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
A Amphotericin B manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amphotericin B, including repackagers and relabelers. The FDA regulates Amphotericin B manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Amphotericin B manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amphotericin B supplier is an individual or a company that provides Amphotericin B active pharmaceutical ingredient (API) or Amphotericin B finished formulations upon request. The Amphotericin B suppliers may include Amphotericin B API manufacturers, exporters, distributors and traders.
click here to find a list of 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 Amphotericin B Drug Master File in Japan (Amphotericin B JDMF) empowers 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 Amphotericin B JDMF during the approval evaluation for pharmaceutical products. At the time of 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 Amphotericin B suppliers with JDMF on PharmaCompass.
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