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Berotralstat Hydrochloride bulk supplier for pharma manufacturers

Berotralstat Hydrochloride 150 mg,110 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 150 mg,110 mg

Reference Brands: Orladeyo (USA)

Category: Immune Disorder

Berotralstat Hydrochloride is a Immune Disorder product available as Tablets in strengths 150 mg,110 mg. It corresponds to the reference brand Orladeyo (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

Product Description:

Berotralstat, marketed under the brand name Orladeyo, is an oral plasma kallikrein inhibitor used for the prophylactic treatment of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. HAE is a rare genetic disorder characterized by recurrent episodes of severe swelling in various parts of the body, including the face, extremities, gastrointestinal tract, and airway. These attacks can be painful, debilitating, and potentially life-threatening when the airway is involved.

By selectively inhibiting plasma kallikrein, berotralstat reduces the excessive production of bradykinin, a key mediator responsible for the swelling and pain experienced during HAE attacks. This mechanism helps prevent the onset of HAE episodes, improving patient quality of life and providing a convenient, once-daily oral therapy compared to injectable alternatives. Berotralstat represents a targeted approach for long-term disease management, offering patients effective prophylaxis against recurrent hereditary angioedema attacks.

Berotralstat Hydrochloride — third party manufacturing & bulk supply

Berotralstat Hydrochloride 150 mg,110 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Berotralstat Hydrochloride listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Berotralstat hydrochloride is used for the prophylactic treatment of hereditary angioedema (HAE) to reduce the frequency of angioedema attacks in adults and adolescents aged 12 years and older.

Berotralstat hydrochloride is a synthetic small-molecule oral plasma kallikrein inhibitor formulated as a hydrochloride salt.

The trade name of berotralstat hydrochloride is Orladeyo.

Berotralstat hydrochloride (Orladeyo) is developed and marketed by BioCryst Pharmaceuticals, Inc.

The generic name of Berotralstat Hydrochloride is berotralstat hydrochloride.

The brand name of Berotralstat Hydrochloride is Orladeyo.

Berotralstat hydrochloride is manufactured in GMP-compliant facilities in the USA and other regulated markets for global distribution.

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