"usfda"

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

Hyderabad: Close on the heels of securing DCGI’s approval for Canreal injection (generic version of Cangrelor) in India, Hyderabad-based MSN Laboratories, received tentative approval for generic version of Cangrelor from the USFDA. Cangrelor is an intravenously administered antiplatelet drug that is used at the time of cardiac surgery or percutaneous coronary intervention to decrease the […]

Hyderabad: A Nashik-based cancer diagnostic research facility Datar Cancer Genetics has announced that US Food and Drug Administration (FDA) has granted ‘breakthrough designation’ for its blood test to detect early-stage breast cancer. The proprietary diagnostic test, developed by the cancer genetics research facility, can ‘detect Circulating Tumor Cells and Clusters specific to Breast Cancer with very high […]

Hyderabad: Dr Reddy’s Laboratories received final approval of its Abbreviated New Drug Application (ANDA) from US Food and Drug Administration (USFDA) for Lenalidomide capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of Revlimid (lenalidomide). With this […]

Recently USFDA gave its nod for the use of Pfizer-BioNTech and Moderna Covid vaccines as additional dose on certain immunocompromised individuals

The use of high-grade face masks sees 100 per cent protection against direct, ward-based Covid-19 infection, says study

The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.

With herd immunity and a significant percentage of the US population vaccinated, the pandemic is reducing, and keeping this in view, the USFDA communicated that no new emergency use authorization would be approved for new Covid-19 vaccines

The company said the tablet is the bioequivalent and therapeutically equivalent to the Theophylline extended-release tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals Limited.

Quoting IQVIA sales data for the 12 month period ending April 2021, Glenmark Pharma said the Banzel tablets, 200 mg and 400 mg market achieved annual sales of approximately USD 285.3 million.

He also said that this is the time to invoke the compulsory licensing provisions in the law, so that a number of companies are able to produce the vaccines under a licence