Berotralstat [INN] API Manufacturers | Suppliers | Drug Master Files (DMF) | CEP

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01

Hetero Drugs

India

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

DIA 2025

Not Confirmed

02

Apicore

India

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

DIA 2025

Not Confirmed

03

Hetero

India

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

DIA 2025

Not Confirmed

04

Cambrex Corporation

U.S.A

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

DIA 2025

Not Confirmed

05

Cambrex Corporation

U.S.A

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

DIA 2025

Not Confirmed

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

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

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

API | Excipient name

Berotralstat Hydrochloride

Synonyms

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

Cas Number

1809010-50-1

Unique Ingredient Identifier (UNII)

XZA0KB1BDQ

About Berotralstat Hydrochloride

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 [INN] Manufacturers

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

Berotralstat [INN] Suppliers

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

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

Berotralstat [INN] Manufacturers | Traders | Suppliers

We have 4 companies offering Berotralstat [INN]

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.