Granules India plant gets 11 observations from Portugal govt
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 will provide its response with a preventive and corrective action plan within the specified time.
In addition, the pharma company said, it will also be requesting the inspection agency to re-inspect the Gagillapur plant at the earliest.
“The company is dedicated to meet all the necessary regulatory requirements and keep in sync with the industry’s best practices,” it said.
Based in Hyderabad, Granules India has eight manufacturing facilities spread across India, China and the US. The company recorded consolidated revenues of Rs.14,312 million in the financial year 2015-16, compared to Rs.12,937 million in the previous year, a gentle growth of 11%.