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 1EASTMAN KODAK
06 2Icrom
01 2FLUORESCEIN
02 3FLUORESCEIN SODIUM
03 1FLUORESCEIN SODIUM USP
04 1FLUORESCEIN USP
01 1Canada
02 2India
03 2Italy
04 2U.S.A
01 6Active
02 1Inactive
01 2Complete
02 5Blank
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 : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18791
Submission : 2005-09-16
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 : 39334
Submission : 2023-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-03
Pay. Date : 2014-05-01
DMF Number : 19777
Submission : 2006-09-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9094
Submission : 1991-05-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-21
Pay. Date : 2024-02-07
DMF Number : 39362
Submission : 2024-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29144
Submission : 2015-03-05
Status : Active
Type : II
A Fluorescein, Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorescein, Sodium, including repackagers and relabelers. The FDA regulates Fluorescein, Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorescein, 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 Fluorescein, Sodium supplier is an individual or a company that provides Fluorescein, Sodium active pharmaceutical ingredient (API) or Fluorescein, Sodium finished formulations upon request. The Fluorescein, Sodium suppliers may include Fluorescein, Sodium API manufacturers, exporters, distributors and traders.
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A Fluorescein, Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluorescein, Sodium active pharmaceutical ingredient (API) in detail. Different forms of Fluorescein, Sodium DMFs exist exist since differing nations have different regulations, such as Fluorescein, Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluorescein, Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Fluorescein, Sodium USDMF includes data on Fluorescein, Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluorescein, Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluorescein, Sodium suppliers with USDMF on PharmaCompass.
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