Dr Reddys Labs' manufacturing facility gets two form 483 observations from US FDA
Dr Reddys Laboratories said that the United States Food & Drug Administration (US FDA), post a GMP inspection, has issued a Form 483 with 2 observations to the company's Telangana-based manufacturing facility.
In a regulatory filing made on Saturday (24 May 2025), the company informed that the US FDA had conducted a GMP inspection at its API manufacturing facility in Miryalaguda, Telangana, India. The inspection was conducted from 19 May 2025 to 24 May 2025.
Post the inspection, the American regulatory agency has issued a Form 483 with 2 observations.
The pharmaceutical company stated that it would address the said observation from the US FDA within the stipulated timeline.
Hyderabad-based Dr. Reddys Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.
The company reported a consolidated net profit of Rs 1,594 crore for the quarter ended March 2025 (Q4FY25), marking a 22% year-on-year increase from Rs 1,307 crore in the same period last year. Revenue from operations rose 20% year-on-year to Rs 8,506 crore, compared to Rs 7,083 crore in Q4FY24.
The scrip rose 0.46% to currently trade at Rs 1235.40 on the BSE.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
&w=3840&q=100)
Business Standard
23 minutes ago
- Business Standard
Microfinance: Indicators show cautious lending, continuing stress in parts
Amid these shifts, CRIF High Mark emphasised that the sector remains on a path of long-term sustainability BS Reporter New Delhi The microfinance business continues to prioritise larger loan sizes. According to CRIF High Mark's 'MicroLend March 2025', loans between Rs 30,000–50,000 declined by 6.7 per cent quarter-on-quarter (QoQ), while those up to Rs 30,000 contracted by 8 per cent. Loans in the Rs 50,000-80,000 range saw a moderate QoQ decline of 0.4 per cent. Despite a small base, loans of Rs 80,000, particularly those over Rs 100,000 grew beyond industry trends, indicating a shift toward higher-ticket loans, likely among existing customers. Amid these shifts, CRIF High Mark emphasised that the sector remains on a path of long-term sustainability. While current indicators suggest cautious lending and persistent stress in parts of the portfolio, improvement in early-stage performance and a gradual move towards higher-quality credit segments are encouraging trends.
Hindustan Times
25 minutes ago
- Hindustan Times
Gujarat diamond trader donates jewellery worth crores to Ayodhya Ram Temple
A Gujarat diamond merchant has donated a lavish assortment of ornaments, including 11 crowns and a golden bow and arrow, to the Shri Ram Janmabhoomi Teerth Kshetra Trust in Ayodhya. According to Vishva Hindu Parishad (VHP) officials, the contribution includes 11 diamond-studded crowns, 30 kilograms of silver, 300 grams of gold, and rubies, along with a host of other ornate items. Dinesh Newadia, national treasurer of the VHP, revealed that the donation also features necklaces, earrings, ornamental forehead tilaks, seven bows (four large, three small) representing the brothers of the Ramayana, four quivers, three maces, and ceremonial fly whisks. "Mukesh Patel has donated 11 crowns made of diamonds, 30 kilograms of silver, 300 grams of gold, and rubies," Newadia claimed. The items were flown to Ayodhya in a special chartered aircraft. Mukesh Patel, who owns the Surat-based jewellery firm Green Lab, is well-known in the diamond trade and has previously supported religious and cultural initiatives. This latest donation, however, is among the most significant individual contributions made toward the ornamentation of the Ram Temple. The announcement comes just a day after a major milestone at the temple - the consecration of 'Raja Ram', or Lord Rama in his royal form. The ceremony included the installation of idols in eight newly constructed temples within the Ram Janmabhoomi complex and was attended by Uttar Pradesh Chief Minister Yogi Adityanath. This was the second major consecration ceremony at the site, following the January 22, 2024 installation of Ram Lalla, which was graced by Prime Minister Narendra Modi. The consecration ceremony has drawn large crowds to the sanctum sanctorum of the temple. Champat Rai, Secretary of the Ram temple trust, said that on Thursday, the temple completed the consecration ceremony of seven idols. He stated that the idols installed on the first floor above the sanctum sanctorum include Ram Darbar in the middle, a Shivalinga in the north eastern corner, a Ganapati idol in the southeastern corner, Hanumana idol in the middle of the southern side, Surya in the south western corner, Bhagwati in the north western corner, and Annapurna Mata in the middle of the northern side.
&w=3840&q=100)
Business Standard
27 minutes ago
- Business Standard
Huawei Band 10 with advanced health features launched: Check price, specs
Huawei Band 10 is priced at Rs 3,999 onwards and is offered in two case options: polymer case, and aluminium alloy case. The smart band will be available on e-commerce platform Amazon New Delhi
