Latest news with #GoodManufacturingPractices
Business Standard
21 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.
Time of India
2 days ago
- Business
- Time of India
Centre extends deadline for revised Schedule M implementation for small, medium pharmas
Mysuru: The Union govt has extended the deadline for implementing the revised Schedule M–Good Manufacturing Practices (GMP)–for small and medium pharmaceutical enterprises (SMEs) with an annual turnover of Rs 250 crore or less, until the end of this year, said Khalid Ahmed Khan, deputy drug controller and president of the Indian Pharmaceutical Association (IPA), Karnataka state branch. He was speaking at the inauguration of a national conference on 'Enhancing Pharmaceutical Quality Assurance through Good Manufacturing Practices (GMP)' and a special session on the Revamped Pharmaceutical Technology Upgradation Assistance Scheme. The event was organised by the PHD Chamber of Commerce and Industry (PHDCCI) health committee in association with the department of pharmaceuticals, Union ministry of chemicals and fertilizers, JSS Academy of Higher Education and Research (JSS AHER) and the IPA Mysuru branch, at the JSS College of Pharmacy on Wednesday. Khan noted that due to the financial burden involved in implementing the revised quality framework, MSME firms were granted time until Dec 2025 to comply. "Firms with turnover above Rs 250 crore, as well as all newly established plants, are required to adopt the revised Schedule M immediately. These guidelines are aligned with WHO and international standards and emphasise total quality management and robust pharmaceutical systems," he added. Khan stressed the importance of leadership and a quality-driven mindset in the pharmaceutical sector. "Even if you're not in a leadership position, you can influence those who are. Without quality, neither the industry nor its workforce can sustain," he said. Dr H Basavana Gowdappa, VC, JSS AHER, commended the department of pharmaceuticals for launching the RPTUAS and urged the industry to treat GMP not as a regulation but a fundamental responsibility. Amaresh Tumbagi, former drug controller of Karnataka, outlined the inspection mechanisms under the revised Schedule M and how regulatory processes have evolved. Dr Pramod Kumar TM, principal, JSS College of Pharmacy, provided insights into current industry regulations and compliance requirements. Jatin Nagpal, joint secretary, PHDCCI, Dharmendra Kumar Yadav, under secretary, department of pharmaceuticals, Yashwant Shinde, manager, SIDBI and Dr Savitha RS, secretary, IPA Mysuru local branch were also present.
Time of India
2 days ago
- Business
- Time of India
With no upgradation plan, several small drug companies may shut operations
New Delhi: Thousands of pharmaceutical companies in the micro, small and medium enterprise (MSME) sector face the grim prospect of closure, having passed the May-end deadline for submitting plans to the government for upgrading their manufacturing facilities. Only a fraction of such units, 1,700 out of an estimated 6,000, have submitted plans for upgradation as per the newly-notified Good Manufacturing Practices ( GMP ), people in the know told ET. Industry executives said they anticipate many units to shut down and thousands of job losses as these units struggle with high costs needed to make the necessary infrastructure improvements. The government, meanwhile, is likely to initiate site audits and kick-off regulatory action against those not complying with the new standards, the people said. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 혈압, 혈당, 고지혈로 고민이 많으신 분들만 읽어주세요. 메디셜 더 읽기 Undo Experts noted that if the government takes stringent action, it may cause drug shortages in areas like cancer, where there are fewer manufacturing units. Live Events "Next few months will see a lot of small sector units getting closed, resulting in increased unemployment. The upgradation requirement to Schedule M has created challenges for small and medium units potentially leading to closures and unemployment," said an industry executive, raising concerns about the future of these units. Some executives believe that 'stop production notices' will be issued to units not complying with the newly-notified standards, which may inflate drug prices. "These units require hand holding by the government and if they do not get further support, then production will stop, resulting in escalation of drug prices," a second executive said. Health ministry officials however stressed that sufficient time has been given to the industry for complying with the new norms. Earlier the ministry had received several representations from pharma associations with annual revenues of less than '250 crore for extension of timeline for the implementation of revised Schedule M. Schedule M of the Drugs and Cosmetics Act outlines quality standards for pharma products. To address their concerns, in February, the ministry issued another notification for extension of implementation of revised Schedule M whereby manufacturers with less than Rs 250 crore revenues were required to file an application to the Central License Approving Authority within three months, along with the plan of upgradation.
Business Upturn
3 days ago
- Business
- Business Upturn
Zydus completes USFDA inspection at oncology plant with two minor observations, none related to data integrity
By Aditya Bhagchandani Published on June 18, 2025, 16:48 IST Zydus Lifesciences Ltd has announced the successful conclusion of a Good Manufacturing Practices (GMP) follow-up inspection by the United States Food and Drug Administration (USFDA) at its oncology injectable manufacturing facility located at SEZ 1, near Matoda, Ahmedabad. The inspection was conducted over a 10-day period, from June 9 to June 18, 2025. In a regulatory filing to the stock exchanges, the company stated, 'We wish to inform that the US Food and Drug Administration (USFDA) conducted a GMP follow-up inspection at the company's oncology injectable site situated at SEZ 1, near Matoda, Ahmedabad.' The company further added that the inspection concluded with two observations, emphasizing that 'none of them were related to data integrity.' Zydus assured stakeholders that it is taking these observations seriously and is committed to addressing them promptly. 'The Company will closely work with the USFDA to address and respond to the observations in an expeditious manner,' the statement read. This update has been provided in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Zydus also requested that this development be 'brought to the notice of the members of the exchange and the investors at large.' The successful closure of the inspection without any data integrity issues is a positive sign for Zydus, reaffirming its compliance with global manufacturing standards in a critical therapeutic segment. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Business Upturn
3 days ago
- Business
- Business Upturn
Glenmark receives five procedural observations from USFDA after Monroe facility inspection
By Aditya Bhagchandani Published on June 18, 2025, 09:04 IST Glenmark Pharmaceuticals on Wednesday announced that the United States Food & Drug Administration (USFDA) has issued a Form 483 with five procedural observations following a recent inspection at its Monroe, North Carolina manufacturing facility. The inspection, conducted between June 9 and June 17, 2025, focused on Good Manufacturing Practices (GMP). According to Glenmark's regulatory filing, all five observations raised by the USFDA were procedural in nature, and importantly, no data integrity issues were identified. The company has assured that it will work closely with the USFDA to address the noted observations and respond within the stipulated timeline. Glenmark emphasized its commitment to maintaining quality standards and regulatory compliance across its global operations. The update was disclosed in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. 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. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
