Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Apicore LLC
03 1Archimica
04 1ChemPacific Corp
05 1DMFs Not Supported
06 2Emcure Pharmaceuticals
07 1Fareva
08 1Fresenius Kabi AB Brunna
09 1Shilpa Medicare
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-08
Pay. Date : 2012-12-17
DMF Number : 25933
Submission : 2012-03-27
Status :
Type : II
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PharmaCompass offers a list of Busulfan 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 Busulfan manufacturer or Busulfan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Busulfan manufacturer or Busulfan supplier.
PharmaCompass also assists you with knowing the Busulfan API Price utilized in the formulation of products. Busulfan API Price is not always fixed or binding as the Busulfan Price is obtained through a variety of data sources. The Busulfan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Busulfan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Busulfan, including repackagers and relabelers. The FDA regulates Busulfan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Busulfan 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 Busulfan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Busulfan supplier is an individual or a company that provides Busulfan active pharmaceutical ingredient (API) or Busulfan finished formulations upon request. The Busulfan suppliers may include Busulfan API manufacturers, exporters, distributors and traders.
click here to find a list of Busulfan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Busulfan DMF (Drug Master File) is a document detailing the whole manufacturing process of Busulfan active pharmaceutical ingredient (API) in detail. Different forms of Busulfan DMFs exist exist since differing nations have different regulations, such as Busulfan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Busulfan DMF submitted to regulatory agencies in the US is known as a USDMF. Busulfan USDMF includes data on Busulfan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Busulfan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Busulfan suppliers with USDMF on PharmaCompass.
We have 8 companies offering Busulfan
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