Sapropterin (CAS 169939-94-0) API Manufacturer & Supplier in India

Sapropterin is a synthetic form of tetrahydrobiopterin (BH4), the natural cofactor for phenylalanine hydroxylase (PAH). Mediocon Inc supplies pharmaceutical-grade Sapropterin conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Sapropterin is indicated for the treatment of hyperphenylalaninaemia in patients with BH4-responsive Phenylketonuria (PKU). It activates residual PAH enzyme activity, reducing blood phenylalanine levels.

Key Features

• High-purity pharmaceutical grade API
• IP / BP / EP / USP compliant
• Full CoA and MSDS documentation
• GMP certified manufacturing facility

Applications

• Phenylketonuria (PKU) treatment
• Tetrahydrobiopterin replacement
• Rare metabolic disorder therapy
• Paediatric metabolic formulations

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Parameter	Specification
Assay	NLT 98.0%
Loss on Drying	NMT 0.5%
Heavy Metals	NMT 20 ppm
Residue on Ignition	NMT 0.1%
Microbial Limits	Complies with pharmacopoeia
Identification	IR, HPLC Compliant
Mfg Date	MAR 2025
Exp Date	FEB 2030
Packing	25 kg HDPE drums / as per requirement