Alembic Pharmaceuticals Limited
Overview
Alembic Pharmaceuticals Limited is an Indian multinational pharmaceutical company primarily dealing in the manufacturing and marketing of pharmaceutical products and active pharmaceutical ingredients (APIs). The company is committed to research and development activities to innovate new medications and improve existing therapies.
Therapeutic areas
API / Drug Master Files
Alembic Pharmaceuticals Limited holds 148 active (162 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ADAPALENE USPActive2026-03-31
- LINAGLIPTINActive2026-03-30
- ARIPIPRAZOLE MONOHYDRATEActive2026-03-27
- FLUPHENAZINE DECANOATE USPActive2026-03-25
- TIRZEPATIDEActive2026-02-25
- CILOSTAZOL USPActive2026-02-03
- DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE USPActive2025-12-29
- ENZALUTAMIDEActive2025-12-25
- RUXOLITINIB PHOSPHATEActive2025-07-31
- RIBOCICLIB SUCCINATEActive2025-03-31
- CABOZANTINIB-S-MALATEActive2025-03-27
- AMANTADINE HYDROCHLORIDE USPActive2025-03-27
- SUVOREXANTActive2025-03-19
- LEUPROLIDE ACETATE USPActive2025-02-24
- RIFAXIMINActive2024-12-31
Showing 15 of 162 Drug Master Files.
FDA compliance signals
23 FDA enforcement records linked to this company.
- recall — Class III2026-01-14
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- recall — Class III2025-11-26
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- recall — Class II2025-08-13
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- recall — Class II2025-06-18
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
- recall — Class II2025-06-04
Failed Impurities/Degradation Specifications
- 4832024-11-22
Cleaning SOP/inspection
- 4832024-11-22
Test methods
- 4832024-11-22
Control procedures to monitor and validate performance
- 4832024-11-22
Acceptance criteria for sampling & testing
- 4832024-11-22
input/output verification
- 4832024-03-08
Written record of investigation incomplete
- 4832024-03-08
Storage under appropriate conditions
- 4832024-03-08
Review of representative number of batches
- 4832024-03-08
Scientifically sound laboratory controls
- recall — Class III2023-08-23
Failed Impurities/Degradation Specifications
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