Active Pharmaceutical Ingredient

Alendronate API Manufacturer & Supplier in India

Also known as: Fosamax

CAS: 121268-17-5 Bisphosphonate / Bone Health USP / BP Bulk Supply Available
Alendronate API Manufacturer India | Mediocon Inc
Alendronate — Pharmaceutical Grade API

Product Overview

CAS No: 121268-17-5  |  MF: C₄H₁₃NO₇P₂  |  MW: 325.12 g/mol

Alendronate (Alendronic acid) is a bisphosphonate used for the treatment and prevention of osteoporosis in postmenopausal women and men. It inhibits osteoclast-mediated bone resorption. Mediocon Inc supplies pharmaceutical-grade Alendronate sodium meeting USP and BP standards.

Key Features

  • Potent bisphosphonate antiresorptive
  • USP/BP compliant quality
  • Inhibits osteoclast activity
  • Suitable for weekly tablet formulations

Applications

  • Postmenopausal osteoporosis tablets
  • Glucocorticoid-induced osteoporosis
  • Paget's disease of bone treatment
  • Male osteoporosis 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 NameAlendronate
Also Known AsFosamax
CAS Number121268-17-5
Molecular FormulaC₄H₁₃NO₇P₂
Molecular Weight325.12 g/mol
CategoryBisphosphonate / Anti-osteoporotic
AppearanceWhite Crystalline Powder
GradeUSP / BP

Analytical Specifications

ParameterSpecification
Assay98.0% – 101.0%
Loss on DryingNMT 1.0%
Melting PointN/A
Heavy MetalsNMT 10 ppm
pH4.0 – 5.0 (1% solution)
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 Alendronate (CAS 121268-17-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Alendronate 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 — Alendronate API

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