Active Pharmaceutical Ingredient

Sermorelin API Manufacturer & Supplier in India

Also known as: GHRH(1-29)-NH2 / Geref

GMP Certified IP / BP / EP / USP Growth Hormone Secretagogue / Peptide Aurangabad, India
Sermorelin API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sermorelin IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 135159-51-2

Product Overview

Sermorelin is a synthetic 29-amino acid peptide corresponding to the first 29 amino acids of the endogenous growth hormone-releasing hormone (GHRH). It stimulates the somatotrophs in the anterior pituitary to synthesize and release growth hormone. Used diagnostically to evaluate GH reserve and therapeutically for GH deficiency in both pediatric and adult patients. Mediocon Inc produces GMP-certified Sermorelin API at its Aurangabad manufacturing facility.

Therapeutic Applications
  • Growth hormone deficiency diagnosis
  • GH reserve evaluation
  • Pediatric short stature treatment
  • Therapeutic GH stimulation

Technical Specifications

ParameterSpecification
CAS Number135159-51-2
Molecular FormulaC₁₄₉H₂₄₆N₄₄O₄₂S
Molecular Weight3297.89 g/mol
GradeIP / BP / EP / USP
CategoryGrowth Hormone Secretagogue / Peptide
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support

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 Sermorelin — CAS 135159-51-2 (CAS 135159-51-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sermorelin — CAS 135159-51-2 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 — Sermorelin — CAS 135159-51-2 API

What is the minimum order quantity for Sermorelin — CAS 135159-51-2 API?
Mediocon Inc supplies Sermorelin — CAS 135159-51-2 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 Sermorelin — CAS 135159-51-2 does Mediocon supply?
We supply Sermorelin — CAS 135159-51-2 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 Sermorelin — CAS 135159-51-2 API?
Every shipment of Sermorelin — CAS 135159-51-2 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 Sermorelin — CAS 135159-51-2 bulk orders?
Standard lead time for Sermorelin — CAS 135159-51-2 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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