition, UBC provides the most comprehensive REMS services and innovative risk mitigation solutions for the biopharmaceutical industry
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022
India exported about Rs 33,321 crore and imported Rs 35,249 crore worth APIs and Bulk drugs in 2021-22.
Tanner will be the supplier of olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available.
Subscribe To Our Newsletter & Stay Updated