01 1M/s Glenmark life Sciences limited
02 1M/s Maps Laboratories Pvt Ltd
01 2Gabapentin Enacarbil IH
01 1WC-0310
02 1WC-0331A2
01 2India
Date of Issue : 2023-11-28
Valid Till : 2026-11-28
Written Confirmation Number : WC-0310
Address of the Firm : Plot No. Z-103/l, Dahej SEZ, Phase II, Dahej, Dist-Bharuch, Gujarat, India
Date of Issue : 2022-04-04
Valid Till : 2025-01-13
Written Confirmation Number : WC-0331A2
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 gabapentinum enacarbilum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gabapentinum enacarbilum, including repackagers and relabelers. The FDA regulates gabapentinum enacarbilum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gabapentinum enacarbilum API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A gabapentinum enacarbilum supplier is an individual or a company that provides gabapentinum enacarbilum active pharmaceutical ingredient (API) or gabapentinum enacarbilum finished formulations upon request. The gabapentinum enacarbilum suppliers may include gabapentinum enacarbilum API manufacturers, exporters, distributors and traders.
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A gabapentinum enacarbilum written confirmation (gabapentinum enacarbilum WC) is an official document issued by a regulatory agency to a gabapentinum enacarbilum manufacturer, verifying that the manufacturing facility of a gabapentinum enacarbilum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting gabapentinum enacarbilum APIs or gabapentinum enacarbilum finished pharmaceutical products to another nation, regulatory agencies frequently require a gabapentinum enacarbilum WC (written confirmation) as part of the regulatory process.
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