Usfda

Glenmark receives USFDA approval for generic progesterone vaginal inserts

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 drug, Endometrin vaginal inserts, 100 mg of Ferring Pharmaceuticals Inc, it added. Glenmark's progesterone vaginal inserts 100 mg will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, the company said. "This approval for Progesterone Vaginal Inserts, 100 mg marks an important addition to our business and reinforces our focus on addressing patient needs in women's healthcare," Glenmark President & Business Head, North America, Marc Kikuchi said. Citing IQVIA sales data for the 12 months ended February ..

Alembic Pharma receives USFDA approval for generic dapagliflozin tablets

Alembic Pharmaceuticals Ltd 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 approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of dapagliflozin tablets of strengths 5 mg and 10 mg, Alembic Pharmaceuticals Ltd said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca), it added. Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. With this approval, Alembic is eligible for 180 days of shared generic drug marketing exclusivity, the company said. Dapagliflozin tablet is indicated to reduce the risk of hospitalisation for heart failure in adults with ...

Lupin gets tentative nod from USFDA for generic Sugammadex injection

Pharma major Lupin Ltd on Tuesday said it has received tentative approval from the US health regulator for its generic version of Sugammadex injection used for reversing the effects of muscle relaxants given during surgery. The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial, Lupin said in a regulatory filing. The USFDA has tentatively approved Lupin's Sugammadex injection of the specified strengths as bioequivalent to Merck's Bridion injection, it added. It is used for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, the company said.

Aurobindo gains 3%, stock hits 52-week high; JM Financial sees more upside

In the past one month, Aurobindo has outperformed the market by surging 9 per cent, as compared to 8.5 per cent decline in the BSE Sensex.

Natco rallies 5%, nears 52-week high; what's driving pharma stock?

In the past four trading days, the stock price of Natco Pharma has surged 10 per cent after the company announced the launch of Pomalidomide Capsules (generic of Pomalyst) in the US market.

Cipla's US unit recalls 400+ cartons of generic anti-cancer drug: USFDA

A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US Food and Drug Administration (USFDA). Warren (New Jersey)-based Cipla USA, Inc is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the US health regulator said in its latest Enforcement Report. The company is recalling the affected lot (271 and 164 cartons) due to "failed tablet/capsule specifications", it stated. Cipla USA, Inc initiated the Class III voluntary recall on February 18 this year. According to the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". Nilotinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. India has the highest number of USFDA-compliant pharmaceutical plants outside of the ...

Lupin gains 2%, hits 52-week high; why pharma stock in focus?

Lupin management remains confident that the India formulations business will continue to outperform IPM by 1.2-1.3 times, supported by strong sales force and pipeline of new product launches.

India's drugmakers show fewer side effects under harsher USFDA scrutiny

USFDA data show OAI rates for Indian pharma plants falling to 8% by 2025 even as global outcomes worsen, reflecting stronger quality systems, technology adoption and compliance culture

Aurobindo Pharma up 3% in weak market, rebounds 6% from Wednesday's low

Aurobindo's management maintains confidence in achieving an internal EBITDA margin target of 20-21 per cent for FY26, supported by strong operating leverage and a diversified business model.

USFDA issues Form 483 with 4 observations for Piramal Pharma's T'gana plant

Piramal Pharma has said the US health regulator has issued Form 483 with four observations after inspecting its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) conducted an inspection of the company's Digwal (Telangana ) based plant from February 9, 2026, to February 13, 2026. At the conclusion of the inspection, the USFDA issued a Form-483, with four observations, Piramal Pharma said in a regulatory filing on Friday. These observations are related to enhancement in procedures and not related to data integrity and indicated to be classified as a VAI (voluntary action indicated), it added. The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines, the drug maker stated. Piramal Pharma remains committed to maintaining the highest standards of compliance and will work closely with the agency to comprehensively address all the observations, it added. As per the USFDA, Form 48

Aurobindo Pharma sinks 8%, stock hits over 3-month low post Q3 results

Aurobindo Pharma stock outlook: Eugia III resolution (in the backdrop of fresh observations) and the launch momentum across geographies would be key determinants, say analysts.

