SEC suggests Covid-19 immunization Corbevax for 12 to 18 year age group: Report Kumar Jeetendra | February 15, 2022 The Drugs Controller General of India (DCGI)’s Subject Expert Committee (SEC) has recommended Emergency Use Authorization to Hyderabad-based pharmaceutical company Biological E’s COVID-19 vaccine, Corbevax, for the age group 12 to 18 years subject to certain conditions, official sources said. The country’s central drug authority is expected to give final approval to Corbevax, which is …
Alembic Pharmaceuticals receives USFDA Tentative Approval for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. Kumar Jeetendra | February 2, 2022 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 …
Alembic Pharmaceuticals receives USFDA Final Approval for Clarithromycin Tablets USP, 250 mg and 500 mg. Kumar Jeetendra | February 1, 2022 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Clarithromycin Tablets USP, 250 mg and 500 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Biaxin Filmtab Tablets, 250 mg and 500 …
Glenmark Pharma arm gets last USFDA endorsement for blood pressure drug Kumar Jeetendra | January 27, 2022 Glenmark Pharmaceuticals Ltd announced that its U.S. subsidiary received final approval by the country’s regulator for generic Bisoprolol fumarate and Hydrochlorothiazide tablets to treat high blood pressure. According to a statement, Glenmark Pharmaceuticals Inc., U.S.A was granted approval for Bisoprolol Fumarate tablets in strengths of 2.5 mg/6.25mg, 5 mg/6.25mg, and 10 mg/6.25 MG. These generic …
Glenmark Pharma gets conditional USFDA nod for generic Regadenoson injection Kumar Jeetendra | January 21, 2022 Glenmark Pharmaceuticals on Monday said its US arm has received tentative approval from the country’s health regulator for its generic Regadenoson injection. Regadenoson injection is given during the preparation for a radiologic examination of blood flow through the heart to test for coronary artery disease. According to a statement, the tentative approval was granted by …
Cipla to Present at the 40th Annual J.P. Morgan Healthcare Conference Kumar Jeetendra | January 12, 2022 India; January 12, 2022: Cipla Limited (BSE: 500087; NSE: CIPLA EQ) referred to as “Cipla” today announced that it will participate at the 40th Annual J.P. Morgan Healthcare Conference, which is the largest healthcare investment symposium in the industry. Mr. Umang Vohra, MD and Global CEO, Cipla, will virtually present a corporate overview of the …
Indica Labs’ HALO AP® platform achieves CE-IVD certification for use in primary diagnosis Kumar Jeetendra | January 10, 2022 Albuquerque, NM, 10 January, 2022 – Life Science Newswire – Indica Labs, a leading provider of computational pathology software and services, is proud to announce that following ISO13485 certification, HALO AP® has received a CE Mark for use in primary diagnosis within the European Economic Area, Switzerland, and the UK. The HALO AP platform was …
Alembic Pharmaceuticals receives USFDA Tentative Approval for Dronedarone Tablets USP, 400 mg. Kumar Jeetendra | January 10, 2022 10th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dronedarone Tablets USP, 400 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Multaq Tablets, 400 mg, …
Alembic Pharmaceuticals receives USFDA Tentative Approval for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. Kumar Jeetendra | January 7, 2022 7th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug …
Alembic Pharmaceuticals receives USFDA Final Approval for Entacapone Tablets USP, 200 mg. Kumar Jeetendra | January 6, 2022 6th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Entacapone Tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets, 200 mg, of …
Alembic Pharmaceuticals receives USFDA Final Approval for Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg. Kumar Jeetendra | January 4, 2022 4th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg. The approved ANDA is therapeutically equivalent to the reference …
Emcure Pharma to launch oral Covid-19 drug in a week Kumar Jeetendra | January 2, 2022 Emcure Pharmaceuticals Ltd (EPL) reported that it received an emergency Use Authorisation (EUA) approval from the Drug Controller General of India for the introduction of Molnupiravir the oral anti-viral that is under investigation, to treat mild COVID-19. EPL plans to launch this drug with the name Lizuvira on India. Indian market. “As the need for …
