Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1BCN Peptides S. A.
03 1ILS Inc.
04 1Peptisyntha, Inc.
01 2Buserelin
02 1Buserelin acetate "Ito"
03 1Buserelin acetate "Mitsuba"
01 1Germany
02 1Spain
03 1Switzerland
04 1U.S.A
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 225MF10159
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2013-08-14
Latest Date of Registration : 2013-08-14
Registration Number : 305MF10126
Registrant's Address : Poligono industrial Els Vinyets-Els Fogars. Sector II 08777-Sant Quinti de Mediona, B...
Initial Date of Registration : 2023-11-29
Latest Date of Registration : 2023-11-29
Registration Number : 219MF10206
Registrant's Address : 20910 Higgins Court Torrance, California USA 90501-1722
Initial Date of Registration : 2007-06-13
Latest Date of Registration : 2007-06-13
Registration Number : 219MF10292
Registrant's Address : Randic Kanda Building, 2-6 Kanda Sudacho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2007-09-10
Latest Date of Registration : 2007-09-10
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A (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone, including repackagers and relabelers. The FDA regulates (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone supplier is an individual or a company that provides (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone active pharmaceutical ingredient (API) or (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone finished formulations upon request. The (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone suppliers may include (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone API manufacturers, exporters, distributors and traders.
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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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone Drug Master File in Japan ((D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone JDMF) empowers (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone JDMF during the approval evaluation for pharmaceutical products. At the time of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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We have 4 companies offering (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone
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