Active Pharmaceutical Ingredient

Saquinavir API Manufacturer & Supplier in India

Also known as: Invirase API; Saquinavir Mesylate

CAS: 149845-06-7 Antiretroviral BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Saquinavir API — Mediocon Inc
Saquinavir — Pharmaceutical Grade API

Product Overview

CAS No: 149845-06-7  |  MF: C₃₈H₅₀N₆O₅  |  MW: 670.84 g/mol

Saquinavir is a first-generation HIV protease inhibitor and active pharmaceutical ingredient used as part of combination antiretroviral therapy (ART) for HIV-1 infection. Mediocon Inc supplies high-purity Saquinavir API conforming to BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Saquinavir inhibits the HIV-1 protease enzyme, preventing viral polyprotein processing and thus the maturation of infectious HIV particles. It is used in combination with ritonavir (as a pharmacokinetic booster) in antiretroviral regimens.

Key Features

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

Applications

  • HIV-1 antiretroviral combination therapy
  • HIV protease inhibitor formulations
  • Boosted protease inhibitor regimens
  • Antiviral pharmaceutical research

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 NameSaquinavir
Also Known AsInvirase API; Saquinavir Mesylate
CAS Number149845-06-7
Molecular FormulaC₃₈H₅₀N₆O₅
Molecular Weight670.84 g/mol
CategoryHIV Protease Inhibitor — Antiretroviral
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; soluble in methanol
GradeBP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / 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 Saquinavir (CAS 149845-06-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Saquinavir 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 — Saquinavir API

What is the minimum order quantity for Saquinavir API?
Mediocon Inc supplies Saquinavir 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 Saquinavir does Mediocon supply?
We supply Saquinavir conforming to BP / EP / USP 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 Saquinavir API?
Every shipment of Saquinavir 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 Saquinavir bulk orders?
Standard lead time for Saquinavir 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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