Stay updated with the latest food-and-drug-administration news, articles, and insights from trusted sources. Explore in-depth coverage and expert analysis on food-and-drug-administration topics.
New Delhi, Apr 9 (PTI) Glenmark Pharmaceuticals on Thursday said it has received final approval from the US health regulator for its generic version of progesterone vaginal inserts used in fertility treatments. The approval by the US Food and Drug Administration (USFDA) is for progesterone vaginal inserts of strength 100 mg, Glenmark Pharmaceuticals Ltd said in a regulatory filing. It has been determined by the USFDA to be bioequivalent and therapeutically equivalent to the reference listed dr ...Read More >
Bosch Ltd | Technology and services provider firm, has approved the acquisition of a 100% stake in Bosch Chassis Systems India for ₹9,068.68 crore from its group entities. Lupin | The pharma company has received USFDA approval for its Dapagliflozin and Metformin extended-release tablets in multiple strengths, boosting its US diabetes portfolio. Earnings | Tata Consultancy Services, Anand Rathi Wealth Ltd, and GM Breweries Ltd are set to report their Q4 results on April 9, with investors also ...Read More >
Gail (India) jumped 5.71% to Rs 153.55 after the company said that it has entered into a long-term charter party agreement with Alpha Gas, a leading Greek shipping major, for the LNG carrier "Energy Fidelity." The charter party agreement was executed between GAIL and Pantheon Maritime Services, a Singapore based affiliate of Alpha Gas. The LNG carrier Energy Fidelity, with a cargo capacity of 174,000 cubic meters, is equipped with two-stroke propulsion system, complemented by advanced air lubr ...Read More >
Ahmedabad: Zydus Lifesciences has expanded its presence in the U.S. generics market with a key regulatory approval for a widely used diabetes treatment. Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for Dapagliflozin Tablets in 5 mg and 10 mg strengths. This approval enables the company to enter the U.S. market with a generic version of the drug, broadening its portfolio in a high-demand therapeutic category. With the approval, Zydus ...Read More >
Bengaluru: Biocon Limited has achieved a regulatory milestone in the United States, reinforcing its presence in the global diabetes treatment market. Biocon Pharma Limited, a subsidiary of Biocon Limited, has received approval from the U.S. Food and Drug Administration for Dapagliflozin Tablets in 5 mg and 10 mg strengths. The approval enables the company to market the drug for adults with type 2 diabetes mellitus, expanding its footprint in one of the world's largest pharmaceutical markets. T ...Read More >
New Delhi, Apr 8 (PTI) Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of dapagliflozin tablets indicated to control blood sugar in adults with type 2 diabetes mellitus. The approval by the US Food and Drug Administration (USFDA) is for dapagliflozin tablets of strengths 5 mg and 10 mg, Zydus Lifesciences said in a regulatory filing. Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycaemic co ...Read More >
New Delhi, Apr 7 (PTI) Aurobindo Pharma on Tuesday said it has received final approval from the US health regulator for its generic version of dapagliflozin tablets used to control blood sugar levels in people with type 2 diabetes. The final approval granted by the US Food & Drug Administration (USFDA) to manufacture and market dapagliflozin tablets is for strengths 5 mg and 10 mg, Aurobindo Pharma said in a regulatory filing. These are bioequivalent and therapeutically equivalent to the refer ...Read More >
New Delhi: Biocon Ltd on Tuesday announced the commercial launch of biosimilars Bosaya and Aukelso, indicated for different serious bone conditions, in the US. Bosaya (biosimilar to Prolia) and Aukelso (biosimilar to Xgeva) are now available by prescription nationwide through specialty pharmacies and healthcare providers, Biocon said in a statement. Also Read: Biocon not to rush generic semaglutide to packed India market, says incoming CEO Shreehas Tambe Both products have been previously app ...Read More >
New Delhi, Apr 7 (PTI) Biocon Ltd on Tuesday announced the commercial launch of biosimilars Bosaya and Aukelso, indicated for different serious bone conditions, in the US. Bosaya (biosimilar to Prolia) and Aukelso (biosimilar to Xgeva) are now available by prescription nationwide through specialty pharmacies and healthcare providers, Biocon said in a statement. Both products have been previously approved and granted interchangeable designation by the US Food and Drug Administration in Septembe ...Read More >
