Active Pharmaceutical Ingredient

Alpelisib API Manufacturer & Supplier in India

Also known as: Piqray

CAS: 1217486-61-7 PI3K Inhibitor / Oncology GMP Standard Bulk Supply Available
Alpelisib API Manufacturer India | Mediocon Inc
Alpelisib — Pharmaceutical Grade API

Product Overview

CAS No: 1217486-61-7  |  MF: C₁₉H₂₂F₃N₅O₂S  |  MW: 441.47 g/mol

Alpelisib is a phosphatidylinositol-3-kinase alpha (PI3Kα) inhibitor indicated for the treatment of PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer. Mediocon Inc supplies pharmaceutical-grade Alpelisib for licensed oncology API manufacturers.

Key Features

  • Selective PI3Kα inhibitor
  • GMP compliant manufacturing
  • Used in breast cancer targeted therapy
  • Effective against PIK3CA mutations

Applications

  • HR+/HER2- advanced breast cancer
  • Combination fulvestrant therapy
  • PIK3CA mutation-positive cancer
  • Targeted oncology 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

Product Specifications

Product NameAlpelisib
Also Known AsPiqray
CAS Number1217486-61-7
Molecular FormulaC₁₉H₂₂F₃N₅O₂S
Molecular Weight441.47 g/mol
CategoryPI3K Inhibitor / Oncology Agent
AppearanceWhite to Off-white Powder
GradeIn-house GMP Standard

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 1.0%
Melting PointN/A
Heavy MetalsNMT 10 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing1 kg foil pouches / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Alpelisib (CAS 1217486-61-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Alpelisib is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Alpelisib API

What is the minimum order quantity for Alpelisib API?
Mediocon Inc supplies Alpelisib with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Alpelisib does Mediocon supply?
We supply Alpelisib conforming to In-house GMP Standard pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Alpelisib API?
Every shipment of Alpelisib comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Alpelisib bulk orders?
Standard lead time for Alpelisib is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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