Synbias Pharma: Global Leadership in High-Potency APIs for Oncology and Specialized Therapies
01 1Gemini PharmChem Mannheim GmbH
02 2Meiji Seika Pharma Co., Ltd.
03 1Nippon Microbiopharmacist Co., Ltd.
04 1Olon S. p. A.
05 1Zhejiang Hisun Pharmaceutical Co. , Ltd.
01 1Day stations doxorubicin hydrochloride
02 3Doxorubicin Hydrochloride
03 2Doxorubicin hydrochloride
01 1China
02 1Italy
03 3Japan
04 1Switzerland
Synbias Pharma: Global Leadership in High-Potency APIs for Oncology and Specialized Therapies
Registration Number : 305MF10028
Registrant's Address : Sandhofer Strasse 96, 68305 Mannheim, Germany
Initial Date of Registration : 2023-02-15
Latest Date of Registration : 2023-02-15
Registration Number : 218MF10960
Registrant's Address : 2-4-16 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2006-12-01
Registration Number : 302MF10073
Registrant's Address : 2-4-16 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2020-07-01
Latest Date of Registration : 2020-07-01
Japanese Pharmacopoeia Doxorubicin Hydrochloride
Registration Number : 223MF10126
Registrant's Address : 1-3-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-08-09
Latest Date of Registration : 2024-02-21
Registration Number : 303MF10121
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2021-08-02
Latest Date of Registration : 2021-08-02
Registration Number : 226MF10124
Registrant's Address : 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province, P. R. China 3180...
Initial Date of Registration : 2014-07-01
Latest Date of Registration : 2014-07-01
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A NCGC00024415-36 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00024415-36, including repackagers and relabelers. The FDA regulates NCGC00024415-36 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00024415-36 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 NCGC00024415-36 supplier is an individual or a company that provides NCGC00024415-36 active pharmaceutical ingredient (API) or NCGC00024415-36 finished formulations upon request. The NCGC00024415-36 suppliers may include NCGC00024415-36 API manufacturers, exporters, distributors and traders.
click here to find a list of NCGC00024415-36 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 NCGC00024415-36 Drug Master File in Japan (NCGC00024415-36 JDMF) empowers NCGC00024415-36 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 NCGC00024415-36 JDMF during the approval evaluation for pharmaceutical products. At the time of NCGC00024415-36 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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