Holds one active US DMF and one valid CEP for labetalol, filing since 2019. Its 2019 FDA inspection closed as NAI.
US DMF
1 active
CEP
1 valid
Last FDA inspection
2019 · NAI
GMP recognised in
Not established
Holds one active US DMF and one valid CEP for labetalol, filing since 2019. Its 2019 FDA inspection closed as NAI.
Holds 2 active US DMFs and one valid CEP for labetalol, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Holds one active US DMF and one valid CEP for labetalol, filing since 2022. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for labetalol, filing since 2020. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Holds one active US DMF for labetalol, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.
Holds 2 active US DMFs for labetalol, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds one active US DMF for labetalol, filing since 2010. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Registered with SFDA (Saudi Arabia) for labetalol. Its GMP is recognised in 1 market.
This page filters the worldwide Labetalol 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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