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01 1M/s Glenmark Life Sciences Limited
02 1M/s Maps Laboratories Pvt ltd
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01 1Gabapentin Enacarbil (IH)
02 1Gabapentin Enacarbil IH
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01 1WC-0310
02 1WC-0331
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01 2India
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm : Plot No. Z-103/l, Dahej SEZ, Phase ll, Dahej, Dist-Bharuch, Gujarat
Date of Issue : 2022-04-04
Valid Till : 2025-01-13
Written Confirmation Number : WC-0331
Address of the Firm : Plot No. 38, Rafaleshwar, GIDC, N. H. No 8/A, At & post Jambudia - 363 642 Tal: ...
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A (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid written confirmation ((1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid WC) is an official document issued by a regulatory agency to a (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid manufacturer, verifying that the manufacturing facility of a (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid APIs or (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid finished pharmaceutical products to another nation, regulatory agencies frequently require a (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid WC (written confirmation) as part of the regulatory process.
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