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01 1Evonik Rexim (Nanning) Pharmaceutical Co. , Ltd.
02 1Kamiishiwa Anko Acid Co., Ltd.
03 1SHINE STAR (HUBEI) BIOLOGICAL ENGINEERING CO. , LTD.
01 1Japanese Pharmacopoeia L- valine (production only)
02 1L- valine L-Valine
03 1L-VALINE
01 1China
02 1Germany
03 1Blank
Registration Number : 228MF10022
Registrant's Address : No. 46 Wenjiang Road, Wuming District, Nanning, 530199, Guangxi, P. R. China
Initial Date of Registration : 2016-02-02
Latest Date of Registration : 2019-06-18
Registration Number : 305MF10089
Registrant's Address : No. 666 Chanling Avenue, Douhudi Town, Gong An, Jingzhou, Hubei, P. R. China
Initial Date of Registration : 2023-07-26
Latest Date of Registration : 2023-07-26
Japanese Pharmacopoeia L-Valine (for manufacturing only)
Registration Number : 229MF10081
Registrant's Address : No. 158, Xinduan Road, Gongyuan District, Qingpu, Shanghai City, China
Initial Date of Registration : 2017-04-11
Latest Date of Registration : 2017-04-11
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A L-VALINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-VALINE, including repackagers and relabelers. The FDA regulates L-VALINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-VALINE 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 L-VALINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-VALINE supplier is an individual or a company that provides L-VALINE active pharmaceutical ingredient (API) or L-VALINE finished formulations upon request. The L-VALINE suppliers may include L-VALINE API manufacturers, exporters, distributors and traders.
click here to find a list of L-VALINE 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 L-VALINE Drug Master File in Japan (L-VALINE JDMF) empowers L-VALINE 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 L-VALINE JDMF during the approval evaluation for pharmaceutical products. At the time of L-VALINE 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 L-VALINE suppliers with JDMF on PharmaCompass.
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