01 1SIGMA-ALDRICH ISRAEL Ltd.
01 1Dactinomycin USP
01 1U.S.A
Registration Number : 221MF10187
Registrant's Address : 13 Kiryat Mada Street, Har Hotzvim Industrial Park Jerusalem, 97770 ISRAEL
Initial Date of Registration : 2009-08-13
Latest Date of Registration : 2017-02-13
A Dactinomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dactinomycin, including repackagers and relabelers. The FDA regulates Dactinomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dactinomycin 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 Dactinomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dactinomycin supplier is an individual or a company that provides Dactinomycin active pharmaceutical ingredient (API) or Dactinomycin finished formulations upon request. The Dactinomycin suppliers may include Dactinomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Dactinomycin 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 Dactinomycin Drug Master File in Japan (Dactinomycin JDMF) empowers Dactinomycin 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 Dactinomycin JDMF during the approval evaluation for pharmaceutical products. At the time of Dactinomycin 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 Dactinomycin suppliers with JDMF on PharmaCompass.
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