USFDA

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.

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

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 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 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.

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

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

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.

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 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 ...

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

The USFDA said the affected batch of Taro shampoos failed to meet impurity or degradation specifications

Drug firm Granules India on Monday said it has received approval from the US health regulator to market a generic medication for attention deficit hyperactivity disorder. Granules Pharmaceuticals Inc, a wholly-owned subsidiary of the company, has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine extended-release orally disintegrating tablets in multiple strengths, the company said in a statement. The company's product is the generic equivalent of Adzenys XR-ODT, it added. The product will be manufactured at Granules' US-based facility located in Chantilly, Virginia. The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of around USD 172 million according to IQVIA (IMS Health). Currently, the market has only one approved generic and one authorised generic, positioning Granules favourably to expand access to this crit

Aurobindo Pharma on Thursday said the US health regulator has issued a Form 483 with five observations after inspecting Andhra Pradesh-based Unit-IV of its subsidiary APL Healthcare. The US Food and Drug Administration (USFDA) inspected the unit from December 8 to December 17, 2025, the Hyderabad-based drug firm said in a regulatory filing. "At the end of the inspection, a 'Form 483' was issued with 5 observations which are procedural in nature, and we will respond to the US FDA within the stipulated timelines," it added. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, the drug firm said. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Shares of Aurobindo Pharma were trading 0.83 per ..

The drug, CUTX-101, is intended for the treatment of Menkes disease, a rare X-linked recessive genetic disorder affecting male children

A black box warning is the strongest caution for prescription drugs and is usually reserved for alerting patients to possible adverse reactions that could lead to death or serious injury

Alembic Pharmaceuticals Ltd on Thursday said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection. The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing. Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5 per cent/0.3 per cent, of Bausch & Lomb Incorporated, the company said. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5 per cent/0.3 per cent, is ...

Till 01:44 PM; as many as a combined 27.7 million equity shares representing 8.5 per cent of the total equity of pharmaceutical company have changed hands on the NSE and BSE.

The company said the United States Food and Drug Administration (USFDA) has formally accepted the New Drug Application (NDA) for its first-in-class antibiotic 'Zaynich'