
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


Deccan Herald
33 minutes ago
- Deccan Herald
Karnataka govt to roll out smartcards for Shakti scheme beneficiaries in two months
Launched as the first of the Congress government's five guarantees on June 11, 2023, the scheme has been a runaway hit. A staggering 474 crore tickets were issued until Tuesday, costing the government Rs 11,994.37 crore.


Deccan Herald
an hour ago
- Deccan Herald
Dharavi's big rebuild: Between uplift and uprooting, will its spirit endure?
Last month, Maharashtra Chief Minister Devendra Fadnavis approved the Dharavi Redevelopment Master Plan, a colossal project with an investment of a whopping Rs 95,790 crore.


Time of India
an hour ago
- Time of India
‘Resume direct flights, reduce hotel tariffs to revive tourism in Kashmir'
Srinagar: The travel trade industry has appealed to airlines to resume flights to Srinagar that were discontinued after the Pahalgam terror attack on April 22 so that tourism in Kashmir can revive. Tired of too many ads? go ad free now While all flights to Srinagar, Jammu and over two dozen other areas were suspended in May, as India conducted air strikes against terror hubs in Pakistan, some services including direct flights from Kolkata to Srinagar by IndiGo Airlines and Air India Express have not resumed after hostilities ceased on May 10. IndiGo has indicated that it will resume the direct flight from June 16. Last month, TOI wrote about the 'Chalo Kashmir' campaign, a strong community-tourism industry connect initiative launched by the Travel Agents' Association of India (TAAI), which handles around 4 lakh tourists from Kolkata in a year, around 40,000 of whom travel to Kashmir. Taking the campaign forward, TAAI started a new campaign called Rally for Valley to boost tourism in Kashmir. "We are in talks with the Union govt as well as airlines and hotel bodies to put a cap on tariffs that can help us shape attractive packages for tourists," said TAAI president Sunil Kumar. "As for safety, we are visiting the valley with our families. Tourists have nothing to fear. People here are among the most hospitable. This is the best time to visit the Valley," he added. Over 15 lakh tourists visited Kashmir last year. The Valley was packed with tourists again this year before the terror attack triggered mass cancellations. The downturn in tourists has hit Kashmiris hard. "In April, we were charging Rs 5,000 for a round trip to Pahalgam from Srinagar. Now we are taking tourists even for Rs 3,000," said Md Rouf, a driver. Restaurants like Lazeez, which had to turn down guests two months back, are now giving special offers to fill tables. Tired of too many ads? go ad free now "Very few rooms have been booked across several hotels. Had it not been for the terror attacks, these hotels would have been packed. These hotels should take a Covid-time-like approach and cut down on tariffs. We have set ourselves a target until Sept this year by when we intend to revive tourism back in Kashmir," said TAAI chairman (east) Anjani Dhanuka. The newly inaugurated Vande Bharat Express, travelling through the landmark Chenab Bridge, is also being promoted as a game changer. "Kolkata will host the first roadshow promoting Kashmir as a safe destination. We are also regularly updating our social media handles with snippets and current activities in popular destinations in Srinagar, Pahalgam, Jammu, Gulmarg, Sonmarg, and other places to encourage tourists from Kolkata," said Manav Soni, TAAI national committee member.