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.
Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies
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
The yoga protocol included gentle and restorative yoga postures(asana) with regular periods of relaxation and pranayama
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients
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
Investment in R&D was Rs. 337.6 crore (8.3% of sales) for Q2 FY2023 as compared to Rs. 330 crore (8.2% of sales) for Q2 FY2022.
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