Alembic Pharmaceuticals gets USFDA last endorsement for Doxycycline Hyclate Tablets Kumar Jeetendra | July 1, 2020 Alembic Pharmaceuticals has gotten last endorsement from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, 75 mg and 150 mg. The endorsed ANDA is remedially proportional to the reference recorded medication item (RLD), Acticlate Tablets, 75 mg and 150 mg, of Almirall, LLC. Doxycycline Hyclate …
Alembic Pharma gets USFDA’s’ speculative endorsement for type 2 diabetes DRUG Kumar Jeetendra | August 29, 2020 In a regulatory filing, Alembic Pharmaceuticals said it has received tentative approval by the US Food and Drug Administration (USFDA) for both Empagliflozin and Linagliptin pills in the strengths of 10 mg/5 mg and 25 mg/5 mg. Alembic Pharma stated it is now in litigation with Boehringer at District Court of Delaware and launch of …
Alembic Pharma gets USFDA gesture for bipolar depression drug Kumar Jeetendra | May 15, 2021 New Delhi, May 14 (PTI) Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Lurasidone Hydrochloride tablets, used to treat bipolar depression. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc. The company has received approval …
Alembic Pharma gets USFDA endorsement for anti-depressant drug Kumar Jeetendra | July 8, 2021 Drug firm Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Desipramine Hydrochloride tablets used in the treatment of depression. The approved product is therapeutically equivalent to the reference listed drug product Norpramin tablets of Validus Pharmaceuticals LLC. The company has received approval from the US Food and Drug …
Alembic Pharma gets last approval from USFDA for OCD treatment drug Kumar Jeetendra | August 5, 2021 New Delhi, Aug 5 (PTI) Drug firm Alembic Pharmaceuticals on Thursday said it has received final approval from the US health regulator for Clomipramine Hydrochloride capsules, used for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The company has received final approval from the US Food and Drug Administration (USFDA) for …
Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Final Approval for Mupirocin Cream USP, 2%. Kumar Jeetendra | November 20, 2021 17th November 2021, 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 Mupirocin Cream USP, 2%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), …
Alembic announces seed round investment in RIGImmune, Inc. Kumar Jeetendra | December 10, 2021 10th December, 2021, Mumbai: Alembic Pharmaceuticals Limited (Alembic) has announced today that it has made a strategic investment in RIGImmune Inc., a biopharmaceutical research company co-founded by two prominent Yale University professors. RIGImmune Inc. was founded by Dr. Anna Pyle and Dr. Akiko Iwasaki. Dr. Pyle is a Professor of Molecular, Cellular and Developmental Biology …
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 …
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 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 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 …
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 …
