Latest news with #U.S.FDA
The Hindu
6 hours ago
- Business
- The Hindu
Natco Pharma's Hyderabad API plant receives EIR from U.S. FDA
Generic drugmaker Natco Pharma has received an establishment inspection report from the U.S. Food and Drug Administration for its active pharmaceutical ingredient manufacturing facility in Hyderabad. The U.S. FDA had inspected the API facility, in Mekaguda here, from June 9-13 and issued Form 483 with one observation. The regulator had classified it as 'voluntary action indicated' (VAI), the company said on Thursday, announcing issue of the EIR. Natco Pharma shares closed 3.58% lower at ₹997.70 each on the BSE.
The Hindu
6 days ago
- Business
- The Hindu
Dr. Reddy's formulations facility in AP gets 7 U.S. FDA observations
The U.S. Food and Drug Administration (U.S. FDA) has issued seven observations to Dr. Reddy's Laboratories after an inspection of the generic drugmaker's formulations manufacturing facility in Srikakulam, Andhra Pradesh. 'The U.S. FDA today completed a GMP and a pre-approval inspection (PAI) at our formulations manufacturing facility FTO 11 in Srikakulam, AP. The inspection was conducted from July 10-18. We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline,' Dr. Reddy's said in a filing on Friday.
Business Standard
7 days ago
- Business
- Business Standard
Lupin's arm receives GMP certification from Australia's TGA
Lupin announced that its wholly owned subsidiary, Lupin Manufacturing Solutions (LMS), has received GMP certification from the Therapeutic Goods Administration (TGA), Australia's regulatory authority for medicines and medical devices. The certification applies to LMSs active pharmaceutical ingredient (API) manufacturing facility in Dabhasa, Gujarat. LMS provides pharmaceutical contract development and manufacturing organization (CDMO) services, focusing on the production and supply of APIs. Dr. Abdelaziz Toumi, chief executive officer, Lupin Manufacturing Solutions. We are pleased to have received the GMP certification from TGA for our Dabhasa facility. This reflects the high standard of our manufacturing practices and expertise of our team at Dabhasa, As we continue to expand our global footprint, we remain focused on quality, compliance, and the highest standards of operational integrity, setting new benchmarks in the CDMO space. Meanwhile, the company notify that the U.S. FDA inspected Lupins Pithampur Unit-3 manufacturing facility from July 07 to July 17, 2025. The inspection closed with the issuance of a Form-483 with three observations. We will address the observations and collaborate with the U.S. FDA to resolve them within the stipulated timeframe. We are committed to be compliant with CGMP quality standards across all our facilities. In other regulatory updates, Lupin disclosed that the U.S. Food and Drug Administration (FDA) conducted inspections at its Pithampur manufacturing facilities. The inspection of Pithampur Unit-3 took place from 7 July to 17 July 2025, resulting in a Form-483 with three observations. Similarly, the Pithampur Unit-2 facility was inspected from 8 July to 17 July 2025, with four observations noted in the Form-483. The company confirmed that it is actively addressing all observations and will work closely with the U.S. FDA to resolve them within the stipulated timeframe. Lupin reaffirmed its commitment to maintaining compliance with current Good Manufacturing Practice (CGMP) quality standards across all its manufacturing units. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24. The scrip shed 0.94% to Rs 1,937 on the BSE.
The Hindu
14-07-2025
- Business
- The Hindu
Glenmark gets U.S. FDA warning letter for Indore plant
The U.S. Food and Drug Administration has issued a warning letter to Glenmark Pharmaceuticals for the company's manufacturing facility in Indore, Madhya Pradesh. 'The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility,' Glenmark said in a filing on Saturday. The U.S. FDA had inspected the facility from February 3-14 and issued a Form 483 with five observations. In May, the company said it has received a communication from the regulator indicating the inspection classification as Official Action Indicated (OAI). 'We are committed to addressing the concerns raised... work with the U.S. FDA to resolve the issues at the earliest. There was no observation related to data integrity reported. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards...' Glenmark said.
Time of India
14-07-2025
- Business
- Time of India
Glenmark Pharma shares in focus after USFDA warning to Indore plant
Glenmark Pharmaceuticals shares may be in focus on Monday, July 14, after the company disclosed that it has received a warning letter from the U.S. Food and Drug Administration (FDA) for its facility in Indore, Madhya Pradesh. The inspection at Glenmark's Indore site was conducted between February 3 and February 14, 2025. Following the inspection, the FDA issued a warning letter highlighting concerns related to quality and compliance. 'We wish to inform you that the company has received a warning letter from the U.S. FDA for the company's Indore, Madhya Pradesh (India) facility. The U.S. FDA had inspected Glenmark's Indore site from February 3, 2025 to February 14, 2025,' the company said in an exchange filing. However, Glenmark clarified that the warning letter is not expected to impact existing supplies or revenue from operations at the Indore site. The company stated, 'The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.' Addressing investor concerns, Glenmark emphasized its commitment to resolving the issues raised by the U.S. FDA at the earliest. It also clarified that there were no observations related to data integrity during the inspection. 'We uphold quality and compliance issues with utmost importance and remain committed to being compliant with CGMP quality standards across all our facilities,' the company noted. This update follows Glenmark's earlier intimation on May 9, 2025, regarding the Indore facility receiving Official Action Indicated (OAI) status from the U.S. FDA. On Friday, shares of Glenmark Pharmaceuticals surged 14.5% to close at Rs 2,181.55 on BSE. Also read: Madhuri Kela-backed smallcap stock zooms nearly 100% in 3 months, hits new all-time high ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
