Sm Biomed Sdn. Bhd.
Overview
Pharmaceutical manufacturing site surfaced via EU GMP non-compliance screening (EudraGMDP).
API / Drug Master Files
Sm Biomed Sdn. Bhd. 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.
- ERYTHROMYCIN BASE DIHYDRATE USPActive2017-12-05
- ERYTHROMYCIN STEARATE USPActive2017-11-16
- ERYTHROMYCIN ETHYLSUCCINATE USPActive2017-09-08
- ERYTHROMYCIN BASE USPActive2011-05-17
FDA compliance signals
1 FDA enforcement record linked to this company.
- eu_noncompliance2025-12-11
EU GMP Statement of Non-Compliance
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