Compliance Management / Small Molecule

FDA Refuses Imports from Indian API Maker

Oct 21, 2015

RAPS

The U.S. FDA banned Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, from sending products to the United States, according to RAPS.

Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the U.S. market (as well as the EU market), including for drugs treating Alzheimer's, depression, schizophrenia, multiple sclerosis and overactive bladders, the article said.

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