Piramal Pharma’s Ahmedabad facility inspection by US FDA closes with zero observations

The US drug regulator conducted a pre-approval inspection of Piramal Pharma’s PPDS Ahmedabad facility for three days, from July 10, 2024, to July 12, 2024.  The United States Food and Drug Administration (USFDA) inspection was completed with zero Form 483 observations and no action-indicated designation.  Tanya Sanish, Company Secretary, informed the exchange that the successful completion of the US FDA inspection at the PPDS Ahmedabad facility will now allow our customers access to our high-end analytical capabilities for their clinical and commercial batches from an FDA-approved site.  Piramal Pharma Limited has achieved a significant milestone, highlighting its commitment to maintaining high-quality standards in its manufacturing processes. A successful pre-approval inspection, with no observations, indicates the facility’s adherence to FDA regulations and guidelines, a promising indicator for the approval of upcoming drug applications. Furthermore, it underscores the company’s dedication to upholding a top-notch management system and producing safe, effective pharmaceuticals. In conclusion, this outcome exemplifies Piramal Pharma Limited’s robust focus on quality and regulatory compliance.

PPL’s global presence & business:

Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries.  PPL includes Piramal Pharma Solutions (PPS), an integrated contract development and manufacturing organization; Piramal Critical Care (PCC), a complex hospital generics business; and the India Consumer Healthcare business, selling over-the-counter products. Additionally, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited, is a joint venture with AbbVie Inc. and has emerged as a market leader in the ophthalmology therapy area. Moreover, PPL has a minority investment in Japan.

PPL’s stock price and profit: 

Piramal Pharma Ltd. stock is right now trading at Rs. 154 per share, which is 2% up after this positive news for the stock on July 12, 2024. Today stock traded high at 158, and market experts are seeking the Rs. 170-180 per share price very soon. In Q4 FY24, the pharmaceutical company experienced a significant surge in net profit, reaching Rs 101.27 crore, a 102.1% increase compared to the Rs 50.11 crore posted in Q4 FY23. This quarter, PPL’s revenue from operations rose by 17.97% YoY to Rs 2,552.36 crore, thanks to the vigorous growth in our CDMO and ICH sectors.

Conclusion: This US FDA inspection with zero observations will boost the company’s confidence and show that they are maintaining high standards for their firm.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.