Alembic Pharma Gets USFDA Approval for Divalproex Sodium Capsules, 125 mg Kumar Jeetendra | December 20, 2024 Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc. Alembic …
Alembic Pharma Gets USFDA Nod for Rivaroxaban Tablets Kumar Jeetendra | May 15, 2025 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) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 …
Alembic Pharma Gets USFDA Nod for Amlodipine-Atorvastatin Tablets Kumar Jeetendra | May 23, 2025 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) Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 …
Alembic Gets USFDA Nod for Doxorubicin Liposome Injection Kumar Jeetendra | June 30, 2025 30th June, 2025 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 Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent …
Alembic Pharma Gets USFDA Nod for Ticagrelor 60 mg Tablets Kumar Jeetendra | November 1, 2025 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) Ticagrelor Tablets, 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Ticagrelor tablets are …
Alembic Gets USFDA Nod for Sumatriptan Injection Autoinjector Kumar Jeetendra | November 10, 2025 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) Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Imitrex STATdose System, …
Alembic Pharma Gets USFDA Nod for Diltiazem HCl Tablets Kumar Jeetendra | November 17, 2025 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) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 …
Alembic Pharma Wins USFDA Approval for Dapagliflozin Tablets Kumar Jeetendra | April 7, 2026 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) Dapagliflozin Tablets, 5 mg and 10 mg. Alembic Pharmaceuticals Limited Gets USFDA Approval for Dapagliflozin Tablets The approved ANDA is therapeutically equivalent to the reference listed drug product …
Alembic Pharma Receives USFDA Approval for Haloperidol Tablets Kumar Jeetendra | June 5, 2026 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) Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Haldol …
Cipla Receives U.S. FDA Approval for Generic Advair Diskus® Kumar Jeetendra | July 28, 2026 Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) and its wholly owned subsidiary Cipla USA Inc., (hereafter referred to as “Cipla”), today announced that Cipla Limited has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Generic Advair Diskus® (fluticasone propionate and salmeterol …
