01 1Ajinomoto do Brazil Industria e Comercio de Alimentos Ltda.
02 1Daesang Co., Ltd.
03 1Global Life Sciences Solutions Singapore Pte. Ltd.
04 2HyClone Laboratories
05 2HyClone Laboratories, INC.
06 1HyClone Laboratories, Inc.
07 1Kyowa Hakko Bio Co., Ltd.
08 1SAFC Biosciences, Inc.
09 1Sigma-Aldrich Company Limited Trading As SAFC
01 2Japanese Pharmacopoeia L- glutamine (production only)
02 1L- glutamine
03 2Medium / Medium Additive ・ EX-CELL (TM) 6GRO w / L-Glutamine
04 1Medium / Medium Additives HyClone CDM4CHO with L-Glutamine
05 1Medium / Medium Additives HyClone SH3A3995-SFM4Insect with L-Glutamine Logan
06 1Medium / Medium Additives HyClone SH3A3995-SFM4Insect with L-Glutamine Singapore
07 1Medium / Medium Additives HyClone SH3A4387-SFM4Insect with L-Glutamine Logan
08 1Medium / medium additive · HyClone Cell Boost 3 Supplemen t without L-Glutamine SH30825
09 1Medium / medium additive · HyClone SFM4CHO (HYC CP101 8) Complete Powder without L-Glutamine SH305 18
01 3Japan
02 8U.S.A
Japanese Pharmacopoeia L-Glutamine (for manufacturing only)
Registration Number : 220MF10239
Registrant's Address : Avenida Oriento, s/n Bairro Entre Rios-CEP 18500-000, Laranjal Paulista, SP, Brazil
Initial Date of Registration : 2008-11-25
Latest Date of Registration : 2008-11-25
Registration Number : 217MF10597
Registrant's Address : 120 Changgyeonggung-ro, Jongno-gu, Seoul, Republic of Korea
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2014-10-27
Culture medium/culture medium additives ・HyClone CDM4CHO with L-Glutamine
Registration Number : 301MF40012
Registrant's Address : 925 West 1800 South Logan Utah 84321 USA
Initial Date of Registration : 2019-05-31
Latest Date of Registration : 2019-05-31
Culture medium/culture medium additives ・HyClone Cell Boost 3 Supplement without L-Glutamine SH30825
Registration Number : 229MF40044
Registrant's Address : 925 West 1800 South Logan Utah 84321 USA
Initial Date of Registration : 2017-12-25
Latest Date of Registration : 2017-12-25
Culture medium/culture medium additives ・HyClone SH3A4387-SFM4 Insect with L-Glutamine Logan
Registration Number : 303MF40066
Registrant's Address : 925 West 1800 South Logan Utah 84321 USA
Initial Date of Registration : 2021-09-09
Latest Date of Registration : 2021-09-09
Culture medium/culture medium additives ・HyClone SH3A3995-SFM4 Insect with L-Glutamine Logan
Registration Number : 303MF40065
Registrant's Address : 925 West 1800 South Logan Utah 84321 USA
Initial Date of Registration : 2021-09-09
Latest Date of Registration : 2021-09-09
Culture medium/culture medium additives ・HyClone SH3A3995-SFM4 Insect with L-Glutamine Singapore
Registration Number : 303MF40064
Registrant's Address : 25 Tuas South Street 1 Singapore 638034
Initial Date of Registration : 2021-09-09
Latest Date of Registration : 2021-09-09
Japanese Pharmacopoeia L-Glutamine (for manufacturing only)
Registration Number : 220MF10245
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2008-12-04
Latest Date of Registration : 2015-02-18
Culture medium/culture medium additives: EX-CELL(TM) 6GRO w/ L-Glutamine
Registration Number : 304MF40012
Registrant's Address : 13804 West 107th Street Lenexa, Kansas 66215 USA
Initial Date of Registration : 2022-03-10
Latest Date of Registration : 2022-03-10
Culture medium/culture medium additives: EX-CELL(TM) 6GRO w/ L-Glutamine
Registration Number : 304MF40011
Registrant's Address : Second Avenue Heatherhouse Industrial Estate Irvine, Scotland, United Kingdom KA12 8N...
Initial Date of Registration : 2022-03-10
Latest Date of Registration : 2022-03-10
A Glutamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glutamine, including repackagers and relabelers. The FDA regulates Glutamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glutamine 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 Glutamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glutamine supplier is an individual or a company that provides Glutamine active pharmaceutical ingredient (API) or Glutamine finished formulations upon request. The Glutamine suppliers may include Glutamine API manufacturers, exporters, distributors and traders.
click here to find a list of Glutamine 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 Glutamine Drug Master File in Japan (Glutamine JDMF) empowers Glutamine 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 Glutamine JDMF during the approval evaluation for pharmaceutical products. At the time of Glutamine 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 Glutamine suppliers with JDMF on PharmaCompass.
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