Alembic Pharmaceuticals

RegulatoryJune 19, 2026

Alembic's ANDA215230 for Brimonidine Tartrate and Timolol Maleate Receives AP Status

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of AP for Alembic's formulation of Brimonidine Tartrate and Timolol Maleate.

Recent signals(20)

FDA Grants Approval for Prucalopride Succinate ANDA219234 by Alembic

FDA Approves Fingolimod Hydrochloride Application by Alembic

FDA Grants Approval for Methotrexate Sodium by Alembic

FDA Approval Process Update for Lamotrigine by Alembic Pharmaceuticals

FDA Grants Approval for Doxycycline Hyclate ANDA210527 by Alembic

FDA Accepts Supplement Application for Celecoxib by Alembic

Alembic's Methotrexate Sodium ANDA217552 Receives AP Status from FDA

FDA Grants Approval for Levothyroxine Sodium ANDA216370 by Alembic

Alembic Pharmaceuticals submits ANDA220499 for FDA review

Alembic's ANDA207974 for Fingolimod Hydrochloride Receives Approval

Alembic's Methotrexate Sodium ANDA220225 Receives AP Status from FDA

FDA Approves Lamotrigine Supplement from Alembic Pharmaceuticals

FDA Approves Dapsone ANDA213414 by Alembic

Alembic's Oseltamivir Phosphate ANDA Submission Receives AP Status

FDA Grants Approval for Haloperidol ANDA214470 by Alembic

FDA Acceptance of Binimetinib Application by Alembic Pharmaceuticals

Alembic's ANDA215230 for Brimonidine Tartrate and Timolol Maleate Receives AP Status

Alembic submits ANDA for Bosutinib Monohydrate

FDA Grants Approval for Tretinoin ANDA214590 by Alembic

Alembic Pharmaceuticals Submits ANDA220639 for Review

Upcoming catalysts

Regulatory activity(7)

FDA Grants Approval for Methotrexate Sodium by Alembic

FDA Approval Process Update for Lamotrigine by Alembic Pharmaceuticals

FDA Accepts Supplement Application for Celecoxib by Alembic

Alembic's Methotrexate Sodium ANDA217552 Receives AP Status from FDA

Alembic Pharmaceuticals submits ANDA220499 for FDA review

Alembic's Methotrexate Sodium ANDA220225 Receives AP Status from FDA

Alembic's ANDA215230 for Brimonidine Tartrate and Timolol Maleate Receives AP Status

Clinical activity

Competitive activity(1)

FDA Approves Lamotrigine Supplement from Alembic Pharmaceuticals

Assets

Therapeutic areas

Indications

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