Active Pharmaceutical Ingredient

Alprazolam API Manufacturer & Supplier in India

Also known as: Xanax

CAS: 28981-97-7 Anxiolytic / Benzodiazepine USP / BP / IP Schedule-H Regulated
Alprazolam API Manufacturer India | Mediocon Inc
Alprazolam — Pharmaceutical Grade API

Product Overview

CAS No: 28981-97-7  |  MF: C₁₇H₁₃ClN₄  |  MW: 308.76 g/mol

Alprazolam is a short-acting benzodiazepine used in the management of anxiety disorders, panic disorder, and anxiety associated with depression. It acts by enhancing GABAergic neurotransmission. Mediocon Inc supplies pharmaceutical-grade Alprazolam meeting USP, BP, and IP standards under Schedule-H regulations.

Key Features

  • Short-acting benzodiazepine anxiolytic
  • USP/BP/IP compliant quality
  • GABA-A receptor positive modulator
  • Supplied with full regulatory documentation

Applications

  • Generalized anxiety disorder tablets
  • Panic disorder formulations
  • Anxiety-associated depression treatment
  • Immediate release & XR tablets

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 NameAlprazolam
Also Known AsXanax
CAS Number28981-97-7
Molecular FormulaC₁₇H₁₃ClN₄
Molecular Weight308.76 g/mol
CategoryBenzodiazepine / Anxiolytic
AppearanceWhite Crystalline Powder
GradeUSP / BP / IP

Analytical Specifications

ParameterSpecification
Assay98.0% – 101.5%
Loss on DryingNMT 0.5%
Melting Point225°C – 228°C
Heavy MetalsNMT 10 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing1 kg amber glass bottles / 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 Alprazolam (CAS 28981-97-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Alprazolam 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 — Alprazolam API

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