
Dr Reddy's receives two USFDA observations for New York API facility
Dr Reddy's Laboratories
announced on Saturday that the United States Food and Drug Administration (
USFDA
) has issued a Form 483 with two observations following an inspection of its API (Active Pharmaceutical Ingredients) manufacturing facility in Middleburgh, New York.
In a regulatory filing, the Hyderabad-based pharmaceutical company stated that the GMP (Good Manufacturing Practice) inspection was carried out between May 12 and May 16, 2025, news agency PTI reported.
'At the conclusion of the inspection, we received a Form 483 with two observations, which we will address within the stipulated timeline,' the company said.
According to the USFDA, a Form 483 is issued when inspectors identify conditions that may potentially violate the Food, Drug, and Cosmetic (FD&C) Act or related regulations.
The observations are shared with a firm's management to prompt corrective action.
On May 16, Dr Reddy's Laboratories Ltd closed at Rs 1,228.50, marking a decline of Rs 7.80 or 0.63% from the previous trading session.
Earlier on Friday, Dr Reddy's Laboratories had reported a 21 per cent year-on-year increase in consolidated net profit to Rs 1,587 crore for the quarter ended March 2025, driven by strong sales across key markets such as the US and India.
by Taboola
by Taboola
Sponsored Links
Sponsored Links
Promoted Links
Promoted Links
You May Like
Avoid Emotional Trades in Volatile Markets – Master Swing with Hemant
TradeWise
Learn More
Undo
The Hyderabad-based pharmaceutical company had recorded a net profit of Rs 1,307 crore in the same quarter of the previous year. Revenue for the January–March quarter had risen to Rs 8,506 crore, compared to Rs 7,083 crore a year earlier, according to a regulatory filing.
For the full financial year 2024–25, Dr Reddy's had posted a net profit of Rs 5,724 crore, marking a modest 3 per cent growth over the Rs 5,568 crore reported in FY24.
The company's annual revenue had increased to Rs 32,553 crore from Rs 27,916 crore in the preceding fiscal.
India's Pharma sector
India's
pharmaceutical industry
, a major supplier to the United States, is likely to come under increasing pressure amid heightened regulatory scrutiny. In FY24, the US accounted for $8.7 billion of India's total pharma exports of $27.9 billion, according to the Pharmaceuticals Export Promotion Council of India.
More than 45% of the generic drugs used in the US are manufactured in India, underscoring the country's crucial role in the American healthcare system, according to an ET report.
Additionally, Indian firms supply approximately 15% of the biosimilars consumed in the US. Leading companies such as Sun Pharma, Dr Reddy's, Aurobindo Pharma, Zydus Lifesciences, and Gland Pharma generate up to half of their revenues from the US market, making them particularly sensitive to regulatory developments.
Stay informed with the latest
business
news, updates on
bank holidays
and
public holidays
.
AI Masterclass for Students. Upskill Young Ones Today!– Join Now
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Time of India
18 minutes ago
- Time of India
Market Wrap: D-Street ends higher on US trade talk optimism; Sensex adds 123 pts, Nifty above 25,100
Indian benchmark equity indices Sensex and Nifty ended in the green on Wednesday, lifted by gains in IT and oil & gas stocks, as positive cues from Asian markets and progress in trade talks between the U.S. and key partners like India and China boosted investor sentiment. The BSE Sensex advanced 123.42 points, or 0.15%, to settle at 82,515.14, while the NSE Nifty eked out a gain of 37.15 points, or 0.15% to close at 25,141.40. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Undo


Economic Times
19 minutes ago
- Economic Times
Sebi to launch UPI IDs for Sebi-registered entities that collect funds
Synopsis The new ecosystem will enable a secure and transparent payment system for investors to transact with registered intermediaries. Nikita Papers IPO opens on May 27, price band set at Rs 95-104 per share Nikita Papers IPO opens on May 27, price band set at Rs 95-104 per share Why gold prices could surpass $4,000: JP Morgan's bullish outlook explained Why gold prices could surpass $4,000: JP Morgan's bullish outlook explained Cyient shares fall over 9% after Q4 profit declines, core business underperforms Cyient shares fall over 9% after Q4 profit declines, core business underperforms L&T Technology Services shares slide 7% after Q4 profit dips L&T Technology Services shares slide 7% after Q4 profit dips Trump-Powell standoff puts U.S. Rate policy in crosshairs: Who will blink first? Trump-Powell standoff puts U.S. Rate policy in crosshairs: Who will blink first? SEBI warns of securities market frauds via YouTube, Facebook, X and more SEBI warns of securities market frauds via YouTube, Facebook, X and more API Trading for All: Pi42 CTO Satish Mishra on How Pi42 is Empowering Retail Traders API Trading for All: Pi42 CTO Satish Mishra on How Pi42 is Empowering Retail Traders Security, transparency, and innovation: What sets Pi42 apart in crypto trading Security, transparency, and innovation: What sets Pi42 apart in crypto trading Bitcoin, Ethereum, or Altcoins? How investors are structuring their crypto portfolios, Avinash Shekhar explains Bitcoin, Ethereum, or Altcoins? How investors are structuring their crypto portfolios, Avinash Shekhar explains The rise of Crypto Futures in India: Leverage, tax efficiency, and market maturity, Avinash Shekhar of Pi42 explains NEXT STORY


Mint
22 minutes ago
- Mint
S Chand's quiet masterclass: How a legacy publisher outmanoeuvred the edtech bust