Hyderabad: CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, on Monday said it has reported positive top-line Phase 3 results for BP11, its investigational biosimilar to Xolair, or omalizumab.CuraTeQ said the study met all primary endpoints in patients with chronic spontaneous urticaria receiving the 300 mg dose, demonstrating high comparability with the reference product. The company said it plans to use the results to support regulatory submissions for chronic spontaneous urtic ...Read More >
Hyderabad, April 6 (RAHNUMA): CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has announced positive top-line results from its Phase 3 trial of BP11, an investigational biosimilar to Omalizumab (marketed as Xolair). The study met all primary endpoints, demonstrating strong comparability with the reference drug in treating chronic spontaneous urticaria (CSU) at a 300 mg dose. Conducted across 608 patients at nearly 80 sites in Europe and India, the trial showed precise equivalence in itch s ...Read More >
Chennai: The US has imposed 100 per cent duty on the import of patented pharmaceuticals and associated pharmaceutical ingredients. Generic drugs have been kept out of the duty for the time being. But, if pharma companies increasingly seek evergreening of patents, they will see fewer off-patented drugs in the pipeline. "I have determined that it is necessary and appropriate to impose a 100 percent ad valorem duty rate on the import of patented pharmaceuticals and associated pharmaceutical ingred ...Read More >
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 regulat ...Read More >
Mumbai, Apr 2 (PTI) The Association of PET Recyclers (Bharat) has said that the notification on final guidelines mandating the use of 40 per cent recycled content in food-grade packaging from April 1 is a "progressive step" which is expected to significantly ease the supply chain disruptions caused due to recent geopolitical uncertainties impacting both availability and pricing of virgin PET. In a statement on Thursday, the Association's Director General Goutham Jain said that it also marks a s ...Read More >
April 1 (Reuters) - U.S. stock futures advanced on Wednesday, after the indexes saw their biggest one-day gains in nearly a year in the previous session, following President Donald Trump's comments that suggested a swift end to the Middle East conflict. Trump and Secretary of State Marco Rubio said on Tuesday that the end of the Iran war could be near, signaling potential for both direct talks with Iranian leadership and a winding down of the conflict without a deal. Trump is scheduled to addre ...Read More >
New Delhi, April 1 (SocialNews.XYZ) Association of PET Recyclers (APR) Bharat on Wednesday said that the government guidelines mandating brands and producers to use 40 per cent recycled content in food‑grade PET packaging effective April 1 will boost India's circular economy, a report said on Wednesday. The move marks a significant milestone in the country's commitment to sustainable resource management amidst global supply disruptions and geopolitical uncertainties impacting the availability a ...Read More >
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 ...Read More >
Mumbai, Mar 31 (PTI) The Mumbai police have registered a case against the brother of a transperson in connection with the circulation of an alleged artificial intelligence-doctored video featuring Maharashtra Minister and NCP leader Narhari Zirwal, an official said on Tuesday. Zirwal landed in a controversy last week after an "objectionable" video of him surfaced on social media. The purported video showed the Minister of Food and Drug Administration in a compromising position with a transperso ...Read More >
Mumbai/Naples: Lupin has taken a step forward in expanding its U.S. generics portfolio, securing regulatory progress for a key injectable product used in surgical care. Lupin has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Sugammadex Injection. The approval covers two dosage strengths -- 200 mg/2 mL and 500 mg/5 mL -- both in single-dose vial formats. The company's product has been deemed bioequivalent to Merck's Bridion i ...Read More >
Nashik: During the recent legislative session, a viral video allegedly showing then minister Manikrao Kokate playing rummy inside the assembly had led to a change in his portfolio and eventually made his resignation unavoidable. Now, another minister from the district, Narahari Zirwal, finds himself in a difficult position after a clerk from the Food and Drug Administration department was caught red-handed accepting a bribe of ₹35,000 by the Anti-Corruption Bureau (ACB). The opposition has dema ...Read More >
