Latest news with #Form483
Business Standard
3 days ago
- Business
- Business Standard
Piramal Pharma's Canada facility gets zero USFDA observation
Piramal Pharma announced that the United States Food and Drug Administration (USFDA) has completed a general good manufacturing practices (GMP) inspection at its manufacturing facility in Aurora, Canada. According to a regulatory filing, the inspection was carried out from 26 May 2025 to 30 May 2025. At the conclusion of the inspection, the USFDA issued a zero-observation report in Form 483 and granted a no action indicated (NAI) designation. The company remains dedicated to maintaining the highest standards of compliance. Piramal Pharma (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 17 global 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. The companys consolidated net profit jumped 51.6% to Rs 153.50 crore on 7.9% rise in revenue from operations to Rs 2,754.07 crore in Q4 FY25 over Q4 FY24. Shares of Piramal Pharma rose 0.36% to Rs 207.05 on the BSE.
Business Upturn
3 days ago
- Business
- Business Upturn
Piramal Pharma successfully clears US FDA GMP inspection at Aurora facility
By Aman Shukla Published on June 2, 2025, 10:32 IST Piramal Pharma Limited has successfully completed the US FDA Good Manufacturing Practices (GMP) inspection at its Aurora, Canada facility. The inspection took place from May 26 to May 30, 2025. The US FDA conducted a thorough general GMP inspection, evaluating the facility's compliance with stringent manufacturing standards. Piramal Pharma's Aurora site was awarded a clean slate with zero Form 483 observations and received a No Action Indicated (NAI) designation, underscoring its commitment to excellence and regulatory compliance. This successful inspection reinforces Piramal Pharma's position as a leading pharmaceutical company dedicated to maintaining the highest quality standards in drug manufacturing. The company continuously strives to ensure the safety, efficacy, and quality of its products for patients worldwide. This successful inspection reinforces Piramal Pharma's position as a leading pharmaceutical company dedicated to maintaining the highest quality standards in drug manufacturing. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Upturn
3 days ago
- Business
- Business Upturn
Alembic Pharma shares dip over 2% after USFDA issues 4 observations for Panelav facility
By Aman Shukla Published on June 2, 2025, 10:25 IST Shares of Alembic Pharmaceuticals fell over 2% on Monday following news that the United States Food and Drug Administration (USFDA) issued four observations after inspecting the company's API-I & II facility at Panelav, Gujarat. As of 10:22 AM, the shares were trading 1.88% lower at Rs 998.90. The unannounced, routine cGMP (current Good Manufacturing Practices) inspection was conducted between May 26 and May 31, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 outlining four observations. Importantly, Alembic confirmed that none of the observations relate to data integrity — a key concern for regulators and investors. The company stated that it will submit a comprehensive response to the USFDA within the required timeframe. Management emphasized that the issues raised are 'addressable' and reiterated its commitment to maintaining high standards of quality and regulatory compliance. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Economic Times
3 days ago
- Business
- Economic Times
Stocks in news: Apollo Hospitals, IndiGo, Tata Motors, BPCL, Vodafone Idea
Live Events (You can now subscribe to our (You can now subscribe to our ETMarkets WhatsApp channel Markets began the June expiry on a muted note and ended marginally lower, continuing the ongoing consolidation phase. In today's trade, shares of Apollo Hospitals Vodafone Idea among others will be in focus due to various news developments and fourth quarter CEO Pieter Elbers said that the three-month extension, granted till August 2025, for the 'damp-leased' aircraft from Turkish Airlines by DGCA will help the airline manage ongoing operations and customer Motors reported a decline in overall sales, with total sales down 8.6% year-on-year at 70,187 units in May 2025, compared to 76,766 units last year, while domestic sales dropped 10% to 67,429 sales rose 17% year-on-year to 4.31 lakh units in May, compared to 3.69 lakh units last year, with two-wheeler sales up 16% at 4.16 lakh units versus 3.59 lakh units in the same board has approved an investment in a joint venture with Tikitar and Shell India, aimed at manufacturing and marketing bitumen products. Alembic Pharmaceuticals has received a Form 483 from the US FDA with four observations for its API-I and API-II manufacturing units at India has filed the draft red herring prospectus (DRHP) for its subsidiary Bharat Coking Coal Ltd (BCCL) with Sebi. The proposed IPO will be an offer for sale (OFS) of up to 46.57 crore shares by Coal Reddy's said on Novo Nordisk's Semaglutide patents in India that the matter is currently Hospitals Enterprise reported fourth-quarter profit above market estimates on Friday, driven by higher demand for its healthcare products retailer Nykaa posted a fourth-quarter profit that nearly tripled year on year as premium brands continued to attract urban telco Vodafone Idea reported narrowing of losses for the March quarter to Rs 7,166 crore and its board greenlit fundraising of up to Rs 20,000 crore subject to shareholders' approval and statutory nods.
Business Standard
26-05-2025
- Business
- Business Standard
Dr Reddys Labs' manufacturing facility gets two form 483 observations from US FDA
Dr Reddys Laboratories said that the United States Food & Drug Administration (US FDA), post a GMP inspection, has issued a Form 483 with 2 observations to the company's Telangana-based manufacturing facility. In a regulatory filing made on Saturday (24 May 2025), the company informed that the US FDA had conducted a GMP inspection at its API manufacturing facility in Miryalaguda, Telangana, India. The inspection was conducted from 19 May 2025 to 24 May 2025. Post the inspection, the American regulatory agency has issued a Form 483 with 2 observations. The pharmaceutical company stated that it would address the said observation from the US FDA within the stipulated timeline. Hyderabad-based Dr. Reddys Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. The company reported a consolidated net profit of Rs 1,594 crore for the quarter ended March 2025 (Q4FY25), marking a 22% year-on-year increase from Rs 1,307 crore in the same period last year. Revenue from operations rose 20% year-on-year to Rs 8,506 crore, compared to Rs 7,083 crore in Q4FY24. The scrip rose 0.46% to currently trade at Rs 1235.40 on the BSE.
