Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
01 1Goserelin Acetate
01 1Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 304MF10160
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2022-12-23
Latest Date of Registration : 2022-12-23
A Goserelin acetate (JAN/USP) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Goserelin acetate (JAN/USP), including repackagers and relabelers. The FDA regulates Goserelin acetate (JAN/USP) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Goserelin acetate (JAN/USP) 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 Goserelin acetate (JAN/USP) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Goserelin acetate (JAN/USP) supplier is an individual or a company that provides Goserelin acetate (JAN/USP) active pharmaceutical ingredient (API) or Goserelin acetate (JAN/USP) finished formulations upon request. The Goserelin acetate (JAN/USP) suppliers may include Goserelin acetate (JAN/USP) API manufacturers, exporters, distributors and traders.
click here to find a list of Goserelin acetate (JAN/USP) 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 Goserelin acetate (JAN/USP) Drug Master File in Japan (Goserelin acetate (JAN/USP) JDMF) empowers Goserelin acetate (JAN/USP) 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 Goserelin acetate (JAN/USP) JDMF during the approval evaluation for pharmaceutical products. At the time of Goserelin acetate (JAN/USP) 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 Goserelin acetate (JAN/USP) suppliers with JDMF on PharmaCompass.
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