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Cefdinir for Oral Suspension (250 mg/5 mL) being recalled due to “defective container: lack of seal integrity”, says USFDA
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The string of ban announcements underscores the urgent need for India to enhance its food safety protocols
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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).
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In the financial year 2022-23, 258 USFDA units were approved in Telangana, much higher than the 199 units in New Jersey.
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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.
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At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added.
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The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.
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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
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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. […]
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
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Hyderabad: MSN Group, a Hyderabad-based pharma company, is all set to launch the generic molnupiravir 200 mg capsules for treating Covid-19 under the brand name Moluflow. Molnupiravir is an oral Covid-19 antiviral medicine indicated for the treatment of mild-to-moderate Covid-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk […]
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Hyderabad: Dr Reddy’s Laboratories said on Tuesday the company will launch its molnupiravir capsules 200mg under its brand name Molflu across India. The drug will be priced at Rs 35 per capsule with 10 capsules contained per strip, and the total course of 40 capsules over five days costing Rs 1,400. Molflu is expected to […]
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Hyderabad: Granules Pharmaceuticals Inc (GPI), a wholly owned foreign subsidiary of Hyderabad-based Granules India, received the US Food & Drug Administration (US FDA) approval for the Abbreviated New Drug Application (ANDA) for Prazosin Hydrochloride Capsules, USP 1mg, 2mg and 5mg. It is bioequivalent to the reference listed drug product (RLD), Mini plus capsules 1Mg, 2Mg […]
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Hyderabad: MSN Pharmaceuticals Inc. (MSNPI), a wholly owned subsidiary of Hyderabad-based MSN Group of companies, based out of Piscataway, New Jersey, USA completed its maiden USFDA audit with zero observations. The finished dosages facility was established to enhance MSN Group’s product portfolio as well as contract development & manufacturing services, in the US and several […]
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New Delhi: Drug firm AstraZeneca on Friday said that a preclinical study has concluded that its antibody combination Evusheld for the prevention of coronavirus infection has been found to have retained neutralising activity against the Omicron variant. The study was done independently by investigators at the US Food and Drug Administration (USFDA), Center for Biologics […]