Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
01 1Macsen Labs
02 1Minakem (formerly Delmar Chemicals)
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Abbey Color
05 1Apicore
06 1EASTMAN KODAK
07 2Icrom
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 : 38960
Submission : 2023-09-27
Status :
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18791
Submission : 2005-09-16
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 : 2025-05-27
Pay. Date : 2025-05-07
DMF Number : 39334
Submission : 2023-12-30
Status :
Type : II
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A Resorcinolphthalein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Resorcinolphthalein, including repackagers and relabelers. The FDA regulates Resorcinolphthalein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Resorcinolphthalein 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 Resorcinolphthalein supplier is an individual or a company that provides Resorcinolphthalein active pharmaceutical ingredient (API) or Resorcinolphthalein finished formulations upon request. The Resorcinolphthalein suppliers may include Resorcinolphthalein API manufacturers, exporters, distributors and traders.
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A Resorcinolphthalein DMF (Drug Master File) is a document detailing the whole manufacturing process of Resorcinolphthalein active pharmaceutical ingredient (API) in detail. Different forms of Resorcinolphthalein DMFs exist exist since differing nations have different regulations, such as Resorcinolphthalein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Resorcinolphthalein DMF submitted to regulatory agencies in the US is known as a USDMF. Resorcinolphthalein USDMF includes data on Resorcinolphthalein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Resorcinolphthalein USDMF is kept confidential to protect the manufacturer’s intellectual property.
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