New Delhi, Dec 17 (PTI) Medical devices firm Healthium Medtech on Wednesday announced acquisition of a controlling stake in Paramount Surgimed Ltd. Paramount Surgimed is one of India's largest manufacturers and exporters of surgical blades, scalpels and dermal biopsy products. The non-surgical business of Paramount, including its lifestyle and hygiene business will be carved out prior to the transaction and retained with its promoter Grover family, Healthium Medtech said in a statement. The a ...Read More >
Karnataka Health Minister Dinesh Gundu Rao said the state government will appoint separate nodal officers in all districts and consider strengthening legislation to curb female foeticides. Intelligence gathering, decoy operations, and stricter enforcement of PC & PNDT Act are underway Belagavi (Karnataka): Accepting that the female foeticide has not stopped in the state, Karnataka Health Minister Dinesh Gundu Rao on Tuesday said that the government is taking strict measures to prevent it. The ...Read More >
Ahmedabad -- Senores Pharmaceuticals Limited today announced that it has entered into a definitive agreement to acquire 100% equity stake in Apnar Pharma Private Limited ("Apnar Pharma"), along with the acquisition of five Abbreviated New Drug Applications (ANDAs), marking a significant milestone in Senores' growth strategy across regulated pharmaceutical markets. Apnar Pharma, incorporated on December 12, 2014, is a privately held pharmaceutical company engaged in the licensing, development, a ...Read More >
(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 Co ...Read More >
Mumbai, Oct 31 (SocialNews.XYZ) Actress Deepika Padukone, who has been a strong advocate for mental health awareness, reacted to cricketer Jemimah Rodrigues' recent revelation about battling anxiety. The 'Om Shanti Om' actress, known for openly sharing her own struggles with depression in the past, praised Jemimah for her honesty and courage in speaking up, highlighting the importance of conversations around mental well-being in sports and beyond. Taking to her Instagram Stories, Deepika Paduko ...Read More >
New Delhi [India], October 31 (ANI): The U.S. Food and Drug Administration (FDA) has announced major steps to make it faster and less costly to develop biosimilar medicines, lower-cost "generic" alternatives to biologic drugs used to treat serious and chronic diseases. In a new draft guidance, the FDA has proposed major updates aimed at simplifying biosimilarity studies and reducing unnecessary clinical testing. The agency also launched a separate initiative to make it easier for biosimilars t ...Read More >
Acting on a tip-off about the sale of the contraband from a residential property in the Kasarwadavali area, the police raided the premises on Tuesday, he said. The cops seized various brands of banned gutka and tobacco products, valued at about Rs 46 lakh, and booked two persons, identified as Nilesh Chalwade (35) and Satyaban Behra (32), reported PTI. A case has been registered against Chalwade and Behra under the Bharatiya Nyaya Sanhita (BNS) and the Food and Drug Administration (FDA) Act, r ...Read More >
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 regulat ...Read More >
The owner of a Tamil Nadu firm, Ranganathan Govindan, has been remanded in judicial custody in connection with the deaths of over 20 children in Madhya Pradesh due to contaminated cough syrup. The firm's manufacturing unit has been sealed, and other individuals involved, including a doctor who prescribed the syrup, are already in custody. Ranganathan Govindan, owner of a Tamil Nadu-based firm that manufactured contaminated cough syrup 'Coldrif' linked to the deaths of more than 20 children in M ...Read More >
Mangaluru, Oct. 18: The Hindu Janajagruti Samiti (HJS) has launched a nationwide campaign titled "Halal-Free Diwali", urging citizens to reject products bearing halal certification. The organisation claimed that the halal certification system poses a threat to India's secular framework and called upon the government to ban it. According to the HJS, what began as a certification system limited to meat products has now expanded to include everyday commodities such as sugar, flour, oil, cosmetics ...Read More >
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