Latest news with #Form483
The Hindu
7 hours ago
- Business
- The Hindu
Granules unit in Hyderabad, one of the largest globally for paracetamol API, under U.S. FDA scanner
Generic drugmaker Granules India's active pharmaceutical ingredients (API) manufacturing facility in Bonthapally, Hyderabad, has been issued an observation by the U.S. Food and Drug Administration (U.S. FDA). The Bonthapally facility is one of the world's largest single-site paracetamol API manufacturing plants by volume. Along with paracetamol APIs, the company has established Metformin and Guaifenesin API manufacturing plants in the same facility, Granules India said in an intimation to the stock exchanges on Friday. The U.S. FDA had inspected the facility, located in Sangareddy district, from June 16-20 and issued Form 483 with one observation. The company said it will respond to the observation within the stipulated time.
Business Standard
15 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.
Mint
20 hours ago
- Business
- Mint
Stocks to watch: Nestle, HDFC Bank, HCL Tech, CONCOR among shares in focus today
FMCG giant Nestle India has scheduled a board meeting on June 26 to review and approve a proposal for issuing bonus shares. Global asset management firm TPG is expected to divest 12.5 million shares, amounting to a 6% stake in Sai Life Sciences, in a deal estimated to be worth around $102 million (approximately ₹ 885 crore). The non-banking subsidiary of HDFC Bank has finalized the dates for its highly awaited ₹ 12,500 crore IPO, which is scheduled to open from June 25 to June 27. According to reports, Kaynes Technology has launched its qualified institutional placement (QIP) offering to raise up to ₹ 1,600 crore. The technology giant, a subsidiary of the Larsen & Toubro Group, introduced BlueVerse — a unified AI platform designed to accelerate AI transformation for businesses. CONCOR, the state-owned logistics company, has announced July 4, 2025, as the record date for its 1:4 bonus share issue, offering a potential long-term benefit for retail investors. Goldman Sachs offloaded more than 1.77 lakh shares of Ethos through a block deal valued at ₹ 48 crore, with the shares being sold at a price of ₹ 2,700.6 each. The US FDA issued a Form 483 containing seven observations for the company's pharmaceutical division located in Kothur, Hyderabad. The infrastructure company has officially entered into a $67.25 million ( ₹ 562 crore) agreement with the Government of Guyana for Phase 2 of the East Bank–East Coast Road Linkage Project. The technology solutions company has entered into a strategic Memorandum of Understanding (MoU) with Aldoria, a European leader in Space Surveillance and Situational Awareness (SSA), to enhance India's rapidly growing space capabilities. Disclaimer: This story is for educational purposes only. The views and recommendations above are those of individual analysts or broking companies, not Mint. We advise investors to check with certified experts before making any investment decisions.
Economic Times
21 hours ago
- Business
- Economic Times
Stocks in news: Oswal Pumps, Nestle India, Angel One, Natco Pharma, Ethos
Devender Kumar resigned as the Chief Revenue Officer-Direct Business of the company with effect from September 30. Markets remained mostly flat on the weekly expiry day amidst mixed signals. Several companies saw significant activity, including Oswal Pumps debuting on the exchanges and Nestle India considering a bonus share issue. Block deals impacted Ethos, while Sai Life Sciences may see a stake sale. Natco Pharma received a US FDA Form 483. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Markets traded lacklustre on the weekly expiry day and ended almost flat amid mixed cues. In today's trade, shares of Oswal Pumps Ethos among others will be in focus due to various news of Oswal Pumps will be in focus as the company will debut on the exchanges major Nestle India will hold a board meeting on June 26 to consider and approve a proposal for issue of bonus shares. Goldman Sachs sold over 1.77 lakh shares of Ethos via a block deal. The deal size is worth Rs 48 crore and the shares were sold at a price of Rs assets management company TPG is likely to sell 12.5 million shares representing 6% stake Sai Life Sciences at an estimated deal size of $102 million (Rs 885 crore).GMM Pfaudler arm Pfaudler Normag Systems GmbH, Germany, bagged an order worth Rs 330 crore from a European-based Technology opened its qualified institutional placement (QIP) issue to raise up to Rs 1,600 crore, according to FDA issued Form 483 with 7 observations for company's Kothur, Hyderabad-based Pharma Tech signed a strategic partnership with Europe's Aldoria to strengthen India's Space CapabilitiesDevender Kumar resigned as the Chief Revenue Officer-Direct Business of the company with effect from September 30.
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.
