Accord Healthcare Ltd
Overview
Accord Healthcare Ltd is a subsidiary of Intas Pharmaceuticals, operating in the pharmaceutical industry. It focuses on developing and marketing affordable generic medications across various therapeutic areas.
Therapeutic areas
API / Drug Master Files
Accord Healthcare Ltd holds 10 active (15 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.
- ROPIVACAINE HYDROCHLORIDE USPActive2025-12-15
- BUPIVACAINE HYDROCHLORIDE USPActive2025-08-21
- ACYCLOVIR USPActive2025-07-23
- PRILOCAINE USPActive2025-06-04
- MELOXICAM USPActive2024-05-06
- LIDOCAINE HYDROCHLORIDE USPActive2023-12-01
- PIROXICAM USPActive2022-02-25
- BENZOCAINE USPActive2022-02-03
- BISACODYL USPActive2022-01-27
- LIDOCAINE USPActive2019-09-21
- LIDOCAINE HYDROCHLORIDE USPInactive2020-12-15
- BENZOCAINE USPInactive2019-10-16
- DOCETAXEL TRIHYDRATE APIInactive2008-10-23
- ANHYDROUS DOCETAXELInactive2007-06-11
- PACLITAXEL APIInactive2004-09-02
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2025-10-15
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
- recall — Class II2025-07-23
Subpotent Drug: Assay below the approved specification
- recall — Class II2025-07-23
Subpotent Drug: Assay below the approved specification
- recall — Class II2025-07-23
Subpotent Drug: Assay below the approved specification
- recall — Class II2025-07-23
Subpotent Drug: Assay below the approved specification
- recall — Class II2025-07-23
Subpotent Drug: Assay below the approved specification
- recall — Class II2025-07-23
Subpotent Drug: Assay below the approved specification
- recall — Class II2025-07-23
Subpotent Drug: Assay below the approved specification
- recall — Class II2025-05-07
Subpotent
- recall — Class II2025-05-07
Subpotent
- recall — Class II2025-05-07
Subpotent
- recall — Class II2025-05-07
Subpotent
- recall — Class II2024-12-11
Subpotent drug
- recall — Class II2024-11-06
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- recall — Class II2024-11-06
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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