US drug regulator inspects Sun Pharmaceutical's Halol plant in Gujarat

Sun Pharma had recalled around 5,000 units of 10 ml vials of testosterone cypionate injections from the US

Sohini Das  |  Mumbai 

Sun Pharmaceutical Industries’ Halol plant in Gujarat, which was cleared in June by the US drug regulator, has been undergoing a fresh inspection, sources claimed. The company declined to comment on the matter.

Analysts said that while it could be a surprise audit (given the plant’s history of regulatory issues), it could also be a pre-approval inspection (that usually happens before a product from that site is approved by the US drug regulator). Sources claimed a team of inspectors from the US Food and Drug Administration (USFDA) was at the facility to inspect the ...

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First Published: Tue, August 28 2018. 05:30 IST