FDA to act against companies selling 'illegal copycat drugs', chief says

Makary's comments came after online telehealth company Hims and Hers Health began offering a much cheaper $49 compounded version of Novo Nordisk's new Wegovy weight-loss pill

Zydus Lifesciences gets US FDA approval for generic diabetes drug

Zydus Lifesciences on Wednesday has received approval from the US health regulator to market a generic diabetes drug in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg, the drug firm said in a statement. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The company said the tablets will be manufactured at its formulation manufacturing facility at SEZ, Ahmedabad. As per the industry estimates, Dapagliflozin tablets had annual sales of USD 10,486.9 million in the US. Zydus shares on Wednesday ended 0.23 per cent up at Rs 905 apiece on BSE.

Alembic Pharmaceuticals gets USFDA nod for generic eye treatment drug

Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic version of Difluprednate ophthalmic emulsion used to treat eye inflammation and pain due to surgery. The approval granted by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) Difluprednate ophthalmic emulsion of strength 0.05 per cent, Alembic Pharmaceuticals said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product, Durezol ophthalmic emulsion, 0.05 per cent, of Sandoz Inc, it added. Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery and also indicated for the treatment of endogenous anterior uveitis, a type of disorder of the eye.

Sun Pharma, Cipla recall products in US over manufacturing issues: USFDA

Drugmakers Sun Pharma and Cipla are recalling products in the US due to manufacturing related issues, according to the US Food and Drug Administration. As per its latest Enforcement Report, the US-based arm of Mumbai-based Sun Pharma is recalling over 26,000 bottles of a generic medication to treat dandruff and skin conditions with inflammation and itching. The Princeton (New Jersey)-based Sun Pharmaceutical Industries Inc is recalling 24,624 bottles of Fluocinolone Acetonide Solution Topical Solution for "Failed Impurities/Degradation Specifications", the US health regulator said. The company initiated the Class III nationwide (US) recall on December 30, 2025. The US Food and Drug Administration (USFDA) noted that the company is also recalling certain batches of a medication to treat acne vulgaris. Sun Pharmaceutical Industries Inc initiated the Class III recall of Clindamycin Phosphate USP on November 26, 2025 due to "Failed Impurities/Degradation: Out of Specification results f

FDA observation to hit Lanreotide supply; Cipla may face earnings risk

Cipla said supplies of its key US drug Lanreotide will remain constrained after its manufacturing partner paused production following USFDA observations

Cipla slips 5%, hits nine-month low; why pharma stock under pressure?

In the past seven trading days, the stock price of Cipla has slipped 11 per cent from ₹1,530.25 hit on January 1, 2026.

Popular weight-loss drugs shouldn't carry suicide warnings, FDA says

Federal regulators have told drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviours from their blockbuster weight-loss medications. The US Food and Drug Administration on Tuesday said a comprehensive review found no increased risk related to suicide among users of the GLP-1 drugs for obesity, including Novo Nordisk's Wegovy and Saxenda and Eli Lilly's Zepbound. A preliminary review in January 2024 showed no link between the drugs and suicidal thought or actions, the FDA said. At that time, however, officials said they could not rule out that a small risk may exist. The new analysis puts those concerns to rest. Labeling for other drugs known as GLP-1 receptor agonists approved to treat diabetes carried no such warnings, the agency noted. Today's FDA action will ensure consistent messaging across the labelling for all FDA-approved GLP-1 RA medications, officials said.

Granules India gets USFDA tentative nod for generic ADHD treatment tablets

Granules India Ltd on Thursday said its arm Granules Pharmaceuticals, Inc has received tentative approval from the US health regulator for its generic amphetamine extended-release tablets indicated for treatment of attention deficit hyperactivity disorder, with eligibility of 180-day exclusivity. The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amphetamine extended-release tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, Granules India Ltd said in a regulatory filing. These are the generic equivalent of DYANAVEL XR, it added. "The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercialising complex and differentiated generic products for the US market," the company said. The product is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and has an estimated market size of USD 41 ...

Indian pharma companies see sharp drop in adverse USFDA findings in 2025

OAI cases nearly halve in 2025, overall inspection volumes also fell 25%