01 1Synbiotics Limited
02 2Xellia Pharmaceuticals ApS
01 2Amphotericin B
02 1Japanese Pharmacopoeia amphotericin B
01 2Denmark
02 1India
Registration Number : 222MF10230
Registrant's Address : Plot No. 570,571,576A, Maitry Marg, ECP Canal Road, Village-LUNA, Ta. Padra, Dist. Va...
Initial Date of Registration : 2010-09-16
Latest Date of Registration : 2010-09-16
Japanese Pharmacopoeia Amphotericin B
Registration Number : 219MF10325
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2007-10-24
Latest Date of Registration : 2012-02-09
Registration Number : 303MF10154
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2021-09-28
Latest Date of Registration : 2023-10-04
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PharmaCompass offers a list of Amphotericin 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 Amphotericin manufacturer or Amphotericin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amphotericin manufacturer or Amphotericin supplier.
PharmaCompass also assists you with knowing the Amphotericin API Price utilized in the formulation of products. Amphotericin API Price is not always fixed or binding as the Amphotericin Price is obtained through a variety of data sources. The Amphotericin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Liposomal Amphotericin B manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Liposomal Amphotericin B, including repackagers and relabelers. The FDA regulates Liposomal Amphotericin B manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Liposomal Amphotericin B 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 Liposomal Amphotericin B manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Liposomal Amphotericin B supplier is an individual or a company that provides Liposomal Amphotericin B active pharmaceutical ingredient (API) or Liposomal Amphotericin B finished formulations upon request. The Liposomal Amphotericin B suppliers may include Liposomal Amphotericin B API manufacturers, exporters, distributors and traders.
click here to find a list of Liposomal Amphotericin B 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 Liposomal Amphotericin B Drug Master File in Japan (Liposomal Amphotericin B JDMF) empowers Liposomal Amphotericin B 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 Liposomal Amphotericin B JDMF during the approval evaluation for pharmaceutical products. At the time of Liposomal Amphotericin B 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 Liposomal Amphotericin B suppliers with JDMF on PharmaCompass.
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