01 1CARBOGEN AMCIS AG
02 1Chongqing Huapont Shengchem Pharm. Co. , Ltd.
03 1EMCURE PHARMACEUTICALS LIMITED.
04 1Fujian South Pharmaceutical Co. , Ltd.
05 1Heraeus Precious Metals GmbH & Co. K.G.
06 1Hetero Labs Limited
07 1Olon S. p. A.
01 2Bendamustine Hydrochloride
02 1Bendamustine Hydrochloride "D"
03 1Bendamustine Hydrochloride Monohydrate
04 1Bendamustine Hydrochloride monohydrate
05 1Bendamustine hydrochloride
06 1Bendamustine hydrochloride hydrate
01 2China
02 1Germany
03 2India
04 1Italy
05 1Switzerland
Registration Number : 226MF10070
Registrant's Address : Hauptstrasse 171, CH-4416 Bubendorf, Switzerland
Initial Date of Registration : 2014-03-11
Latest Date of Registration : 2019-07-10
Bendamustine hydrochloride monohydrate
Registration Number : 302MF10116
Registrant's Address : No. 69 Xingguang Avenue, Renhe Town, Yubei District, Chongqing, China
Initial Date of Registration : 2020-09-24
Latest Date of Registration : 2020-09-24
Registration Number : 302MF10138
Registrant's Address : Emcure House, T-184, M. I. D. C. ,Bhosari,Pune,Maharashtra,India
Initial Date of Registration : 2020-11-26
Latest Date of Registration : 2020-11-26
Bendamustine hydrochloride hydrate
Registration Number : 303MF10041
Registrant's Address : No. 98 Dongxin Road, Xuefeng Town, Mingxi County, Sanming City, Fujian Province 36520...
Initial Date of Registration : 2021-03-05
Latest Date of Registration : 2021-03-05
Bendamustine Hydrochloride Monohydrate
Registration Number : 302MF10088
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2020-07-29
Latest Date of Registration : 2021-11-10
Bendamustine hydrochloride "D"
Registration Number : 301MF10048
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2019-08-20
Latest Date of Registration : 2019-08-20
Registration Number : 301MF10055
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2019-08-29
Latest Date of Registration : 2023-12-06
A Bendamustine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bendamustine Hydrochloride, including repackagers and relabelers. The FDA regulates Bendamustine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bendamustine Hydrochloride 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 Bendamustine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bendamustine Hydrochloride supplier is an individual or a company that provides Bendamustine Hydrochloride active pharmaceutical ingredient (API) or Bendamustine Hydrochloride finished formulations upon request. The Bendamustine Hydrochloride suppliers may include Bendamustine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Bendamustine Hydrochloride 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 Bendamustine Hydrochloride Drug Master File in Japan (Bendamustine Hydrochloride JDMF) empowers Bendamustine Hydrochloride 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 Bendamustine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Bendamustine Hydrochloride 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 Bendamustine Hydrochloride suppliers with JDMF on PharmaCompass.
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