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List of Drug Master Files (JDMF) for L-Malic Acid Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Nippon Rikagaku Yakuhin Co., Ltd. (1)

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01 Outsiders regulations malic acid cysteine (1)

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01 Japan (1)

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217MF10062
4-2-2 Nihonbashi Honmachi, Chuo-ku,...
2007-01-10
2005-05-20
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Looking for 97-67-6 / L-Malic Acid API manufacturers, exporters & distributors?

L-Malic Acid manufacturers, exporters & distributors 1

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PharmaCompass offers a list of L-Malic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right L-Malic Acid manufacturer or L-Malic Acid supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Malic Acid manufacturer or L-Malic Acid supplier.

PharmaCompass also assists you with knowing the L-Malic Acid API Price utilized in the formulation of products. L-Malic Acid API Price is not always fixed or binding as the L-Malic Acid Price is obtained through a variety of data sources. The L-Malic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

L-Malic Acid

Synonyms

97-67-6, L-(-)-malic acid, (s)-2-hydroxysuccinic acid, (s)-malic acid, L(-)-malic acid, Apple acid

Cas Number

97-67-6

Unique Ingredient Identifier (UNII)

J3TZF807X5

About L-Malic Acid

L-Malic acid is a metabolite found in or produced by Escherichia coli (strain K12, MG1655).

L-Malic Acid Manufacturers

A L-Malic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Malic Acid, including repackagers and relabelers. The FDA regulates L-Malic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Malic Acid 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-Malic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

L-Malic Acid Suppliers

A L-Malic Acid supplier is an individual or a company that provides L-Malic Acid active pharmaceutical ingredient (API) or L-Malic Acid finished formulations upon request. The L-Malic Acid suppliers may include L-Malic Acid API manufacturers, exporters, distributors and traders.

click here to find a list of L-Malic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

L-Malic Acid JDMF

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-Malic Acid Drug Master File in Japan (L-Malic Acid JDMF) empowers L-Malic Acid 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-Malic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of L-Malic Acid 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-Malic Acid suppliers with JDMF on PharmaCompass.

L-Malic Acid Manufacturers | Traders | Suppliers

L-Malic Acid Manufacturers, Traders, Suppliers 1
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We have 1 companies offering L-Malic Acid

Get in contact with the supplier of your choice:

  1. Nihon Rikagaku
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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