Active Pharmaceutical Ingredient

Triptorelin API Manufacturer & Supplier in India

Also known as: Decapeptyl; AY-25650; D-Trp-6-LHRH

CAS: 57773-63-4GnRH Agonist APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Triptorelin API — Mediocon Inc
Triptorelin — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 57773-63-4  |  MF: C₆₄H₈₂N₁₈O₁₃  |  MW: 1311.46 g/mol

Triptorelin is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Triptorelin is a synthetic GnRH analogue (gonadotropin-releasing hormone agonist). Upon continuous administration, it down-regulates GnRH receptors, suppressing secretion of LH and FSH and consequentially reducing estrogen and testosterone levels. It is a key API in oncology and hormone-related disorder treatment.

Key Features

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

Applications

  • Advanced prostate cancer treatment
  • Endometriosis and uterine fibroids
  • Assisted reproductive technology (ART)
  • Precocious puberty management

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 NameTriptorelin
Also Known AsDecapeptyl; AY-25650; D-Trp-6-LHRH
CAS Number57773-63-4
Molecular FormulaC₆₄H₈₂N₁₈O₁₃
Molecular Weight1311.46 g/mol
CategoryGnRH Agonist / Antineoplastic Agent
AppearanceWhite to off-white powder
SolubilityFreely soluble in water; slightly soluble in methanol
GradeIP / BP / 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
Batch No.TRP/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
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 Triptorelin (CAS 57773-63-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Triptorelin 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 — Triptorelin API

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