Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
01 1Macsen Labs
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Apicore
04 1EASTMAN KODAK
05 1Icrom
06 1Nantong Jinghua Pharmaceutical
07 1ORGANICA Feinchemie GmbH Wolfen
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40164
Submission : 2024-06-27
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-04-15
Pay. Date : 2025-03-11
DMF Number : 36647
Submission : 2021-12-30
Status :
Type : II
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PharmaCompass offers a list of Indocyanine Green API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Indocyanine Green manufacturer or Indocyanine Green supplier for your needs.
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A IC Green manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of IC Green, including repackagers and relabelers. The FDA regulates IC Green manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. IC Green 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 IC Green supplier is an individual or a company that provides IC Green active pharmaceutical ingredient (API) or IC Green finished formulations upon request. The IC Green suppliers may include IC Green API manufacturers, exporters, distributors and traders.
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A IC Green DMF (Drug Master File) is a document detailing the whole manufacturing process of IC Green active pharmaceutical ingredient (API) in detail. Different forms of IC Green DMFs exist exist since differing nations have different regulations, such as IC Green USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A IC Green DMF submitted to regulatory agencies in the US is known as a USDMF. IC Green USDMF includes data on IC Green's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The IC Green USDMF is kept confidential to protect the manufacturer’s intellectual property.
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