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 1EASTMAN KODAK
04 1Icrom
05 1Nantong Jinghua Pharmaceutical
06 1ORGANICA Feinchemie GmbH Wolfen
01 4INDOCYANINE GREEN
02 1INDOCYANINE GREEN DRUG SUBSTANCE
03 1INDOCYANINE GREEN USP
01 1China
02 1Germany
03 2India
04 1Italy
05 1U.S.A
01 5Active
02 1Inactive
01 2Complete
02 4Blank
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 : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36647
Submission : 2021-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 294
Submission : 1958-04-09
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-22
Pay. Date : 2023-11-09
DMF Number : 38104
Submission : 2023-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40605
Submission : 2024-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-05
Pay. Date : 2021-11-30
DMF Number : 19601
Submission : 2006-07-13
Status : Active
Type : II
A Indocyanine Green manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indocyanine Green, including repackagers and relabelers. The FDA regulates Indocyanine Green manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indocyanine 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.
click here to find a list of Indocyanine Green manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indocyanine Green supplier is an individual or a company that provides Indocyanine Green active pharmaceutical ingredient (API) or Indocyanine Green finished formulations upon request. The Indocyanine Green suppliers may include Indocyanine Green API manufacturers, exporters, distributors and traders.
click here to find a list of Indocyanine Green suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indocyanine Green DMF (Drug Master File) is a document detailing the whole manufacturing process of Indocyanine Green active pharmaceutical ingredient (API) in detail. Different forms of Indocyanine Green DMFs exist exist since differing nations have different regulations, such as Indocyanine Green USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indocyanine Green DMF submitted to regulatory agencies in the US is known as a USDMF. Indocyanine Green USDMF includes data on Indocyanine Green's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indocyanine Green USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indocyanine Green suppliers with USDMF on PharmaCompass.
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