Search Result for : Granules India

The Dollar Business Bureau  Indian pharma manufacturer Granules India said on Friday that it has got 11 observations from INFARMED - the health authority of Portugal, for its manufacturing unit situated at Gagillapur in the state of Telangana.  “INFARMED had conducted a renewal inspection of the facility. In this respect, the company has received the inspection report with 11 observations,” said Granules India in a regulatory filing.   INFARMED is a Government agency of Portugal accountable to the Health Ministry that evaluates, regulates, authorises, and controls health products as well as human medicines. The Gagillapur plant of the company manufactures finished dosages and pharmaceutical formulation intermediates (PFIs).  The Indian drug maker said that it has started taking necessary steps for addressing the observations of the Portuguese inspection agency and ...

The Dollar Business Bureau Granules India Ltd. on Monday announced that its Jeedimetla plant in Telangana has got an establishment inspection report (EIR) from the US health regulator, United States Food and Drug Administration (USFDA). "The company has received the Establishment Inspection Report from United States Food and Drug Administration for the inspection conducted at its Jeedimetla facility in December 2015," Granules said in a statement. Earlier, the USFDA had acknowledged receipts of responses that the company sent on January 7 and March 28 this year on the observations issued by the FDA for the facility. Acting on those responses, the USFDA had closed the matter and announced the EIR for the Jeedimetla facility. On Monday, the shares of Jeedimetla were trading at around ...

The Dollar Business Bureau    Granules USA, the wholly owned subsidiary of Granules India Ltd., on Thursday announced that it has signed agreement with Par Pharmaceutical Inc., a subsidiary of Endo International Plc., to market the generic version of omeprazole and sodium bicarbonate in North America. The company expects the US Food and Drug Administration (USFDA) approval for this generic heart burn drug in July 2016. Omeprazole is a proton pump inhibitor (PPI) that decreases the production of stomach acid. Sodium bicarbonate is an antacid that raises stomach pH to keep the Omeprazole from breaking down in stomach acid. “Granules is excited that, through this exclusive agreement with Par Pharmaceuticals, we can strengthen our OTC (over the counter) product basket and ...