Granules India gets USFDA nod

By Our Corporate Bureau | 24 May 2004

Hyderabad: Granules India''s API and PFI manufacturing facilities at Jeedimetla and its dedicated PFI manufacturing facility at Gagillapur have been audited and approved by the US FDA. The company shortly expects to receive a formal communication in this regard from the FDA.

The company is confident that with the US FDA approvals in place for its facilities, it should be able to step up its exports to the regulated markets and enhance its customer base. The company is already a major exporter to the regulated markets and its products are well received by several International Formulations Companies.

Granules India is a pioneer and the world leader in the manufacture of pharmaceutical formulation intermediates (PFIs) and commissioned one of the largest facilities in the world for manufacturing PFIs at Gagillapur in August 2003.

The facility was audited and approved by the German Health Authority in Jan 2004.