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01 1Shilpa Pharma Lifesciences Limited
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01 1Busulfan
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01 1India
Registration Number : 230MF10027
Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India
Initial Date of Registration : 2018-02-15
Latest Date of Registration : 2018-02-15
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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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Busulfan Drug Master File in Japan (Busulfan JDMF) empowers Busulfan API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Busulfan JDMF during the approval evaluation for pharmaceutical products. At the time of Busulfan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Busulfan suppliers with JDMF on PharmaCompass.
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