Overview

Pharmaceutical manufacturing site surfaced via EU GMP non-compliance screening (EudraGMDP).

API / Drug Master Files

Maithili Life Sciences Private Limited holds 4 active (4 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.

  • BILASTINEActive2026-01-30
  • CHLORZOXAZONE USPActive2025-10-11
  • EZETIMIBE USPActive2025-06-13
  • DORZOLAMIDE HYDROCHLORIDE USPActive2025-04-08

FDA compliance signals

2 FDA enforcement records linked to this company.

  • eu_noncompliance2025-10-14

    EU GMP Statement of Non-Compliance

  • eu_noncompliance2025-01-13

    EU GMP Statement of Non-Compliance

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