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Berotralstat Hydrochloride bulk supplier for pharma manufacturers

Berotralstat Hydrochloride Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 150 mg,110 mg

Reference Brands: Orladeyo (USA)

Category: Immune Disorder

Berotralstat Hydrochloride is available in Tablets and strengths such as 150 mg,110 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Berotralstat Hydrochloride is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Berotralstat Hydrochloride can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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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.

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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.

Yes, Berotralstat Hydrochloride is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Berotralstat Hydrochloride is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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