Holds 4 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2019. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.
EDQM certificate database
FDA, List of Drug Master Files
Holds 4 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2019. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.
Holds one active US DMF and one valid CEP for sitagliptin, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.
Holds 5 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Holds one active US DMF and 6 valid CEPs for sitagliptin, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Holds one active US DMF and one valid CEP for sitagliptin, filing since 2018. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.
Holds 2 active US DMFs and one valid CEP for sitagliptin, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.
Holds 3 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.
Holds 2 active US DMFs and one valid CEP for sitagliptin, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.
Holds 2 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2019. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Holds 2 active US DMFs and 2 valid CEPs for sitagliptin, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Holds 2 active US DMFs and one valid CEP for sitagliptin, filing since 2016. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Holds one active US DMF and one valid CEP for sitagliptin, filing since 2024. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds one active US DMF for sitagliptin, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.
Holds 2 active US DMFs for sitagliptin, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.
Holds 4 valid CEPs for sitagliptin, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.
Holds 3 active US DMFs for sitagliptin, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.
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 Sitagliptin 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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