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

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01 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S. P. A. (1)

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01 Italy (1)

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227MF10276
VIA M. Civitali, 1-20148 MILANO, IT...
2016-08-16
2015-12-11
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Looking for 1188-38-1 / Carglumic Acid API manufacturers, exporters & distributors?

Carglumic Acid manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Carglumic 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 Carglumic Acid manufacturer or Carglumic Acid supplier for your needs.

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

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

API | Excipient name

Carglumic Acid

Synonyms

1188-38-1, N-carbamyl-l-glutamic acid, (s)-2-ureidopentanedioic acid, Carbaglu, N-carbamylglutamate, N-carbamoyl-l-glutamic acid

Cas Number

1188-38-1

Unique Ingredient Identifier (UNII)

5L0HB4V1EW

About Carglumic Acid

Carglumic Acid is an orally active, synthetic structural analogue of N-acetylglutamate (NAG) and carbamoyl phosphate synthetase 1 (CPS 1) activator, with ammonia lowering activity. NAG, which is formed by the hepatic enzyme N-acetylglutamate synthase (NAGS), is an essential allosteric activator of the enzyme carbamoyl phosphate synthetase 1 (CPS 1). CPS 1 plays an essential role in the urea cycle and converts ammonia into urea. Upon oral administration, carglumic acid can replace NAG in NAGS deficient patients and activates CPS 1, which prevents hyperammonaemia.

Carglumic Acid Manufacturers

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

Carglumic Acid Suppliers

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

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

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

Carglumic Acid Manufacturers | Traders | Suppliers

Carglumic Acid Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Carglumic Acid

Get in contact with the supplier of your choice:

  1. Recordati
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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