Holds one active US DMF and 2 valid CEPs for irbesartan, filing since 2019. Its 2025 FDA inspection closed as VAI.
EDQM certificate database
FDA, List of Drug Master Files
Holds one active US DMF and 2 valid CEPs for irbesartan, filing since 2019. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for irbesartan, filing since 2011. Its 2025 FDA inspection closed as NAI.
Holds 2 valid CEPs for irbesartan, filing since 2024. Its 2024 FDA inspection closed as VAI.
Holds one active US DMF and one valid CEP for irbesartan, filing since 2008. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.
The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.
This page filters the worldwide Irbesartan 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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