Active Pharmaceutical Ingredient

Milnacipran API Manufacturer & Supplier in India

Also known as: Savella; Ixel

CAS: 92623-85-3 SNRI Antidepressant / Fibromyalgia IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Milnacipran API — Mediocon Inc
Milnacipran — Pharmaceutical Grade API

Product Overview

CAS No: 92623-85-3  |  MF: C₁₅H₂₂N₂O  |  MW: 246.35 g/mol

Milnacipran is a pharmaceutical-grade active ingredient classified as SNRI Antidepressant / Fibromyalgia. Mediocon Inc supplies high-purity Milnacipran API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Dual serotonin-norepinephrine reuptake inhibitor (SNRI)
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Fibromyalgia
  • Major depressive disorder
  • Chronic pain 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 NameMilnacipran
Also Known AsSavella; Ixel
CAS Number92623-85-3
Chemical Name(1R,2S)-rel-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropane-1-carboxamide
Molecular FormulaC₁₅H₂₂N₂O
Molecular Weight246.35 g/mol
CategorySNRI Antidepressant / Fibromyalgia
AppearanceWhite crystalline powder
SolubilityFreely soluble in water
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
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 Milnacipran (CAS 92623-85-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Milnacipran 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 — Milnacipran API

What is the minimum order quantity for Milnacipran API?
Mediocon Inc supplies Milnacipran 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 Milnacipran does Mediocon supply?
We supply Milnacipran 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 Milnacipran API?
Every shipment of Milnacipran 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 Milnacipran bulk orders?
Standard lead time for Milnacipran 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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