01 2CHENGDA PHARMACEUTICALS CO. , LTD.
02 2Kongo Chemical Co., Ltd.
03 1Liaoning Koncepnutra Co. , Ltd.
04 1Northeast Pharmaceutical Group Co. , Ltd.
01 1Carnitine chloride (production only)
02 1Levocarnine
03 2Levocarnitine
04 1Levocarnitine chloride
05 1Levocarnitine chloride "Congo"
01 4China
02 2Japan
Registration Number : 301MF10030
Registrant's Address : No. 36, Huanghe Road, Huimin Subdistrict, Jiashan, Jiaxing, Zhejiang, 314100, China
Initial Date of Registration : 2019-07-10
Latest Date of Registration : 2019-07-10
Registration Number : 225MF10026
Registrant's Address : No. 5, Hengshan Road, United Development Zone, Jianshan, Zhejiang, China
Initial Date of Registration : 2013-02-13
Latest Date of Registration : 2013-02-13
Carnitine chloride (for manufacturing only)
Registration Number : 217MF11192
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-03-09
Levocarnitine chloride "Congo"
Registration Number : 221MF10004
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2009-01-13
Latest Date of Registration : 2009-01-13
Registration Number : 303MF10023
Registrant's Address : No. 100 Xianghuai Road, Benxi Economic Development Zone, Liaoning, China
Initial Date of Registration : 2021-02-01
Latest Date of Registration : 2021-11-17
Registration Number : 303MF10012
Registrant's Address : No. 8, Kunminghu Street, Economic & Technology Development District, Shenyang, China
Initial Date of Registration : 2021-01-26
Latest Date of Registration : 2021-01-26
A Levocarnitine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levocarnitine, including repackagers and relabelers. The FDA regulates Levocarnitine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levocarnitine 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 Levocarnitine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levocarnitine supplier is an individual or a company that provides Levocarnitine active pharmaceutical ingredient (API) or Levocarnitine finished formulations upon request. The Levocarnitine suppliers may include Levocarnitine API manufacturers, exporters, distributors and traders.
click here to find a list of Levocarnitine 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 Levocarnitine Drug Master File in Japan (Levocarnitine JDMF) empowers Levocarnitine 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 Levocarnitine JDMF during the approval evaluation for pharmaceutical products. At the time of Levocarnitine 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 Levocarnitine suppliers with JDMF on PharmaCompass.
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