US FDA approves Granules facilities

Hyderabad, May 14 (UNI) Granules India Limited, a fully-integrated pharmaceutical company with specialisation in Pharmaceutical Formulation Intermediates (PFI), today announced the approval of its facilities in the recently-conducted audit by the United States Food and Drug Administration (US FDA).

The PFI facility at Gagillapur was re-audited by the FDA and approved following the filing of an Abbreviated New Drug Application by one of the Granules' customers in the United States.

Granules (India) Managing Director Krishna Prasad said in a statement, ''This approval of our Acetaminophen facility by the FDA will help us get into high value combination products of Acetaminophen at the formulations level.

It would also give assurance to our customers that the company adopted highest standards of quality management, he added.

UNI