Latest news with #FD&C)Act
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.
Time of India
17-05-2025
- Business
- Time of India
Dr Reddy's NY API plant gets USFDA Form 483 with 2 observations
Dr. Reddy's- building HYDERABAD: Pharma major Dr Reddy's Laboratories on Saturday said its active pharmaceutical ingredients manufacturing facility at Middleburgh in New York has been issued a Form 483 with two observations by the US drug regulator, US Food and Drug Administration (US FDA). 'We have been issued a Form 483 with two observations, which we will address within the stipulated timeline,' Dr Reddy's said in a regulatory filing . The Hyderabad-based company said the good manufacturing practices (GMP) inspection was conducted by US FDA between May 12, 2025, and May 16, 2025, the company said. A Form 483 is issued by USFDA inspectors to the management of the company at the end of an onsite inspection if inspectors find any violations of the Food, Drug and Cosmetic (FD&C) Act or other regulations, as per USFDA. Stay informed with the latest business news, updates on bank holidays and public holidays . AI Masterclass for Students. Upskill Young Ones Today!– Join Now
