Latest news with #USFDA
Business Upturn
14 hours ago
- Business
- Business Upturn
Granules India's Bonthapally facility completes US FDA inspection with one observation
By Aditya Bhagchandani Published on June 20, 2025, 16:28 IST Granules India announced on June 20, 2025, that its API Unit-I facility at Bonthapally, located in Sangareddy District near Hyderabad, has successfully completed a US FDA inspection conducted between June 16 and June 20. The inspection concluded with a single Form 483 observation. In an exchange filing, the company stated it would address the observation within the prescribed timeline. Granules emphasized that the Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing units by volume and also houses manufacturing plants for Metformin and Guaifenesin APIs. The company assured investors that the outcome will be managed in line with regulatory expectations. 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.
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.
Hans India
a day ago
- Business
- Hans India
UFlex Introduces FSSAI compliant Single-Pellet Solution for Food Packaging
UFlex, India's largest multinational flexible packaging and solutions company, has announced the launch of its latest innovation, an FSSAI-compliant single-pellet solution for the use of recycled PET in food and beverage packaging. This innovative product integrates recycled PET with virgin PET in a single pellet of high purity and mechanical and thermal stability. The packages produced from this resin are of high clarity, strength, and lower acetaldehyde content. Importantly, this resin solution is compatible with existing PET manufacturing lines enabling a seamless transition to rPET without investing in any new infrastructure. Aligned with the recent FSSAI guidelines that support the Government of India's Extended Producer Responsibility (EPR) framework, UFlex's single-pellet solution on offers a fully compliant, ready-to-implement op on for FMCG companies striving to meet their sustainability commitments. Effective April 1, 2025, the new rules mandate that brands using Category-1 rigid plastic packaging, such as PET bottles, incorporate at least 30% recycled content by FY26. The innovation complies with FSSAI's definition of Food Contact Material-recycled PET (FCM-rPET), which requires a validated decontamination process to ensure the material is safe for direct food contact. UFlex's solution meets both national and international safety standards, including approval from the US Food and Drug Administration (USFDA). Commenting on the launch, Ashish Saxena, Joint President – Packaging Films Business, UFlex Limited, said, 'Since our inception, we have always been committed to pioneering sustainable packaging solutions. We are pleased to offer our latest innovation—the single-pellet solution, which will be a game-changer for food and beverage brands striving to meet EPR compliance under the new FSSAI guidelines. Our recent announcement of ₹317 crore investment in two new recycling plants in Noida is a strong reaffirmation of our commitment to India's plastic waste management vision. As regulations become more robust, we aim to set the benchmark for responsible production and scalable, sustainable packaging solutions in India and beyond.' UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials: recycled polyethylene terephthalate (rPET), recycled polyethylene (rPE), and recycled polypropylene (rPP) for use in food packaging. With a global recycling capacity of 72,300 metric tonnes per annum (MTPA), and an additional 39,600 MTPA set to be commissioned soon, UFlex has established one of the most robust recycling ecosystems in the industry. To date, the company has recycled over 5 billion post-consumer PET bottles, converting them into high-quality raw materials for sustainable packaging solutions. In FY25 alone, UFlex recycled 8,200 metric tonnes of mixed flexible waste, advancing its circular economy goals. It has established recycling plants across India, Poland, Egypt, and Mexico, processing a wide range of post-consumer plastic waste. It is the only Indian company working on innovative solutions for mixed flexible waste and PCR applications both in India and globally. For queries: [email protected]
Time of India
a day ago
- Business
- Time of India
USFDA issues Form 483 with 7 observations to Natco's pharma Hyderabad division
Natco Pharma on Thursday said the US health regulator has issued a Form 483 with seven observations after inspecting its pharma division in Hyderabad. The US Food and Drug Administration (USFDA) had conducted an inspection at the company's pharma division located in Kothur, Hyderabad, from June 9-19, 2025, Natco Pharma said in a regulatory filing. "On conclusion of the inspection, the company received seven observations in the Form-483," it said. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Natco said it is confident that it will address the observations within the stipulated timeline and remains committed to being cGMP compliant and supplying high-quality products to its customers and patients globally.
Mint
2 days 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.
