Axplora- The partner of choice for complex APIs.
01 1Axplora
02 2Ajinomoto Company
03 1Chifeng Arker Pharmaceutical Technology Co. Ltd.
04 1Corden Pharma Bergamo S.p.A
05 1Formosa Laboratories
06 1Ipca Laboratories
07 1Olon S.p.A
08 1Signa S.A. de C.V.
09 1Blank
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-10
Pay. Date : 2021-08-06
DMF Number : 16425
Submission : 2003-02-17
Status :
Type : II
A Balsalazide Disodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Balsalazide Disodium, including repackagers and relabelers. The FDA regulates Balsalazide Disodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Balsalazide Disodium 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 Balsalazide Disodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Balsalazide Disodium supplier is an individual or a company that provides Balsalazide Disodium active pharmaceutical ingredient (API) or Balsalazide Disodium finished formulations upon request. The Balsalazide Disodium suppliers may include Balsalazide Disodium API manufacturers, exporters, distributors and traders.
click here to find a list of Balsalazide Disodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Balsalazide Disodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Balsalazide Disodium active pharmaceutical ingredient (API) in detail. Different forms of Balsalazide Disodium DMFs exist exist since differing nations have different regulations, such as Balsalazide Disodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Balsalazide Disodium DMF submitted to regulatory agencies in the US is known as a USDMF. Balsalazide Disodium USDMF includes data on Balsalazide Disodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Balsalazide Disodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Balsalazide Disodium suppliers with USDMF on PharmaCompass.
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