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News about "Alembic Pharma"
Alembic Pharma Gets Tentative Approval for Olopatadine Hydrochloride Ophthalmic Solution
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 percent (OTC) has an estimated market size of USD 22 million for twelve months.
Alembic Pharma | 07/12/2024 | By Aishwarya
Alembic Pharma Gets FDA Approval for Lamotrigine Extended-Release Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK).
Alembic Pharma | 07/10/2024 | By Aishwarya | 101
Alembic Pharma Received FDA Approval for Fluphenazine Hydrochloride Tablets
Alembic Pharmaceuticals Ltd. has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.
Alembic Pharma | 25/07/2024 | By Aishwarya
Alembic Pharma Gets USFDA Tentative Approval for Selexipag for Injection
Alembic Pharmaceuticals has secured tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Selexipag for Injection, 1,800 mcg/vial.
Alembic Pharma | 15/07/2024 | By Aishwarya | 188
Alembic Pharma Gets USFDA Approval for Bromfenac Ophthalmic Solution
Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (USFDA) for its generic Bromfenac Ophthalmic Solution.
Alembic Pharma | 11/07/2024 | By Aishwarya | 148
Alembic Pharma Gets Tentative Approval from FDA for Ivosidenib Tablets
Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250 mg.
Alembic Pharma | 05/07/2024 | By Aishwarya | 204
Alembic Pharma Secures USFDA Tentative Approval for Bosutinib Tablets
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets, 100 mg and 500 mg.
Alembic Pharma | 02/07/2024 | By Aishwarya | 276
Alembic Pharma receives EIR from US FDA for solid oral formulation facility at Jarod
The inspection carried out by them at our Solid Oral Formulation Facility (F-4) at Jarod, Vadodara during the period from December 6 to 16, 2022
Alembic Pharma | 11/05/2023 | By Sudeep Soparkar | 411
Generic Pradaxa Capsules from Alembic Pharma given tentative approval by the US FDA
Alembic Pharmaceuticals Limited has gotten speculative endorsement from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for dabigatran etexilate cases, 75 mg, 110 mg, and 150 mg.
Alembic Pharma | 08/04/2022 | By Sudeep Soparkar | 640
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