USFDA

The successful closure of the inspection further strengthens Strides' regulatory track record and reinforces the company's commitment to supplying high-quality pharma products to patients across globe

Biocon Ltd on Tuesday said its subsidiary has received supplemental approval from the US health regulator for Yesintek prefilled autoinjector. Yesintek is indicated for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis. The company's subsidiary in the United States has received supplemental US Food and Drug Administration (USFDA) approval for Yesintek of strengths 45 mg/0.5 ml single-dose prefilled autoinjector and 90 mg/ml single-dose prefilled autoinjector, Biocon said in a regulatory filing. Yesintek was originally approved by the USFDA on November 29, 2024, it added. The Yesintek single-dose prefilled autoinjector offers patients with another important treatment option. This new delivery format supports more tailored treatment approaches across different care settings and patient needs, the company said. Yesintek is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients

Aurobindo Pharma on Friday said the US health regulator has issued a warning letter to a formulation manufacturing facility of its arm, Eugia Pharma Specialities Ltd, in Telangana. In May this year the company had stated that the US Food and Drug Administration (USFDA) inspected Unit-I, a formulation manufacturing facility of Eugia Pharma Specialities Ltd located at Telangana from February 16 to February 27, 2026. The inspection had concluded with four observations and the USFDA had determined the facility as 'official action indicated' (OAI). "Subsequent to OAI, the unit has received a warning letter," Aurobindo Pharma said in a regulatory filing. There is no impact on the existing supplies to the US markets, it added. The company further said the Unit I of Eugia Pharma Specialities Ltd, is contributing to about 2 per cent to company's overall group revenue. Aurobindo Pharma said it remains committed to working closely with the US FDA and continues to enhance its compliance on a

Molbio Diagnostics plans to expand its overseas business through subsidiary OptraScan after the latter secured USFDA clearance, while diversifying beyond tuberculosis-focused public-health revenues.

The US Food and Drug Administration (USFDA) has issued a warning letter to home-grown FMCG major Dabur India citing significant violations of current good manufacturing practices (CGMP) at its pharmaceutical manufacturing facility in Silvassa. The warning letter follows an inspection conducted by the US health regulator at the company's facility in Silvassa, Dadra and Nagar Haveli and Daman and Diu, from January to December 16, 2026. USDFA, in its letter dated July 24, 2027, to Dabur India CEO Mohit Malhotra, has pointed out data integrity lapses, inadequate quality oversight and deficient manufacturing controls. According to the USFDA, the facility's methods, controls and manufacturing practices did not conform to CGMP requirements, resulting in the products being considered "adulterated" under the US Federal Food, Drug and Cosmetic Act. Among the most serious findings, the USFDA said its investigator discovered that an equipment usage logbook provided by the company for a ...

USFDA has granted final approval to Zydus Lifesciences' generic version of IC-Green, an imaging agent used in vascular, transplant and cancer surgeries.

Share price of Rubicon Research hit a new high of ₹1,545.60, rallying 6 per cent on the BSE in Thursday's intra-day deals in an otherwise weak market.

Glenmark Pharmaceuticals on Monday announced the launch of the generic version of Olanzapine injection, indicated for treatment of schizophrenia and bipolar disorder, in the US. The company's arm Glenmark Pharmaceuticals Inc, USA has launched Olanzapine for injection of strength 10 mg/vial, single-dose vial, Glenmark said in a regulatory filing. The company's Olanzapine for injection is bioequivalent and therapeutically equivalent to the reference listed drug, Zyprexa intramuscular injection 10 mg/vial, of Cheplapharm Registration GmbH, it added. "The launch of Olanzapine for Injection underscores our strategic focus on growing a robust injectables portfolio and strengthening our presence within the institutional channel," Glenmark President & Business Head, North America, Marc Kikuchi said. Citing IQVIA sales data for the 12-month period ended May 2026, Glenmark said the Zyprexa intramuscular injection market achieved annual sales of approximately USD 25.4 million.

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 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.

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.

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

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

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

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

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

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

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 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 .

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