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
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 :
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 :
Type : II
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PharmaCompass offers a list of Indigo Carmine 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 Indigo Carmine manufacturer or Indigo Carmine supplier for your needs.
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A Indigotindisulfonate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indigotindisulfonate Sodium, including repackagers and relabelers. The FDA regulates Indigotindisulfonate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indigotindisulfonate Sodium 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 Indigotindisulfonate Sodium supplier is an individual or a company that provides Indigotindisulfonate Sodium active pharmaceutical ingredient (API) or Indigotindisulfonate Sodium finished formulations upon request. The Indigotindisulfonate Sodium suppliers may include Indigotindisulfonate Sodium API manufacturers, exporters, distributors and traders.
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A Indigotindisulfonate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Indigotindisulfonate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Indigotindisulfonate Sodium DMFs exist exist since differing nations have different regulations, such as Indigotindisulfonate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indigotindisulfonate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Indigotindisulfonate Sodium USDMF includes data on Indigotindisulfonate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indigotindisulfonate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
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