Drug Approval | January 25, 2023
Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules
Granules now have a total of 53 ANDA approvals from USFDA
Granules now have a total of 53 ANDA approvals from USFDA
The product will be manufactured at the plant of Bell, Sons & Co. (Druggists) Ltd. located at Gifford House, Slaidburn Crescent, Southport, UK
The company is adding new capabilities of Combi-line for Microsphere, additional Bag line and lyos for the Penem block in Pashamylaram facility in Hyderabad and will be earmarking capital for further building on its Biosimilar CDMO facility
The National Institute of Pharmacy and Nutrition, Hungary has issued 'Certificate of GMP Compliance of Manufacturer' for IOL Chemicals and Pharmaceuticals Limited's products.
OrbiMed's exercise of warrant conversion will further strengthen the company's net cash position to over Rs.650 crores.
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies
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