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
35 minutes ago
- Time of India
Did Elon Musk use ketamine, ecstasy drugs? What Donald Trump said
Elon Musk with Donald Trump (File photo) US President Donald Trump on Monday responded cautiously to recent reports alleging Elon Musk used recreational drugs while advising his administration, calling the claims troubling but unverified. "I really don't know. I don't think so," Trump told reporters on June 9 when asked whether Musk had brought drugs into the White House. "I hope not." The remark marks Trump's first major comment on the issue since The New York Times reported in late May that Musk had allegedly used ketamine, ecstasy, and psychedelic mushrooms while campaigning with Trump in 2024. The report cited unnamed sources. Musk swiftly responded to the allegations in a post on X: "You can tell immediately that someone is a massive liar if they're claiming I'm on drugs, as I am one of the most photographed people on Earth and am in meetings 7 days a week!" He added that he underwent random drug testing for nearly three years following a widely-publicized 2018 podcast appearance with Joe Rogan . "Not the slightest trace of drugs or alcohol was found." USA Today reported it remains unclear whether Musk used any substances while serving in an official capacity. When asked about it on his final day as a special government employee, Musk avoided the question, saying, 'Let's move on.' The drug allegations come amid a broader fallout between Trump and Musk. Their once-close relationship soured after Musk denounced Trump's tax and spending package as a 'disgusting abomination.' by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Sanitize & Smooth Clothes Fast with Philips Steamer Philips Garment Steamers Shop Now Undo Trump retaliated by suggesting he might scale back federal contracts held by Musk's companies, while Musk hinted that Trump appeared in classified files related to convicted sex offender Jeffrey Epstein. Despite the tensions, signs of de-escalation have emerged. Trump took a softer stance when asked about Musk's satellite internet company, Starlink. 'It's a good service,' he said, indicating no plans to discontinue its use at the White House. He also struck a conciliatory note personally, saying: 'We had a good relationship, and I just wish him well.' The highly public spat has complicated Republican efforts to pass Trump's 'big, beautiful bill' in Congress, where the GOP holds narrow majorities. However, with Musk deleting earlier posts—some of which had supported impeachment—insiders suggest the billionaire may be ready to mend ties with the president.
Time of India
39 minutes ago
- Time of India
8th Pay Commission salary hike may miss January 2026 deadline: Will it impact fitment factor calculation?
Why the 8th Pay Commission might be delayed beyond January 2026? Live Events Fitment factor Dearness Allowance (DA) to be merged with basic pay Pensioners may see revised benefits What government employees should prepare for For nearly 35 lakh central government employees and over 67 lakh pensioners, the 8th Pay Commission has become a source of speculation. With growing chatter around possible pay hikes and revised pension benefits, expectations are soaring. Despite the excitement, there's still no official word from the government on when the 8th Pay Commission will be constituted, leaving many in employee unions have begun voicing concern over the delay, urging the government to form the Commission well in advance to ensure timely implementation and reduce uncertainty for both employees and 7th Pay Commission, which came into effect in January 2016, was announced nearly two years prior, in February 2014. That timeline gave enough room for report submission, cabinet approval, and a timely rollout. However, as of mid-2025, the 8th Pay Commission is yet to be formed, and the crucial Terms of Reference (ToR), which define the scope and goals of the commission, haven't been finalised officials have confirmed that internal discussions are underway, but given the pace of bureaucratic processes, the rollout may stretch well beyond the expected January 1, 2026 timeline. Even if the Commission is announced by the end of this year, historical patterns indicate a gap of 18-24 months before the recommendations are ready for implementation. At this pace, the hike might only materialise by late 2026 or early to the delay are fiscal constraints, with the government balancing welfare spending, election promises, and fiscal deficit targets. A generous hike could significantly strain the exchequer, prompting policymakers to tread carefully.A major part of the salary