"usfda"

Glenmark Pharmaceuticals received US Food and Drug Administration approval for generic progesterone vaginal inserts, equivalent to Endometrin, boosting its women’s healthcare portfolio and expanding presence in the US fertility treatment market

Indian-American scientist Vinay Prasad has stepped down for the second time as director of the FDA’s Center for Biologics Evaluation and Research within a year. His tenure saw record approvals but also sharp disputes with pharmaceutical companies, including Moderna and UniQure, over trial standards.

Alembic Pharmaceuticals has received final approval from the USFDA for its Lamotrigine orally disintegrating tablets used in the treatment of various seizure disorders.

The USFDA issued a warning to Telangana’s Palamur Biosciences for serious Good Laboratory Practice violations, citing inhumane animal treatment and unreliable data. PETA India has urged government intervention, demanding rescue of 1,200 animals and reform of India’s experimentation regulator

Cyberabad Cyber Crime Police arrested two persons for orchestrating a cyber-extortion racket against the Hetero Group of Companies. The accused impersonated USFDA officials through fake emails, demanding USD 250 million and threatening regulatory action with forged documents.

Dr Reddy’s received a Form 483 with seven USFDA observations after inspecting its Srikakulam manufacturing plant in Andhra Pradesh

The drug-maker is recalling India-produced Metoprolol Succinate extended-release tablets in 100 count and 500 count bottles in US

US-based unit of the drug major is recalling Acetaminophen Tablets (325 mg) in the US due to cGMP (Current Good Manufacturing Practices) deviations

As per its latest Enforcement Report, USFDA said a US-based subsidiary of the Hyderabad-based drug major is recalling certain batches of a generic antiepileptic drug in the US market.

Hyderabad based Natco pharma and its associate Lupin Limited got yet another US FDA approval for manufacture of Bosentan tablets

Cefdinir for Oral Suspension (250 mg/5 mL) being recalled due to “defective container: lack of seal integrity”, says USFDA

The string of ban announcements underscores the urgent need for India to enhance its food safety protocols

Aparna Pharmaceuticals, part of the Aparna Group, has announced that its manufacturing facility, Aparna Organics Limited in Pydibhimavaram, Srikakulam, Andhra Pradesh, India, has attained VAI classification from the US Food and Drug Administration (USFDA).

In the financial year 2022-23, 258 USFDA units were approved in Telangana, much higher than the 199 units in New Jersey.

The pharma firm had approached the Drugs Controller General of India (DCGI)seeking a waiver for the phase-III clinical trial of the drug and its market authorisation.

At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.

Dr Reddy's Laboratories reduced the price of its cardiovascular drug Cidmus, MSN Group, launched the world’s first generic Palbociclib tablets for advanced breast cancer therapy

Despite the rapid development of modern technology and high-end research in the field of medicine, an effective cure or treatment for cancers continues to remain elusive for scientists, researchers, clinicians and patients. While high-end diagnostics and treatment tools are available, a majority of cancer patients, however, continue to struggle with side effects and poor prognosis. […]

Hyderabad: It takes at least a decade or even more to develop and launch a novel drug from a ‘bench to bedside’ in India. By the time the drug reaches the patients after the initial discovery, drug developers would have already burned through a substantial chunk of financial investment, human resources and above all, decades […]