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 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) …
Alembic Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Clobetasol Propionate Foam, 0.05%. Kumar Jeetendra | April 28, 2022 25th 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 Clobetasol Propionate Foam, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product …
Alembic Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Docosanol Cream, 10% (OTC) Kumar Jeetendra | May 4, 2022 4th May 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 Docosanol Cream, 10% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product …
Alembic Pharmaceuticals receives USFDA Final Approval for Pirfenidone Tablets, 267 mg and 801 mg. Kumar Jeetendra | May 25, 2022 24 May 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 Pirfenidone Tablets, 267 mg and 801 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Esbriet Tablets, 267 …
Alembic Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Diclofenac Sodium Topical Gel, 3%. Kumar Jeetendra | August 1, 2022 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 Diclofenac Sodium Topical Gel, 3%.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze Topical Gel, …
Aleor Dermaceuticals Limited receives USFDA Final Approval for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. Kumar Jeetendra | August 8, 2022 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 Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) …
Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets USP, 25 mg and 50 mg. Kumar Jeetendra | August 29, 2022 29th August 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 Chlorthalidone Tablets USP, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, …
Alembic Pharmaceuticals receives USFDA Final Approval for Paclitaxel Injection USP Kumar Jeetendra | October 27, 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 Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials. This is the first product approval …
Alembic Pharmaceuticals’ Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, gain USFDA approval. Kumar Jeetendra | January 6, 2023 06th January 2023, 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), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toviaz Extended-Release …
Alembic Pharmaceuticals gets USFDA tentative approval for 100 mg Acalabrutinib capsules. Kumar Jeetendra | January 20, 2023 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), Acalabrutinib Capsules, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited (AstraZeneca). Acalabrutinib Capsules are …
Alembic Pharmaceuticals announces USFDA Final Approval for Docetaxel Injection USP Kumar Jeetendra | March 1, 2023 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) Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials. The approved ANDA is therapeutically …
