Usfda

Nifty Pharma rallies 2%; Laurus, Ipca, Aurobindo, Torrent hit record highs

In the past month, the Nifty Pharma index outperformed the market by surging 7.4 per cent, as compared to 4.2 per cent rise in the Nifty 50.

Alembic Pharmaceuticals gets USFDA nod for generic acne treatment gel

Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for the generic version of Dapsone gel indicated for the topical treatment of acne vulgaris. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dapsone gel, 5 per cent, Alembic Pharmaceuticals said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product Aczone Gel, 5 per cent of Almirall, LLC, it added. Dapsone gel is indicated for the topical treatment of acne vulgaris, the company said.

Nifty Pharma index up 2%; Dr Reddy's, Ajanta, Ipca, Cipla surge up to 5%

In the past seven trading days, the Nifty Pharma index outperformed the market by soaring 5.4 per cent, as compared to 0.1 per cent decline in the Nifty 50.

Alembic Pharma gets USFDA nod for drug to treat influenza A and B in babies

The drug that has received the final approval from the US regulatory body is Oseltamivir Phosphate for Oral Suspension, 6 mg/mL

Alembic Pharma gets tentative approval from USFDA for generic cancer drug

Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic version of cancer treatment drug Binimetinib tablets. The tentative approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Binimetinib tablets of strength 45 mg, Alembic Pharmaceuticals said in a regulatory filing. Based on USFDA's paragraph IV certifications list, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg and upon final approval of this ANDA by the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the US, the company said. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg, it added. Binimetinib in combination with encorafenib is used for the treatment of patients with unresectable or metastatic melanoma with resistance to specific targeted therapies in cancer. It is also indicated, in combination

Cipla expands respiratory, specialty manufacturing across India, China, US

Filed 10 applications with USFDA in FY26 to build a pipeline of differentiated products for regulated markets

Revlon fails to ensure some products are safe, warns US regulator

The Food and Drug Administration called one Revlon product higher risk because of its potential to be contaminated with a known human carcinogen in the letter dated June 2

New launches, India business growth key triggers for Zydus Lifesciences

Strong domestic growth, an expanding specialty portfolio, acquisitions and a robust product pipeline are expected to support Zydus Lifesciences' performance in FY27

Wockhardt soars 19%, zooms 75% in 1 month; what's driving pharma stock?

Wockhardt recently received USFDA approval for Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for treating complicated urinary tract infections, including pyelonephritis, in adults.

US FDA flags data integrity, maintenance lapses at Dabur India plant

Dabur ​is one of India's oldest and largest consumer goods companies, describing itself ‌as one of the world's largest suppliers of Ayurvedic products with a legacy of over 140 years

Alembic Pharma gets USFDA nod for generic levothyroxine sodium tablets

Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic version of levothyroxine sodium tablet indicated as a replacement therapy for hypothyroidism. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of levothyroxine sodium tablets of strengths 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg, Alembic said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product, Synthroid tablets, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg, of AbbVie, Inc, it added. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism, the company said. Levothyroxine sodium tablets are indicated as .

Donald Trump planning to fire FDA Commissioner Marty Makary: Report

Makary, a surgical oncologist at the Johns Hopkins University School of Medicine, was confirmed as FDA commissioner in March 2025

Cipla gets USFDA nod for respiratory issues treatment inhalation aerosol

Pharma major Cipla Ltd on Thursday said it has received final approval from the US health regulator for its generic version of albuterol sulfate inhalation aerosol indicated for the treatment or prevention of bronchospasm. The final approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Albuterol sulfate inhalation aerosol of strength 90 mcg per actuation, Cipla said in a regulatory filing. It is the first AB-rated generic therapeutic equivalent of Ventolin HFA, marketed by GlaxoSmithKline, it added. Commenting on the approval, Cipla Managing Director and Global CEO Achin Gupta said, "This marks an important milestone for Cipla and reflects our strong scientific and regulatory capabilities in complex inhalation products." He further said, "Lung health remains at the heart of all our offerings and follows a singular, distilled objective, to build a sustainable and differentiated portfolio for patients globally." Albuter

USFDA flags 3 manufacturing compliance lapses at Lupin's New Jersey unit

Pharma major Lupin Ltd on Saturday said the US health regulator has issued Form 483 with three observations to its Somerset, New Jersey, facility in the US following an inspection. The USFDA has concluded the inspection at our manufacturing facility located in Somerset, New Jersey, USA, Lupin said in a regulatory filing. "The inspection was conducted from April 13, 2026, to April 17, 2026, and closed with the issuance of a Form-483 with three observations," it added. The company further said, "We will address the observations and respond to the USFDA within the stipulated timeframe". Lupin said it is "committed to be compliant with CGMP standards across all our facilities". According to 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.

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 ...