The Hyderabad-based Granules India Ltd has informed that the company's pharmaceutical formulation intermediates (PFIs) facilities at Jeedimetla and Gagillapur were audited by the GMP Audit and Licensing Section of the Therapeutic Goods Administration (TGA) of Australia from November 12, 2004 to November 17, 2004 and found to be compliant.

Official communication to this effect and a certificate from TGA will be received in due course. With this approval the company's facilities now have all the major regulatory approvals including the US FDA and German Health Authority.

These approvals demonstrate the company's strengths in regulatory compliance and it's quality production. These approvals would also facilitate the company to further strengthen its presence in the regulated markets, it said in a release.

Granules is a leading manufacturer of Paracetomol in India. It has the distinction of being one of the largest manufacturers of Directly Compressible Granules and amongst the leading manufacturers of Acetaminophen / Paracetamol, Guaifenesin and Pyrazinamide in the world.