Latest news with #GoodManufacturingPractice
Mint
a day ago
- Business
- Mint
HDFC Mutual Fund raises stake in Glenmark Pharmaceuticals to 5.07%. Details here
HDFC Mutual Fund has increased its stake in Glenmark Pharmaceuticals, breaching the 5 percent ownership threshold, as per the company's regulatory filing on June 18, 2025. The move comes even as Glenmark disclosed recent regulatory scrutiny of its U.S. manufacturing facility by the United States Food and Drug Administration (USFDA). According to the filing, HDFC Mutual Fund purchased an additional 3.57 lakh equity shares of Glenmark Pharma, raising its holding by 0.13 percent. Prior to the transaction, the fund house held 1.39 crore shares, or 4.94 percent of the company. Post acquisition, its total shareholding stands at 1.43 crore shares, which translates to a 5.07 percent stake in the pharmaceutical major. The stake increase is seen as a mark of confidence in the company's fundamentals and long-term growth potential, especially amid recent regulatory developments. As per the March 2025 shareholding pattern, Glenmark's promoters continue to hold a dominant 46.65 percent stake in the company. In parallel with the stake hike, Glenmark Pharmaceuticals also updated the stock exchanges about a recent Good Manufacturing Practice (GMP) inspection conducted by the USFDA at its Monroe, North Carolina facility in the U.S. The inspection, which spanned from June 9 to June 17, 2025, culminated in the issuance of a Form 483 with five observations. The company was quick to clarify that the observations were procedural in nature and did not pertain to data integrity—an issue that often raises red flags in the pharmaceutical industry. In its exchange communication, Glenmark stated, 'The Company will work in close collaboration with the agency to address the observations and will respond to the USFDA within the stipulated timeline.' A Form 483 is typically issued when the FDA investigator identifies possible violations of the Food, Drug, and Cosmetic (FD&C) Act, but the absence of critical concerns such as data falsification is considered a relatively positive outcome. On the market front, Glenmark Pharma shares saw some volatility, falling by as much as 1.5 percent to touch a low of ₹ 1,634.55 on June 18. The stock is still around 11 percent below its 52-week high of ₹ 1,830.05, which it had touched in October 2025. However, it remains significantly above its 52-week low of ₹ 1,199.95, seen in June 2024. The recent price trajectory shows renewed investor interest, with the stock gaining 12.5 percent in June so far, following a 5.5 percent rise in May. This follows a choppy start to the year where the stock fell over 10 percent in April, surged 20.5 percent in March, and posted losses of 12 percent and 9.7 percent in February and January respectively. Disclaimer: The views and recommendations made above are those of individual analysts or broking companies, and not of Mint. We advise investors to check with certified experts before making any investment decisions.
Time Business News
2 days ago
- Business
- Time Business News
Positioning Qatari Products for Global Markets with GMP Standards
Qatar is actively diversifying its economy and expanding its global trade reach. As a result, the need for internationally recognized quality standards is rising. Good Manufacturing Practice (GMP) certification plays a crucial role in ensuring product safety, quality, and regulatory compliance across key industries such as pharmaceuticals, food, cosmetics, and supplements. According to the Ministry of Public Health (MoPH), Qatar's pharmaceutical market is expected to grow to QAR 3.5 billion by 2027. This growth makes alignment with global standards like GMP more important than ever. By adopting GMP standards, Qatari businesses can meet international requirements, improve credibility, and access high-value markets like the GCC, Europe, and Asia. Whether in Doha, Al Rayyan, or Mesaieed, firms that meet GMP expectations are positioned as reliable suppliers. GMP ensures that products are consistently produced and controlled according to quality standards. It covers raw materials, factory conditions, hygiene, and staff training—reducing risks like contamination, recalls, and shipment rejections. Globally, over 50% of product recalls in regulated sectors are due to GMP violations. In 2022, the U.S. FDA issued more than 200 warning letters for non-compliance. These facts highlight the serious consequences of neglecting GMP. Importers, particularly in the EU and U.S., often require GMP certification. Without it, even quality products from Qatar may be denied entry. Hence, GMP is more than compliance—it's a strategic asset. Achieving GMP certification involves facility audits, process improvements, documentation, and staff training. For many companies, especially SMEs, navigating these steps alone is challenging. This is where GMP consultancy in Qatar becomes essential. Experienced consultants identify gaps, advise on improvements, and guide businesses through the compliance process. At Qdot, we've found that over 60% of new clients lack proper SOPs or internal audit procedures—common causes of inspection failures. Qdot is a trusted ISO and GMP consultancy based in Qatar. We work with businesses in Doha, Al Wakrah, Al Khor, and beyond, helping them achieve and maintain GMP compliance. Our services include: GAP analysis and audit preparation SOP and documentation development Staff training programs Post-certification support We tailor our approach to meet each client's needs—from small food startups to large pharma companies. Today's global buyers demand proof of quality. For Qatari firms, GMP certification offers that proof—ensuring products are safe, consistent, and export-ready. As a GMP consultant, I've seen businesses transform through certification. Companies once struggling with basic compliance are now exporting confidently to Europe and Asia. GMP is not just a checklist—it's a long-term investment in quality. With Qdot's support, GMP certification becomes achievable and impactful. Now is the time to partner with expert GMP consultancy in Qatar and elevate your business to global standards. TIME BUSINESS NEWS
Newsroom
2 days ago
- Business
- Newsroom
Cosmetic brands expect sales boom as China drops animal testing requirement
A new certification scheme enabling local cosmetic producers to sell their products in bricks and mortar stores without testing them on animals is a progression the industry has been 'crying out for'. On Wednesday in Shanghai Prime Minister Christopher Luxon announced a new certification scheme for cosmetic producers that will provide exporters with a government-issued Good Manufacturing Practice certificate that meets Chinese regulatory requirements. Certified Kiwi cosmetic brands will be able to sell in physical stores, without having to abide by a long-running legal requirement for foreign-made products to be tested on animals.
