Holds one active US DMF and 2 valid CEPs for mexiletine, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.
Holds 2 active US DMFs for mexiletine, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Holds one active US DMF for mexiletine, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Holds one active US DMF for mexiletine, filing since 2020. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Holds 2 active US DMFs for mexiletine, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds one active US DMF for mexiletine, filing since 2020. Its 2025 FDA inspection closed as NAI.
The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.
Open the full list with a free accountThis page filters the worldwide Mexiletine manufacturer list to companies based in India. 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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