"usfda"

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 […]

New Delhi: Dr Reddy’s Laboratories on Tuesday said it has launched Sorafenib tablets, used in the treatment of various cancers, in the US market after getting approval from the US Food and Drug Administration (USFDA). “We are pleased to launch this important generic product, illustrating our continued commitment to bring affordable generic medicines to market […]

Hyderabad: Hyderabad-based vaccine maker Biological E Limited (BE) has priced its Corbevax, which has got approval for administration to adolescents aged 12 to 14 years, at Rs 800 (excluding GST) per dose for the private market, and Rs 145 per dose for the government, making it the cheapest vaccine in India and also globally, the […]

Hyderabad: India needs diplomatic channels created by the government towards USFDA, EU or Japan to really work with regulatory agencies. There is not much pharma business happening with Japan despite India’s friendly relationship with them because of the regulatory framework, say industry experts. “There is much more than funding that government has to do on […]

Hyderabad: Hyderabad-based Granules India said the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI), a wholly owned foreign subsidiary of the company, for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg. It is bioequivalent to the reference listed drug […]

New Delhi: Aurobindo Pharma on Friday said it has received a warning letter from the US health regulator for its Hyderabad-based Unit I, an API (active pharmaceutical ingredient) manufacturing facility. The action follows the recent inspection of the facility by the US Food and Drug Administration (USFDA) in August 2021, the drugmaker said in a […]