Fibre2Fashion
2 days ago
- Business
- Fibre2Fashion
BASF opens new GMP Solution Center in Michigan
BASF opens its new Good Manufacturing Practice (GMP) Solution Center, in Wyandotte, Michigan. This investment underscores the ongoing commitment of BASF to providing innovative solutions in the biopharma and pharmaceutical ingredients industries, including the reliable supply of bioprocessing ingredients and excipients for biopharma applications as well as small molecules. This new facility will play a crucial role in the expansion of BASF's existing network of GMP sites, with innovative systems and processes that ensure products are produced consistently and controlled according to high quality standards. These practices are crucial in the pharmaceutical industry, where the quality of products is paramount for safety and efficacy. Featuring state-of-the-art clean room packaging, and high-sensitivity analytical testing, this new facility enables close collaboration with customers on customized chemistries for product development. Additionally, improved manufacturing capabilities will allow for more tightly controlled parameters beyond compendial limits and a validated control system that allows for high reproductivity. Marion Kuhn, vice president of business management, BASF Pharma Solutions states, 'Our new GMP Solution Center exemplifies BASF's dedication to understanding and addressing the evolving needs of our customers in both the biopharma and pharmaceutical industries. This state-of-the-art facility will play a fundamental role in enabling us to collaborate closely with our customers worldwide on product development and GMP manufacturing in ways that are unique to the industry, further strengthening our position as an innovator in the pharmaceutical sector.' 'Wyandotte's new GMP Solution Center is a key example of BASF's commitment to innovative excellence,' said Benjamin Knudsen, vice president of research North America at BASF Corporation. 'This expansion not only showcases our dedication to developing customized solutions, but it also highlights our ability to adapt and innovate in response to our customers' needs. Together, we are paving the way for new innovative solutions.' Note: The headline, insights, and image of this press release may have been refined by the Fibre2Fashion staff; the rest of the content remains unchanged. BASF has opened a new GMP Solution Center in Wyandotte, Michigan, enhancing its support for the biopharma and pharmaceutical industries. The facility features clean room packaging, advanced testing, and custom chemistry development. It strengthens BASF's global GMP network and commitment to high-quality, innovative solutions and close customer collaboration. Fibre2Fashion News Desk (HU)
The Hindu
2 days ago
- Health
- The Hindu
Conference on pharmaceutical quality assurance through good manufacturing practices held in Mysuru
A national conference on 'Enhancing Pharmaceutical Quality Assurance through Good Manufacturing Practices' was conducted by the JSS Academy of Higher Education and Research in Mysuru on Wednesday. It was held in association with the Indian Pharmaceutical Association, Mysuru branch, along with other organisations, and included a session on Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS). A release said that the initiative aimed to ensure consistent production and control of medicinal products to meet the highest quality standards. The primary objective of the conference was to promote the understanding and implementation of Good Manufacturing Practice (GMP) principles among pharmaceutical manufacturers, emphasising the importance of adherence to GMP standards for ensuring the safety, efficacy, and quality of medicinal products, the release added. The conference also aimed to provide guidance on incorporating GMP requirements into national medicine laws and regulations, while facilitating the exchange of best practices in GMP implementation. The conference was inaugurated by Dr. Khalid Ahmed Khan, Deputy Drug Controller and president of the Indian Pharmaceutical Association (IPA), Karnataka State branch. Dr. H. Basavana Gowdappa, the vice chancellor of JSS Academy of Higher Education & Research, Mysuru, urged the industry to view GMP not merely as a regulatory requirement, but as a core responsibility. Dr. Amaresh Tumbagi, former Drug Controller of the Karnataka government, highlighted various inspections conducted under Schedule M and discussed how regulatory bodies have evolved with the revised version. Dr. Pramod Kumar T.M., Principal, JSS College of Pharmacy, Mysuru, provided insights into industry and government regulations related to GMP. Around 100 delegates from different industries and academics were present apart from the members of IPA Mysuru branch. Dharmendra Kumar Yadav, Under Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, Yashwant Shinde, Manager, Small Industries Development Bank of India (SIDBI), and Dr. R.S. Savitha, Secretary, IPA Mysuru, were among those present.
