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 …
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 …
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 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 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 …
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 announces USFDA Final Approval for Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial Kumar Jeetendra | May 11, 2022 11 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 Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), …
Cipla scored highest among pharma companies in CRISIL’s Sustainability Rating 2022 Kumar Jeetendra | May 25, 2022 Mumbai, India; May 25, 2022: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) announced today that is has been rated ‘STRONG’ in the Sustainability Yearbook 2022 released by CRISIL, a leading rating agency in India. Based on the fiscal 2021 data, CRISIL analysed 586 companies across 53 sectors for over …
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 …
