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8
BusinessOct 22, 2025 06:32 AM

Dr Reddy's Srikakulam unit classified as voluntary action indicated by USFDA

Dr Reddy's Laboratories has received a report from the US Food and Drug Administration. The report concerns its manufacturing facility in Srikakulam, Andhra Pradesh. The USFDA has classified the inspection outcome as Voluntary Action Indicated. This means the inspection is officially closed. The company received the Establishment Inspection Report on October 20, 2025. Drugmaker Dr Reddy's Laboratories Ltd on Tuesday said it has received establishment inspection report from the US health regulato

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BusinessApr 03, 2026 04:34 PM

Granules Life Sciences' Hyderabad plant gets VAI inspection classification from U.S. FDA

Granules Life Sciences (GLS) manufacturing facility in Shamirpet, near Hyderabad, has been classified as voluntary action indicated (VAI) by the U.S. Food and Drug Administration (U.S. FDA) consequent to an inspection in December 2025. The establishment inspection report (EIR) was issued following a current good manufacturing practice (cGMP) and pre-approval inspection (PAI) of the oral solid dosage manufacturing operations between December 15 and 19. The inspection is now closed and no regulato ...Read More >

34
BusinessSep 15, 2025 08:44 AM

Stocks in news: GMR Airports, RailTel, Adani Power, Dr Reddy's, Bajaj Housing Finance

Indian markets saw gains on Friday. Britannia Industries is focusing on localized strategies. Hyundai aims for growth through domestic sales and exports. Alembic Pharma received US FDA EIR. Diamond Power secured a Rs 236 crore order from Adani Energy. GMR Airports reported a passenger traffic decline. RailTel received a Rs 209 crore order. Markets extended their winning streak on Friday, gaining nearly half a percent, in line with favorable global and domestic cues. In today's trade, shares of G ...Read More >

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BusinessDec 15, 2025 10:15 AM

Indian Shares Open Lower In Cautious Trade

(RTTNews) - Indian shares were moving lower on Monday amid concerns over persistent selling by FIIs and renewed uncertainty around U.S.-India trade negotiations. Global sentiment also remains fragile as investors continue to reduce exposure to tech stocks on valuation concerns. The benchmark BSE Sensex was down 320 points, or 0.4 percent, at 84,946 in early trade, while the broader NSE Nifty index dipped 105 points, or 0.4 percent, to 25,941. Among the prominent decliners, TMPV, Power Grid Corp, Bajaj FinServ and Mahindra & Mahindra fell 1-2 percent. Dr Reddy's Laboratories fell about 1 pe ...Read More >

31
BusinessJul 15, 2025 02:20 AM

Glenmark Pharma shares in focus after USFDA warning to Indore plant

Glenmark Pharmaceuticals disclosed receiving a warning letter from the U.S. FDA for its Indore facility following a February inspection. The company clarified that the letter won't impact existing supplies or revenues. It also emphasized its commitment to compliance and noted no data integrity issues were found. Glenmark Pharmaceuticals shares may be in focus on Monday, July 14, after the company disclosed that it has received a warning letter from the U.S. Food and Drug Administration (FDA) for ...Read More >

13
BusinessOct 16, 2025 02:34 PM

Lords Mark Industries Ltd. secures US FDA Registration, Reinforces India's Position in Global Healthcare Manufacturing

Lords Mark Industries Ltd. secures US FDA Registration, Reinforces India's Position in Global Healthcare Manufacturing . 4 min read Last Updated : Oct 13 2025 | 1:16 PM IST Mumbai, October 11, 2025: Lords Mark Industries Ltd., has received US FDA registration for its range of surgical consumables, orthopedic supports, and hygiene products -- a milestone that reinforces its manufacturing excellence and strengthens India's position in the global healthcare supply chain. US FDA registration repr ...Read More >

18
BusinessNov 29, 2024 10:48 AM

Dr. Reddy's launches Toripalimab in India for treatment of Nasopharyngeal Carcinoma

First & only immuno-oncology drug approved by various regulatory authorities around the world Dr. Reddy's Laboratories has announced the launch of Toripalimab in India. Toripalimab is a New Biological Entity (NBE). It is the only immuno-oncology drug approved by various regulatory authorities around the world such as United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). In 2023, Dr. Reddy's entered in ...Read More >

7
BusinessDec 03, 2024 03:01 PM

Granules India shares crack 10% after Hyderabad facility gets a rap from US regulator

Granules India shares slipped sharply in trade, down nearly 10% after the company informed that US FDA has classified the inspection at Gagillapur facility in Hyderabad, Telangana as an 'Official Action Indicated' (OAI). The exchanges were informed about an inspection at the facility on September 7, which had resulted in a Form 483 issuance with six observations. Now, Granules India has said that it has responded to 'all the observations' issued by the USFDA. "The Company has responded to all the observations issued by the US FDA. Additionally, the Company has voluntarily undertaken a compr ...Read More >

9
BusinessApr 01, 2026 11:27 AM

Granules Life Sciences Receives VAI Classification following US FDA Inspection - APN News | Authentic Press Network News

Hyderabad : Granules India Limited today announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has concluded a recent US FDA inspection of its manufacturing facility at Shamirpet, Telangana, with an inspection classification of Voluntary Action Indicated (VAI). The Establishment Inspection Report (EIR) was issued following a current Good Manufacturing Practice (cGMP) and pre approval inspection (PAI) of the oral solid dosage manufacturing operations conducted between December 15 and 19, 2025. The inspection is now closed, and no regulatory action has been ...Read More >

16
BusinessSep 15, 2025 08:15 AM

Stocks to Buy or Sell Today, September 15, 2025: Apollo Hospitals, GMR Airport, RailTel Corporation Among Shares That May Remain in Focus on Monday | LatestLY

New Delhi, September 15: Dalal Street is expected to see selective stock action on Monday, September 15, as several companies announced key updates over the weekend. Market sentiment may remain stock-specific, with developments spanning acquisitions, order wins, regulatory observations, and fundraising plans. Investors are likely to track healthcare, infrastructure, and power sector plays closely, alongside midcaps riding on new contracts. Global cues and domestic macro trends will set the broader tone, but these individual stocks could see heightened activity based on fresh news flow. Trader ...Read More >