Elapegademase-lvlr

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

1 API Suppliers, 1 JDMF

DOSSIERs // Finished Dosage Formulations

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Exelead, Inc.

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elapeguademase

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JDMF Registration Number

230MF10020

Registrant's Address

6925 Guion Road, Indianapolis, IN 4...

Latest Date of Registration

2023-11-08

Initial Date of Registration

2018-02-05

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Looking for 1709806-75-6 / Elapegademase API manufacturers, exporters & distributors?

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

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

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

API | Excipient name

Elapegademase

Synonyms

Revcovi, Elapegademase-lvlr, Elapegademase [inn], Unii-9r3d3y0uhs, Elapegademase [usan:inn], 9r3d3y0uhs

Cas Number

1709806-75-6

About Elapegademase

Elapegademase is a recombinant form of the enzyme adenosine deaminase (rADA), based on the bovine amino acid sequence and covalently conjugated, with a succinimidyl carbamate linker, to monomethoxypolyethylene glycol (mPEG) (SC-PEG rADA), that can be used as an enzyme replacement agent for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID). Upon intramuscular administration, elapegademase, as an exogenous source of ADA, replaces the deficient ADA enzyme and acts in the same manner as the endogenous enzyme. ADA is involved in purine metabolism and mainly catalyzes the irreversible hydrolytic deamination of adenosine or deoxyadenosine to inosine or deoxyinosine, respectively, as well as several naturally occurring methylated adenosine compounds. Elapegademase decreases toxic levels of adenosine and deoxyadenosine nucleotides, increases lymphocyte levels and helps maintain the proper functioning of immune cells. Elevated adenosine levels, as seen in ADA deficiency, induce apoptosis and inhibit the differentiation of thymocytes, resulting in T-lymphopenia. Low levels of deoxyadenosine and adenosine play key roles in the regulation of lymphocyte levels and the proper functioning of immune cells.

Elapegademase-lvlr Manufacturers

A Elapegademase-lvlr manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elapegademase-lvlr, including repackagers and relabelers. The FDA regulates Elapegademase-lvlr manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elapegademase-lvlr API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Elapegademase-lvlr Suppliers

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

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

Elapegademase-lvlr 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 Elapegademase-lvlr Drug Master File in Japan (Elapegademase-lvlr JDMF) empowers Elapegademase-lvlr 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 Elapegademase-lvlr JDMF during the approval evaluation for pharmaceutical products. At the time of Elapegademase-lvlr JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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Elapegademase-lvlr Manufacturers | Traders | Suppliers

We have 1 companies offering Elapegademase-lvlr

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Exelead

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.