Granules Pharmaceuticals received US WA approval

Granules India Ltd, today announced that, the US FDA has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen 650 mg Tablets, Extended Release, bioequivalent to the reference listed drug product (RiD), Tylenol 650mg tablets, Extended Release. The ANDA was filed by Granules Pharmaceuticals Inc, a wholly owned subsidiary of Granules India Limited.

Acetaminophen 650 mg extended release tablets are used primarily for temporary pain management including arthritis relief.

"The addition of Acetaminophen 650mg, extended release tablets to our OTC portfolio leverages several components of our value proposition. Granules' is the only supplier that is backward integrated up to the API on this product. Our vertically integrated approach will enable us to provide a high quality, cost-efficient product that benefit consumers. With a capacity of over 24,000 mt/year of Acetaminophen AM and finished dosage capacity of more than 18 billion units/year, we are confident that we will ensure supply security to our customers which will support us to capture our target market share," said Mr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India.

Shares of GRANULES INDIA LTD. was last trading in BSE at Rs.113.95 as compared to the previous close of Rs. 113.9. The total number of shares traded during the day was 20414 in over 192 trades.

The stock hit an intraday high of Rs. 114.6 and intraday low of 113.25. The net turnover during the day was Rs. 2325094. 
 

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