Active Pharmaceutical Ingredient

Telbivudine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

CAS: 3424-98-4 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Telbivudine API Manufacturer & Bulk Supplier in India | MEDIOCON INC — Mediocon Inc
Telbivudine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

Product Overview

CAS No: 3424-98-4 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Telbivudine API Manufacturer & Bulk Supplier

Telbivudine API is a high-purity pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in the formulation of antiviral medications for the treatment of chronic Hepatitis B virus (HBV) infections. As a nucleoside analogue with excellent antiviral activity, Telbivudine API is recognized for its high purity, stability, and consistent pharmaceutical performance, making it suitable for regulated pharmaceutical manufacturing, formulation development, analytical testing, and research applications.

MEDIOCON INC is a trusted Telbivudine API manufacturer and bulk supplier in India, supplying premium-quality pharmaceutical ingredients to pharmaceutical companies, contract manufacturing organizations (CMOs), formulation developers, research laboratories, and distributors across global markets. Our advanced manufacturing facilities operate under stringent GMP-compliant processes to ensure consistent quality, batch-to-batch reproducibility, and compliance with international pharmaceutical standards.

At MEDIOCON INC, every batch of Telbivudine API undergoes comprehensive analytical testing using validated quality control methods. Critical parameters such as identity, assay, impurity profile, moisture content, residual solvents, and stability are carefully evaluated to ensure the product consistently meets the highest pharmaceutical specifications before commercial release.

Our Telbivudine API is available in IP, BP, EP, and USP grades, making it suitable for antiviral pharmaceutical formulations, generic drug manufacturing, formulation development, quality control laboratories, analytical testing, stability studies, and pharmaceutical research. We also provide complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and other supporting documents, enabling smooth procurement and regulatory compliance.

With a strong commitment to quality, innovation, and customer satisfaction, MEDIOCON INC has established itself as a reliable global supplier of pharmaceutical raw materials. Our secure packaging, competitive pricing, efficient logistics network, and dedicated technical support enable us to deliver premium-quality Telbivudine API to customers worldwide with confidence.

If you are searching for a dependable Telbivudine API manufacturer, exporter, and bulk supplier, MEDIOCON INC offers premium pharmaceutical ingredients backed by consistent quality, complete documentation, and timely worldwide delivery. Contact our technical sales team today for quotations, technical specifications, or customized bulk supply solutions.

Product Specifications

Product NameTelbivudine API Manufacturer & Bulk Supplier in India | MEDIOCON INC
CAS Number3424-98-4
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)As per Manufacturer Specification
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.5%
Water ContentNMT 1.0%
Specific RotationAs per Pharmacopoeial Standard
Melting PointAs per Manufacturer Specification
SolubilityFreely Soluble in Water; Slightly Soluble in Methanol

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 Telbivudine API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 3424-98-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Telbivudine API Manufacturer & Bulk Supplier in India | MEDIOCON INC 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Telbivudine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

What is Telbivudine API used for?
Telbivudine API is used in the manufacture of antiviral medicines for the treatment of chronic Hepatitis B virus (HBV) infections.
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