Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 2Macsen Labs
04 1ChemCon GmbH
05 1ISO TEX DIAGNOSTICS INC
06 1Icrom
07 1Luitpold Pharmaceuticals, Inc.
08 1Mikrochem
09 1Provepharm Life Solutions
10 1Sichuan Qingmu Pharmaceutical
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-26
Pay. Date : 2023-09-26
DMF Number : 32900
Submission : 2023-09-21
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-28
Pay. Date : 2022-05-10
DMF Number : 36603
Submission : 2022-06-01
Status :
Type : II
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-18
Pay. Date : 2023-08-28
DMF Number : 35095
Submission : 2020-08-17
Status :
Type : II
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 : 35482
Submission : 2020-12-22
Status :
Type : IV
A Methylene Blue manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylene Blue, including repackagers and relabelers. The FDA regulates Methylene Blue manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylene Blue 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 Methylene Blue manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylene Blue supplier is an individual or a company that provides Methylene Blue active pharmaceutical ingredient (API) or Methylene Blue finished formulations upon request. The Methylene Blue suppliers may include Methylene Blue API manufacturers, exporters, distributors and traders.
click here to find a list of Methylene Blue suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylene Blue DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylene Blue active pharmaceutical ingredient (API) in detail. Different forms of Methylene Blue DMFs exist exist since differing nations have different regulations, such as Methylene Blue USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylene Blue DMF submitted to regulatory agencies in the US is known as a USDMF. Methylene Blue USDMF includes data on Methylene Blue's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylene Blue USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methylene Blue suppliers with USDMF on PharmaCompass.
We have 10 companies offering Methylene Blue
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