Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
01 1M/s Macsen Drugs
01 1Indocyanin Green USP
01 1WC-0438
01 1India
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
Date of Issue : 2025-10-15
Valid Till : 2028-10-14
Written Confirmation Number : WC-0438
Address of the Firm : F-261, 262, 263, Riico Ind. Area, Gudli, Udaipur (Rajasthan), India
93
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A ICG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ICG, including repackagers and relabelers. The FDA regulates ICG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ICG 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 ICG supplier is an individual or a company that provides ICG active pharmaceutical ingredient (API) or ICG finished formulations upon request. The ICG suppliers may include ICG API manufacturers, exporters, distributors and traders.
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A ICG written confirmation (ICG WC) is an official document issued by a regulatory agency to a ICG manufacturer, verifying that the manufacturing facility of a ICG active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ICG APIs or ICG finished pharmaceutical products to another nation, regulatory agencies frequently require a ICG WC (written confirmation) as part of the regulatory process.
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