Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Aspen Oss B. V.
03 1BCN Peptides S. A.
04 1CHEMI S. p. A.
05 1PolyPeptide Laboratories (Sweden) AB
01 2Leuprorelin Acetate
02 3Leuprorelin acetate
01 1Italy
02 1Netherlands
03 1Spain
04 2Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 222MF10137
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2010-04-14
Latest Date of Registration : 2010-04-14
Aspen API. More than just an API.
Registration Number : 224MF10165
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2012-08-16
Latest Date of Registration : 2012-08-16
Registration Number : 302MF10043
Registrant's Address : Poligono industrial Els Vinyets-Els Fogars. Sector II 08777-Sant Quinti de Mediona, B...
Initial Date of Registration : 2020-04-02
Latest Date of Registration : 2020-04-02
Registration Number : 224MF10177
Registrant's Address : Via dei Laboratori 54, 20092 Cinisello Balsamo (Milano), ITALY
Initial Date of Registration : 2012-08-17
Latest Date of Registration : 2012-08-17
Registration Number : 231MF10082
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2019-04-03
Latest Date of Registration : 2024-09-03
A Leuprolide Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprolide Acetate, including repackagers and relabelers. The FDA regulates Leuprolide Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprolide Acetate 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 Leuprolide Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leuprolide Acetate supplier is an individual or a company that provides Leuprolide Acetate active pharmaceutical ingredient (API) or Leuprolide Acetate finished formulations upon request. The Leuprolide Acetate suppliers may include Leuprolide Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Leuprolide Acetate 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 Leuprolide Acetate Drug Master File in Japan (Leuprolide Acetate JDMF) empowers Leuprolide Acetate 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 Leuprolide Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Leuprolide Acetate 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 Leuprolide Acetate suppliers with JDMF on PharmaCompass.
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