logo
Dr Reddy's receives two USFDA observations for New York API facility

Dr Reddy's receives two USFDA observations for New York API facility

Time of India17-05-2025

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

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Minda Corporation enters into JV with Japan-based Toyodenso Co.
Minda Corporation enters into JV with Japan-based Toyodenso Co.

Business Standard

time4 minutes ago

  • Business Standard

Minda Corporation enters into JV with Japan-based Toyodenso Co.

To manufacture advance automotive switches for Indian market Minda Corporation announced a Joint Venture with Japan-based Toyodenso Co. for advance automotive switches for the Indian market. The partnership will provide end-to end solutions including design, development, manufacturing and marketing of Automotive Switches for two-wheelers, Passenger Cars and other automotive segment for the Indian market. Minda Corporation will have majority stake in the newly formed venture with an investment in the agreed shareholding ratio of 60:40. The new Joint venture has already received orders from customers in India. This greenfield plant will be set up in Noida, Uttar Pradesh and is expected to commence operations by 2nd half of FY 2026-27. This partnership is strategically aligned to cater to the rising demand for advanced switches in the Indian automotive sector and in line with the company synergistic product portfolio and localization of new products and technologies for the customers. Through this partnership, Toyodenso will bring new technologies and advanced engineering capabilities while Minda Corporation will contribute with its deep expertise in localised manufacturing, and robust supply chain ecosystem etc.

Hindustan Zinc Ltd spurts 0.57%, gains for fifth straight session
Hindustan Zinc Ltd spurts 0.57%, gains for fifth straight session

Business Standard

time4 minutes ago

  • Business Standard

Hindustan Zinc Ltd spurts 0.57%, gains for fifth straight session

Hindustan Zinc Ltd is quoting at Rs 537.1, up 0.57% on the day as on 12:44 IST on the NSE. The stock is down 21.96% in last one year as compared to a 8.05% jump in NIFTY and a 2.8% jump in the Nifty Metal. Hindustan Zinc Ltd is up for a fifth straight session today. The stock is quoting at Rs 537.1, up 0.57% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.38% on the day, quoting at 25199.55. The Sensex is at 82711.36, up 0.39%. Hindustan Zinc Ltd has gained around 23.49% in last one month. Meanwhile, Nifty Metal index of which Hindustan Zinc Ltd is a constituent, has gained around 7.28% in last one month and is currently quoting at 9509.7, up 0.56% on the day. The volume in the stock stood at 30.01 lakh shares today, compared to the daily average of 43.29 lakh shares in last one month. The benchmark June futures contract for the stock is quoting at Rs 533.9, up 0.52% on the day. Hindustan Zinc Ltd is down 21.96% in last one year as compared to a 8.05% jump in NIFTY and a 2.8% jump in the Nifty Metal index. The PE of the stock is 21.8 based on TTM earnings ending March 25.

S'pore-backed Prestige Estates Projects bets on India's entertainment boom
S'pore-backed Prestige Estates Projects bets on India's entertainment boom

Business Standard

time4 minutes ago

  • Business Standard

S'pore-backed Prestige Estates Projects bets on India's entertainment boom

The developer, which counts Blackrock Inc. and Vanguard Inc. as its investors, plans to allocate 40 per cent space in malls to entertainment and restaurants Bloomberg Prestige Estates Projects Ltd., which ranks among India's top five real estate developers by market value, is looking to sell more entertainment and dining spaces in malls while cutting back on apparel retailers, a top official said. 'Shopping can be done from anywhere once you know the brand, entertainment cannot be bought online,' Muhammed Ali, chief executive officer-retail of the Singapore government-backed firm said over phone. The developer, which counts Blackrock Inc. and Vanguard Inc. as its investors, plans to allocate 40 per cent space in malls to entertainment and restaurants, twice of what its older properties offer. At the same time, retail space will be cut from as much as 85 per cent to 60 per cent, Ali added. His strategy mirrors the rapid transformation in India's consumer landscape driven by a combination of rising income levels, aspirations and demographics. It also comes as e-commerce is challenging traditional retail, and malls are trying to reposition themselves as experience-driven destinations with shopping, leisure and lifestyle thrown in the mix. India's top cinema chain PVR Inox Ltd. is betting on a slew of big-ticket Bollywood and Hollywood releases to bring back audiences while consultancy firm Mordor Intelligence notes that quick service restaurants are seeing a steady rise in average order value and increasingly establishing themselves in retail spaces to capture a broader customer base. Prestige plans to grow its presence to 15 malls spanning 10 million square feet in cities such as Bangalore, Mumbai, Hyderabad, and Goa by 2030. It operates four malls at present. Prestige is expanding the scope of entertainment to include physical activities that engage people of all ages and help them 'burn a few hundred calories.' Prestige shares have fallen 11 per cent over the last year, nearly twice the decline in the NSE Realty index. The company's profit for the year ended March 31 was down 62 per cent on year to Rs 6.16 billion ($72.1 million), the lowest in five years. Live Performances Analysts at JM Financial said in a note on Monday that they expect growth in residential sales to moderate after surging in the last two to three years. That makes it imperative for Prestige and other developers to diversify their revenue stream. 'These are the things that online cannot compete with us, where senses are involved, where you need to physically be there,' said Ali, referring to entertainment and dining. The company is also focused on live performances. The new mall structure is expected to generate around 12.50 billion rupees in rentals annually by 2030, Ali said. That is a sixfold jump from a little over rupees two billion the company made in rentals in the financial year through March 2025. 'We are challenging the status quo. These malls are going to be very exciting platforms,' said Ali.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store