MUMBAI: At a time when India's leading edtech firms are struggling with job cuts, financial write-downs, and investor fatigue, the 75-year-old S Chand and Company is providing a valuable lesson in measured and sustainable reinvention. The legacy education content publisher posted a 65% jump in operating income in FY25 and ended the year with over ₹100 crore in cash reserves, without raising fresh capital or going all-in on digital pivots. In an exclusive interview with Mint, Saurabh Mittal, chief financial officer of S Chand, said the company's focus has been clear: resist the hype, avoid overextension and double down on content that works across formats—print and digital alike. Also read: Education, manufacturing transformation key to India becoming developed: NITI Aayog chief executive 'Education is a staircase business, not an elevator business," Mittal said. 'We'd rather grow 8% and generate ₹100 crore in cash than chase 20% growth with just ₹50 crore in profits." The company's approach stands in contrast to the aggressive expansion and high burn rates that defined much of India's edtech sector in recent years. While players like BYJU's and Unacademy raised billions to build full-stack platforms, S Chand chose to stay conservative by cutting inefficiencies, expanding its digital content library and preparing its backend systems for modular deployment. Reinventing without the noise Delhi-based S Chand hasn't built its own tech platform. It hasn't acquired flashy startups. It doesn't spend on advertising. And yet, it has emerged from the Covid years leaner, more profitable and more agile. 'Our tech stack is fully consolidated, but we haven't tried to build it ourselves," Mittal said. 'Enough vendors are building good tools. We focus on content and let tech specialists handle distribution layers." The company's digital content library has expanded by nearly 30% over the last two years, with new content across national-level education boards CBSE, ICSE and NEP-aligned curricula. Test-prep material, tie-ups with educational YouTubers and QR-enabled Google Lens (image recognition technology) integrations are also part of the growing ecosystem. Print, however, remains the mainstay. 'K–8 books still drive the bulk of revenues," Mittal said. 'Despite the noise, most schools that switched to tablets have moved back to print. Books are cheaper, simpler to use and less distracting." Betting on NEP The ongoing implementation of India's National Education Policy (NEP) and new curriculum frameworks is proving to be a structural tailwind. As National Council of Educational Research and Training (NCERT) textbooks are updated and state boards begin aligning their syllabi, S Chand is often a first mover in content creation. Also read: Implement educational reforms in honour of Dr Kasturirangan (1940-2025) While Mittal acknowledged that states such as Tamil Nadu, West Bengal and Karnataka have resisted adopting the NCERT framework, he described the overall NEP-driven rollout as a tailwind. 'We already created NCF (national curriculum framework)-based content two years ago. Now we're mapping it to the actual NCERT textbooks as they come out," he said. The NEP 2020, which replaced the previous National Policy on Education of 1986, is a comprehensive education policy that aims to transform India's education system from early childhood to higher education. The NCF provides a roadmap for how to implement NEP's vision in classrooms through curriculum design, pedagogy, and assessment practices. The company is also looking to fill white spaces in its portfolio via selective acquisitions. Two potential targets are under active consideration—one in the exam-prep segment and another focused on international curriculum content such as Cambridge or International Baccalaureate (IB), areas where S Chand currently lacks scale. But the CFO is clear: valuations must be reasonable. 'Some players expect 2x revenue valuations. That's unrealistic in this category unless there's exceptional growth or margins," he said. 'We're not paying a premium when we ourselves are trading below that." Not competing, just enduring In many ways, S Chand's strategy is not to directly compete with high-decibel edtech brands, but to endure alongside them. The company positions itself as a content-first, platform-neutral player. 'We don't see ourselves competing with BYJU's or Physics Wallah," Mittal said. 'We're not trying to be a tech company. We're an education content company that delivers across formats." That stance has also helped the company sidestep the challenges faced by venture-funded edtech platforms, many of which expanded rapidly during Covid and are now cutting costs or winding down verticals. Also read: Despite high income, HNIs in India struggle with financial goals like retirement planning, childrens education: Report 'There was a lot of FOMO (fear of missing out) and hype during the pandemic. But learning outcomes were not always great. In fact, many schools and countries like those in Scandinavia have gone back to physical classrooms," Mittal noted. The company also avoids large marketing campaigns or brand-led spends. Growth is driven primarily by school relationships, workshops and teacher-enablement programmes. 'We do over 4,000 teacher workshops a year. That's where our impact is felt," he said. Preparing for the next decade Mittal acknowledged that higher education textbooks have seen a decline, with college students increasingly going digital. But the K–8 market, he said, remains resilient. For older students (Classes 9–12), hybrid learning is gaining some traction, but the overall addressable market is relatively small compared to early school years. Importantly, S Chand's content is already structured to go digital when required. 'Every book we create now has videos, assessments and platform-readiness built in," Mittal said. 'If a school wants to switch tomorrow, we're ready." Even though it has explored monetizing its digital intellectual properties (IPs) or spinning off subsidiaries in the past, the company is now focused on internal consolidation. 'We're merging entities back to stay efficient. Raising funds just for the sake of it doesn't make sense," he said. Re-engaging with investors Having stayed quiet on the investor front in recent years, S Chand is now preparing to re-engage with capital markets. 'We wanted first to deliver consistent results. Now that we've done that, it's time to go out and grab more eyeballs," Mittal said. After decades in print and a public listing in 2017, the company's current evolution is quiet, yet noteworthy, characterized by a lean, profitable and selective approach. While the edtech giants chased velocity, S Chand stayed grounded and is now reaping the dividends.