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Sepiapterin bulk supplier for pharma manufacturers

Sepiapterin Suppliers & Bulk Manufacturers

Available Forms: Tablets / oral powder

Available Strengths: 1000 mg, 250 mg

Reference Brands: Sephience (USA/EU)

Category: Orphan Drugs

Sepiapterin is available in Tablets / oral powder and strengths such as 1000 mg, 250 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, Sepiapterin 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)

Sepiapterin 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:

Sepiapterin is a phenylalanine hydroxylase activator used for the treatment of hyperphenylalaninemia, including phenylketonuria (PKU). Marketed under the brand name Sephience, Sepiapterin supports metabolic control in patients who are unable to adequately process phenylalanine due to enzymatic deficiency. It works by enhancing the activity of phenylalanine hydroxylase, a key enzyme responsible for converting phenylalanine into tyrosine, thereby helping to reduce elevated blood phenylalanine levels.

Sepiapterin is a naturally occurring metabolite synthesized in the human body and serves as a biochemical precursor in the salvage pathway leading to the formation of tetrahydrobiopterin (BH4). BH4 is an essential cofactor required for the normal metabolism of phenylalanine and plays a critical role in the synthesis of neurotransmitter precursors derived from tyrosine and tryptophan, including dopamine and serotonin.

By restoring metabolic balance and improving enzymatic function, Sepiapterin provides a targeted therapeutic option for patients with disorders of phenylalanine metabolism. It is intended for long-term management and may be used alongside dietary control and other supportive treatments to achieve optimal metabolic outcomes.

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Frequently Asked Questions

Sepiapterin is used for the treatment of phenylketonuria (PKU) to help lower and control elevated blood phenylalanine levels.

Sepiapterin is a synthetically manufactured compound that serves as a biochemical precursor to tetrahydrobiopterin (BH4).

The trade name of Sepiapterin is Sephience.

Sepiapterin (Sephience) is developed and manufactured by PTC Therapeutics.

The generic name of Sephience is Sepiapterin dihydrochloride.

The brand name of Sepiapterin is Sephience.

Sepiapterin is manufactured at PTC Therapeutics’ approved pharmaceutical manufacturing facilities, operating under international GMP and regulatory standards.

Yes, Sepiapterin 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, Sepiapterin 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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