Fda

US recalls 2.5 mn bottles of India-made eye drops after contamination scare

The US Food and Drug Administration (FDA) said the recall was started because of the potential presence of a foreign substance in the eye drops

Glenmark launches generic schizophrenia, bipolar disorder drug in US

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.

Zaynich antibiotic: How Wockhardt created India's first FDA-approved drug | Pharma Industry

For decades, India excelled at making affordable generic medicines. But creating a brand-new drug from scratch remained a rare achievement. Now, Wockhardt has made history with Zaynich

Maha FDA: Hospitals can't force patients to buy drugs from own pharmacies

The state regulator has directed hospitals and doctors to provide prescriptions directly to patients and allow them to buy medicines from any licensed pharmacy

Wockhardt eyes $1.5 bn peak sales from Zaynich, targets US launch by yr-end

Novel antibiotic to be launched in India around the same time; company to commercialise product on its own in US

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

Zydus eyes Q4 FY27 US launch for liver disease drug after FDA review

The US FDA has granted priority review to Saroglitazar, Zydus Lifesciences' drug for treating Primary Biliary Cholangitis

Eli Lilly backs Haryana FDA action on counterfeit Mounjaro seizures

Pharma major says seized fake Mounjaro in Gurugram did not originate from its supply chain, urges vigilance and purchase only through authorised channels

Orbicular Pharma gets US FDA nod for generic Ozempic with Apotex

Orbicular Pharma and Apotex secure tentative US FDA approval for generic Ozempic, marking entry into fast-growing semaglutide market pending patent clearance

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 ...

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

Maharashtra FDA cancels 13 licences, suspends 32 medical stores in Nanded

The Maharashtra Food and Drug Administration (FDA) has cancelled the licences of 13 medical stores and suspended those of 32 in Nanded district over alleged sale of intoxicant tablets, officials have said. As part of a drive, the FDA had issued show-cause notices to 48 medical stores for selling intoxicant tablets without a doctor's prescription and for violating the Drugs and Cosmetics Act, Assistant Commissioner (Drugs) AT Rathod said in a release on Wednesday. After the explanations submitted were found unsatisfactory, the licences of 32 medical stores were suspended, while the licences of 13 stores were permanently cancelled. Action has been proposed against the remaining three medical stores, it said. In some cases, the FDA said, the medical stores have secured stay orders at the government level, and proceedings against them are currently pending before higher authorities.

Biocon arm Syngene eyes late-stage clinical supplies amid regulatory shift

As regulators ease biosimilar trial norms, Syngene International is expanding into late-stage clinical supply production, betting on biologics and peptide manufacturing for growth

FDA's top drug regulator resigns after officials probe 'serious concerns'

The head of the Food and Drug Administration's drug centre abruptly resigned on Sunday after federal officials began reviewing serious concerns about his personal conduct, according to a government spokesperson. Dr George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services' Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned on Sunday morning. Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency, Hilliard said. The departure came the same day that a drugmaker connected to one of Tidmarsh's former business associates filed a lawsuit alleging that he made false and defamatory statements during his time at the FDA. The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a longstand

Biocon Biologics expands diabetes portfolio with FDA approval for Kirsty

Interchangeable biosimilar to NovoLog in the US and will be available in prefilled pens and vials

Price pressures to intensify for drugmakers, says Sun Pharmaceutical

Sun Pharma expects global pricing strain due to policy shifts, as FY25 US sales rise 5.8% despite compliance challenges; specialty business lifts overall growth

Blinkit, Zepto resume operations in Maharashtra after FDA licence clearance

Blinkit and Zepto resume operations at closed facilities in Maharashtra after securing food safety licences and complying with corrective actions ordered by the FDA

Govt to increase checks on quick commerce dark stores amid hygiene issues

FSSAI to lead surprise inspections as complaints about poor hygiene and expired products in dark stores mount; packaged food brands urge quick commerce platforms to improve standards

Maharashtra FDA orders closure of Blinkit dark store amid licence issues

Blinkit's Balewadi dark store ordered closed by Maharashtra FDA for lack of food licence and unhygienic conditions amid rising scrutiny of quick commerce platforms

Zepto's food business licence cancelled in Dharavi over 'poor hygiene'

Maharashtra FDA suspends Zepto's food business licence in Dharavi after inspection reveals severe hygiene violations and non-compliance with food safety norms