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List of Drug Master Files (DMF) of L-Leucine API Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 AMINO GmbH (2)

02 Ajinomoto Company (3)

03 Cambridge Isotope Laboratories Inc. (1)

04 Kyowa Hakko Bio (1)

05 Mitsubishi Tanabe Pharma (1)

06 SIGMA TAU (1)

07 SNJ Labs (1)

08 Sekisui Medical Co. Ltd (1)

09 Yoneyama Yakuhin Kogyo (1)

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01 A-KETOANALOGUE TO LEUCINE CALCIUM SALT (1)

02 L-LEUCINE (8)

03 L-LEUCINE (U-13C6) (1)

04 L-LEUCINE DRUG SUBSTANCE (1)

05 L-LEUCINE FROM FERMENTATION (1)

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01 Germany (2)

02 India (1)

03 Japan (7)

04 U.S.A (2)

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01 Active (6)

02 Inactive (6)

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01 Complete (2)

02 Blank (10)

URL Supplier Web Content
31556
Active
2017-03-21
Complete
2021-08-27
2020-11-30
II
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URL Supplier Web Content
21761
Active
2008-07-03
Complete
2017-05-12
2017-04-17
II
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URL Supplier Web Content
31258
Active
2016-12-14
N/A
II
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URL Supplier Web Content
3828
Active
1980-06-11
N/A
II
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URL Supplier Web Content
21618
Active
2008-05-15
N/A
IV
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URL Supplier Web Content
2622
Inactive
1976-02-04
N/A
II
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URL Supplier Web Content
1275
Inactive
1968-12-31
N/A
II
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URL Supplier Web Content
7223
Inactive
1987-10-19
N/A
II
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URL Supplier Web Content
2778
Inactive
1976-10-22
N/A
II
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URL Supplier Web Content
38243
Active
2023-04-03
N/A
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Looking for 61-90-5 / L-Leucine API API manufacturers, exporters & distributors?

L-Leucine API manufacturers, exporters & distributors 1

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PharmaCompass offers a list of L-Leucine API 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-Leucine API manufacturer or L-Leucine API supplier for your needs.

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

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

API | Excipient name

L-Leucine API

Synonyms

L-leucine, 61-90-5, (s)-2-amino-4-methylpentanoic acid, (s)-leucine, H-leu-oh, (2s)-2-amino-4-methylpentanoic acid

Cas Number

61-90-5

Unique Ingredient Identifier (UNII)

GMW67QNF9C

About L-Leucine API

An essential branched-chain amino acid important for hemoglobin formation.

L-Leucine API Manufacturers

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

L-Leucine API Suppliers

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

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

L-Leucine API USDMF

A L-Leucine API DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Leucine API active pharmaceutical ingredient (API) in detail. Different forms of L-Leucine API DMFs exist exist since differing nations have different regulations, such as L-Leucine API USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A L-Leucine API DMF submitted to regulatory agencies in the US is known as a USDMF. L-Leucine API USDMF includes data on L-Leucine API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Leucine API USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of L-Leucine API suppliers with USDMF on PharmaCompass.

L-Leucine API Manufacturers | Traders | Suppliers

L-Leucine API Manufacturers, Traders, Suppliers 1
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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