Holds 2 active US DMFs and 2 valid CEPs for simvastatin, filing since 2013. Its 2023 FDA inspection closed as NAI.
EDQM certificate database
FDA, List of Drug Master Files
Holds 2 active US DMFs and 2 valid CEPs for simvastatin, filing since 2013. Its 2023 FDA inspection closed as NAI.
Holds 2 active US DMFs and 2 valid CEPs for simvastatin, filing since 2018. Its 2024 FDA inspection closed as VAI.
Holds one active US DMF and 2 valid CEPs for simvastatin, filing since 2024.
Holds 3 valid CEPs for simvastatin, filing since 2025. Its 2024 FDA inspection closed as NAI.
Holds one valid CEP for simvastatin, filing since 2021. Its GMP is recognised in 1 market.
Holds 2 active US DMFs for simvastatin, filing since 2006.
Holds one active US DMF for simvastatin, filing since 2009.
This page filters the worldwide Simvastatin manufacturer list to companies based in China. The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Read the full method.
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