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 2Dishman Carbogen Amcis
01 1INDIGOTIN DISULFONATE SODIUM
02 1INDIGOTINDISULFONATE SODIUM
03 2INDIGOTINDISULFONATE SODIUM USP
01 4India
01 3Active
02 1Inactive
01 1Complete
02 3Blank
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 : 40119
Submission : 2024-06-25
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-15
Pay. Date : 2017-01-12
DMF Number : 31299
Submission : 2017-01-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32910
Submission : 2018-06-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32702
Submission : 2018-05-14
Status : Inactive
Type : II
A Indigo Carmine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indigo Carmine, including repackagers and relabelers. The FDA regulates Indigo Carmine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indigo Carmine 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 Indigo Carmine supplier is an individual or a company that provides Indigo Carmine active pharmaceutical ingredient (API) or Indigo Carmine finished formulations upon request. The Indigo Carmine suppliers may include Indigo Carmine API manufacturers, exporters, distributors and traders.
click here to find a list of Indigo Carmine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indigo Carmine DMF (Drug Master File) is a document detailing the whole manufacturing process of Indigo Carmine active pharmaceutical ingredient (API) in detail. Different forms of Indigo Carmine DMFs exist exist since differing nations have different regulations, such as Indigo Carmine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indigo Carmine DMF submitted to regulatory agencies in the US is known as a USDMF. Indigo Carmine USDMF includes data on Indigo Carmine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indigo Carmine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indigo Carmine suppliers with USDMF on PharmaCompass.
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