Alembic Pharmaceuticals receives USFDA Tentative Approval for Ivabradine Tablets, 5 mg and 7.5 mg. Kumar Jeetendra | April 20, 2022 20th April 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 Ivabradine Tablets, 5 mg and 7.5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, …
Alembic Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. Kumar Jeetendra | April 12, 2022 12th April 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. The approved ANDA is therapeutically equivalent to the reference listed …
Alembic Pharmaceuticals announces USFDA Tentative Approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. Kumar Jeetendra | April 7, 2022 7th April, 2022, Mumbai: Alembic Pharmaceuticals Limited today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) …
Inhalation Sciences signs IRS contract worth 491,000 SEK with returning nanotechnology client Kumar Jeetendra | April 1, 2022 A leading nanotechnology company has returned to carry out another research project with Inhalation Research Services (IRS), ISAB’s contract research organization. The previous project, worth 584,000 SEK, began in February 2022. The new project, worth 491,000 SEK, will test slightly different versions of the company’s porous inhalable nanoparticles. Further studies with the same client are …
Alembic pharmaceuticals acquires 100% stake in Aleor Dermaceuticals Kumar Jeetendra | March 29, 2022 Alembic Pharmaceuticals Limited (“Alembic” or “the Company”) has acquired the balance 40% stake in Aleor Dermaceuticals Limited (“Aleor”) from its JV Partner Orbicular Pharmaceutical Technologies Private Limited (“Orbicular”) to strengthen its skin-related manufacturing and marketing footprint. Aleor has product offerings across Cream, Gel, Ointment, Shampoo, Lotion, Solutions, Sprays, Foams, Microsponge and Nanoparticulate platform-based products. The …
Alembic Pharmaceuticals receives USFDA Tentative Approval for Macitentan Tablets, 10 mg. Kumar Jeetendra | March 14, 2022 14th March 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 Macitentan Tablets, 10 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Opsumit Tablets, 10 mg, of …
Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Final Approval for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram. Kumar Jeetendra | March 8, 2022 8th March 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram. The approved ANDA is therapeutically equivalent to the reference …
Dr. Robert Califf has been declared as chief of the Food and Drug Administration Kumar Jeetendra | February 16, 2022 The Senate on Tuesday narrowly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration an important federal agency without a permanent leader since the whole year time during the coronavirus outbreak. The vote was 50-46with six Republicans who voted across the aisle to back the senator, and five Democrats were against him. …
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 …
