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List of Drug Master Files (KDMF) for Eliglustat Tartrate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Corden Pharma Switzerland LLC (1)

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01 Sanofi-Aventis Korea Co., Ltd. (1)

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01 Eliglustat Tartrate (1)

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01 Germany (1)

URL Supplier Web Content
Sanofi-Aventis Korea Co., Ltd.
2019-09-26
Number 63-7-ND
Corden Pharma Switzerland...
Switzerland
Eichenweg 1, 4410 Liestal...
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Looking for 928659-70-5 / Eliglustat API manufacturers, exporters & distributors?

Eliglustat manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Eliglustat

Synonyms

Eliglustat hemitartrate, Cerdelga, 928659-70-5, Agalsidase beta, Eliglustat (hemitartrate), Genz-112638

Cas Number

928659-70-5

Unique Ingredient Identifier (UNII)

N0493335P3

About Eliglustat

Agalsidase beta is a recombinant human -galactosidase A similar to [agalsidase alfa]. While patients generally do not experience a clinically significant difference in outcomes between the two drugs, some patients may experience greater benefit with agalsidase beta. Use of agalsidase beta has decreased in Europe, in favor of agalsidase alfa, after a contamination event in 2009. Agalsidase beta was granted FDA approval on 24 April 2003.

Eliglustat Tartrate Manufacturers

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

Eliglustat Tartrate Suppliers

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

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

Eliglustat Tartrate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Eliglustat Tartrate Drug Master File in Korea (Eliglustat Tartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eliglustat Tartrate. The MFDS reviews the Eliglustat Tartrate KDMF as part of the drug registration process and uses the information provided in the Eliglustat Tartrate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Eliglustat Tartrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Eliglustat Tartrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Eliglustat Tartrate suppliers with KDMF on PharmaCompass.

Eliglustat Tartrate Manufacturers | Traders | Suppliers

Eliglustat Tartrate Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Eliglustat Tartrate

Get in contact with the supplier of your choice:

  1. CordenPharma
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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