Latest news with #cGMP
Business Standard
17 hours ago
- Business
- Business Standard
Natco Pharma receives seven observations from USFDA Following Inspection at Kothur Facility
Natco Pharma announced that its pharmaceutical manufacturing facility in Kothur, Hyderabad, has received seven observations from the United States Food and Drug Administration (USFDA) following a recent inspection. In a regulatory filing, the company stated that the USFDA conducted the inspection from 9 June to 19 June 2025. At the conclusion of inspection, the USFDA has issued a Form 483 with seven observations. Natco Pharma expressed confidence in addressing the observations within the stipulated timeline and reaffirmed its commitment to current Good Manufacturing Practices (cGMP) and the consistent supply of high-quality pharmaceutical products to global markets. NATCO Pharma, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The companys consolidated net profit increased 5.3% to Rs 406.60 crore on a 14.3% jump in revenue from operations to Rs 1,221 crore in Q4 FY25 over Q4 FY24. The counter shed 0.98% to Rs 872.75 on the BSE.
The Hindu
a day ago
- Business
- The Hindu
U.S. FDA issues 7 observations to Natco Pharma's formulations unit in Hyderabad
The U.S. Food and Drug Administration (U.S. FDA) has issued seven observations to Natco Pharma's formulations facility in Kothur, Hyderabad. The facility was inspected by the U.S. FDA from June 9-19. On conclusion, the company received seven observations in Form-483, Natco Pharma said on Thursday. The company said it is confident of addressing the observations within the stipulated timeline. 'The company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally,' Natco Pharma said. The U.S. FDA had in April 2024 issued a warning letter to the facility while raising quality concerns. The action followed an inspection and issue of eight observations in October 2023 by the regulator. The company then said the move may result in delay or withholding of pending product approvals from the site. The facility is for oral solid dosages, including cytotoxic orals; cytotoxic injectables; and pre filled syringes. The focus product categories are oncology, gastroenterology, central nervous system and cardiology. EOM
The Hindu
6 days ago
- Business
- The Hindu
Sun Pharma's Halol facility issued eight observations by U.S. FDA
Sun Pharmaceutical Industries' drug manufacturing facility in Halol, Gujarat, has been issued eight observations by the U.S. Food and Drug Administration (FDA). The U.S. FDA issued a Form-483 with eight observations following conclusion of a Good Manufacturing Practices (GMP) inspection of the facility from June 2-13, Sun Pharma said in a filing to the stock exchanges on Saturday. 'This is further to our update on Halol dated 16 December 2022,' the company said, referring to the warning letter the U.S. FDA had issued to the facility. The warning letter came close on the heels of regulator placing the Halol facility under import alert. The warning letter had summarised violations with respect to current good manufacturing practice (cGMP) regulations.
Business Upturn
13-06-2025
- Business
- Business Upturn
Syngene International receives EIR from USFDA for Biocon Park facility, inspection concludes with VAI classification
Syngene International Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its GMP manufacturing facilities located at Biocon Park, SEZ, Bengaluru. This follows the routine current Good Manufacturing Practices (cGMP) inspection conducted between February 10 and February 20, 2025. As per the EIR dated June 11, 2025, the inspection has been classified as Voluntary Action Indicated (VAI). The USFDA has reviewed and accepted Syngene's responses along with the Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional observations. Advertisement The company will continue to provide periodic updates to the USFDA on the implementation status of the corrective actions. Syngene reiterates its commitment to maintaining the highest standards of regulatory compliance. This inspection outcome is not expected to have any adverse impact on the Company's financial performance or operations.
Business Upturn
13-06-2025
- Business
- Business Upturn
NATCO Pharma receives one observation after US FDA inspection at Mekaguda API facility
NATCO Pharma Limited has announced the successful conclusion of a routine inspection by the U.S. Food and Drug Administration (US FDA) at its Active Pharmaceutical Ingredients (API) manufacturing facility in Mekaguda, Hyderabad. The inspection was conducted over a five-day period from June 9 to June 13, 2025. Upon conclusion, NATCO received only one observation in the Form 483 issued by the US FDA. According to the company, the observation is procedural in nature, and it is confident in addressing it comprehensively and in a timely manner. In the excahgne filings, the company shared, 'The U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, Hyderabad, India, which was conducted from June 9th – June 13th, 2025. On conclusion of the inspection, the Company received 1 (One) observation in the Form-483. The Company believes that the observation is procedural in nature. The Company is confident to address this observation comprehensively.' NATCO emphasized its ongoing commitment to current Good Manufacturing Practices (cGMP) and assured stakeholders of its continued focus on producing high-quality pharmaceutical products for global markets. Ahmedabad Plane Crash 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