revision hinges on the fitment factor, Fitment factor is the number used to recalculate an employee's basic salary. In the 7th Pay Commission, this was set at 2.57, raising the minimum pay from Rs 7,000 to Rs 18,000. Going by the views expressed by various experts 8th Pay Commission could recommend a fitment factor between 2.5 and 2.86. "Considering the inflation factor, there are indications that the fitment factor may stay between 2.5- 2.8 times, which will give a significant boost to employee salaries between Rs 40,000 and Rs 45,000," says Krishnendu Chatterjee, Vice President at the top-end 2.86 figure is accepted, the minimum basic salary could climb to over Rs 51,000. However, due to its fiscal implications, such a steep hike may be challenging. A 2.6x to 2.7x hike appears to be more likely, providing a significant increase while keeping the government's finances in fitment factor for the 7th Pay Commission was 2.57 and the minimum basic salary was hiked to Rs 18,000 from Rs 7,000. For the 6th Pay Commission, the fitment factor was 1.86 and the minimum basic salary was raised from Rs 2,750 to Rs 7, likely shift is the merger of the Dearness Allowance with the basic salary. Currently pegged at around 55% effective from January 2025, DA helps offset the impact of inflation and is revised twice in a year. Before the effective date of 8th Pay Commission early next year, there is one more DA hike is due to be announced in coming months which will be effective from July 2025. When a new Pay Commission is implemented, DA accumulated up to that point is typically merged into the revised basic this increases the overall salary package, it also means future DA hikes start from zero. Employees will see a rise in gross salary and related allowances, such as HRA and transport, but may also experience low DA in the near term. However, a higher base salary will mean that each DA hike will mean a higher increase in implementation of the 8th Pay Commission is not only being eagerly awaited by salaried employees. Nearly 67 lakh government pensioners are also impacted by any revision in the pay scale. Previous Pay Commissions have included changes in pension calculation formulas and benefits, and similar adjustments are expected this time as merger of Dearness Relief (DR) into basic pension also affects pensioners, as their payouts are tied to similar structures. Any revision in the base figures could significantly alter monthly pension employees' associations have echoed the concerns of serving staff, pushing for greater clarity from the government on how pension recalculations will be carried out in the new the uncertainty, a few things seem inevitable. A revised pay structure is coming, but it may take longer than expected. The eventual hike could push minimum salaries up to Rs 40,000 - Rs 45,000, with pension adjustments following suit. DA will reset, but higher allowances may offset the initial flattening in salary government staff would do well to temper expectations, at least in terms of timing. The gains could be significant, but the road to them may be more drawn out than previous 8th Pay Commission is aimed to deliver significant financial changes for government employees and pensioners. Yet, the pace of bureaucracy, pending approvals, and fiscal balancing may delay the implementation beyond the earlier-set target of January 2026.
India.com
39 minutes ago
- India.com
This company's shares gain amid volatility in market
शेयर बाजार में हाहाकार, अरबों डॉलर हुए स्वाहा Mercury EV-Tech Ltd., a Gujarat-based electric vehicle solutions provider, launched a new EV showroom in Bhavnagar. This resulted in a 2.2% share price increase to Rs 62.75 on Tuesday, from the previous closing price of Rs 61.40. However, profit-taking and market volatility led to a significant reduction in gains. At 1:21 pm, shares were trading up 0.5 percent at Rs 61.70 on the BSE. The 52-week high and low are Rs 139.20 and Rs 51.24 per share, respectively. The company boasts a market capitalization exceeding Rs 1,100 crore, with strong Q4FY25 and FY25 financial results. Quarterly net sales surged 451% to Rs 30.68 crore, and net profit increased by 47% to Rs 1.34 crore compared to Q4FY24. Annually, net sales grew 307% to Rs 89.64 crore in FY25, while net profit rose 286% to Rs 7.70 crore compared to FY24. Since reaching its 52-week low of Rs 51.24 per share, the stock has appreciated by 22.5%. FY25 saw new Foreign Institutional Investor (FII) participation, with the acquisition of 36,43,605 shares, representing a 1.92% increase over FY24. The stock has delivered multibagger returns of 6,550% over three years and a remarkable 17,065% over five years.
