Drug Approval | January 12, 2023
USFDA inspects Piramal Pharma Lexington facility
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Chyawanprash Special will be available at all Jan Aushadhi Kendras
A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940
None of the observations are related to data integrity and management believes that they are addressable
The product is backed by required scientific proof and comparative bioequivalence studies
EC grants conditional marketing authorization based on the EFFISAYIL trial
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The company hopes to build on this momentum in the coming quarters and continue to focus on our key brands to drive sustainable profitable growth
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
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