Berotralstat Hydrochloride API Manufacturers | Suppliers | Drug Master Files (DMF) | CEP

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01

Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

World Vaccine Conference

Not Confirmed

02

Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

World Vaccine Conference

Not Confirmed

03

Apicore

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

World Vaccine Conference

Not Confirmed

04

Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

World Vaccine Conference

Not Confirmed

Looking for 1809010-50-1 / Berotralstat API manufacturers, exporters & distributors?

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

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

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

API | Excipient name

Berotralstat

Synonyms

1809010-50-1, Bcx7353, Berotralstat [inn], Berotralstat [usan], Xza0kb1bdq, Bcx-7353

Cas Number

1809010-50-1

Unique Ingredient Identifier (UNII)

XZA0KB1BDQ

About Berotralstat

Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Developed by BioCryst Pharmaceuticals, berotralstat is taken once-daily as oral capsules. Under the market name Orladeyo, berotralstat was approved by the FDA on December 3, 2020, as the first oral, once-daily therapy to prevent angioedema attacks of HAE in adults and pediatric patients 12 years and older. In clinical trials, berotralstat was shown to significantly reduce attack rates at 24 weeks compared to placebo, which was sustained through 48 weeks. Berotralstat is strictly used to prevent, but not treat, these attacks. Previous oral therapies used for prophylaxis of HAE attacks, such as androgens, were limited by undesirable adverse effects and several contraindications. In clinical trials, berotralstat displayed a fast onset of action, long duration of action, and acceptable tolerance in patients.

Berotralstat Hydrochloride Manufacturers

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

Berotralstat Hydrochloride Suppliers

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

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

Berotralstat Hydrochloride Manufacturers | Traders | Suppliers

We have 3 companies offering Berotralstat Hydrochloride

Get in contact with the supplier of your choice:

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.