Natco Pharma’s’ gets USFDA endorsement for Visakhapatnam plant Kumar Jeetendra | April 28, 2020 Natco Pharma today declared that it has gotten a last endorsement for its first supplemental condensed new medication application (ANDA) item from US Food and Drug Administration (USFDA) documented from its new medication plan office in JNPC SEZ, Ramky Pharma City, Visakhapatnam (Andhra Pradesh). ANDA, submitted as ‘earlier endorsement supplement’, accommodates NATCO’s Visakhapatnam office as …
Glenmark Pharma propels on USFDA gesture for Qtern generic Kumar Jeetendra | April 29, 2020 Glenmark Pharmaceuticals rose 1.43% to Rs 332.50 after the medication producer said it got conditional contracted new medication application (ANDA) endorsement for Dapagliflozin and Saxagliptin tablets in 10 mg/5 mg qualities. Glenmark Pharmaceuticals Inc., USA (Glenmark) has been conceded conditional endorsement by the United States Food and Drug Administration (USFDA) for Dapagliflozin and Saxagliptin tablets, …
Aurobindo Pharma gets USFDA gesture for Flucytosine Capsules Kumar Jeetendra | May 4, 2020 Aurobindo Pharma Limited has gotten last endorsement from the US Food and Drug Administration (USFDA) to make and market Flucytosine Capsules, 250 mg and 500 mg. Flucytosine Capsules are conventional adaptation of Bausch Health’s Ancobon® Capsules. The item will be propelled in June 2020. The endorsed item has an expected market size of US$ 43 …
Cipla receives final approval for generic version of Migranal® Kumar Jeetendra | May 21, 2020 Mumbai, India; May 21, 2020: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (“ANDA”) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U.S. FDA) with a Competitive Generic Therapy (“CGT”) …
Glenmark Pharmaceuticals gets endorsement from USFDA to advertise conventional medication for muscle torment in American market Kumar Jeetendra | May 27, 2020 Glenmark Pharmaceuticals on Wednesday said its auxiliary has gotten endorsement from the US wellbeing controller to advertise Chlorzoxazone tablets, used to treat muscle torment, in the American market. Glenmark Pharmaceuticals Inc, USA has been conceded last endorsement by the US Food and Drug Administration (USFDA) for Chlorzoxazone tablets USP, in the quality of 375 mg …
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), …
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 announces USFDA Final Approval for Fluorouracil Injection USP Kumar Jeetendra | March 6, 2023 Alembic Pharmaceuticals Limited (Alembic) today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the Reference Listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 …
