Holds one active US DMF for varenicline, filing since 2010. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.
Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.
Holds one active US DMF for varenicline, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.
Holds one active US DMF for varenicline, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.
Holds one active US DMF for varenicline, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Holds 2 active US DMFs for varenicline, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.
Holds one active US DMF for varenicline, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds 2 active US DMFs for varenicline, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.
Holds one active US DMF for varenicline, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Holds one active US DMF for varenicline, filing since 2010. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Holds one active US DMF for varenicline, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.
Holds one active US DMF for varenicline, filing since 2018. Its 2024 FDA inspection closed as NAI.
Holds 2 active US DMFs for varenicline, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Holds one active US DMF for varenicline, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Holds 2 active US DMFs for varenicline, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Holds one active US DMF for varenicline, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds 2 active US DMFs for varenicline, filing since 2018. Its 2022 FDA inspection closed as VAI.
Holds one active US DMF for varenicline, filing since 2010. Its 2025 FDA inspection closed as VAI.
Registered with SFDA (Saudi Arabia) for varenicline.
The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.
Contract manufacturers make to order rather than holding their own filing for this molecule.
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. Every factor appears on the card it produced. Read the full method.
Ask Fred which manufacturers are on record for varenicline and what filings they hold.
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