Active Pharmaceutical Ingredient

Penciclovir API Manufacturer & Supplier in India

Also known as: BRL 39123; Denavir (brand); Vectavir (brand)

GMP Certified IP / BP / EP / USP Antiviral / Nucleoside Analogue Aurangabad, India
Penciclovir API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Penciclovir IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 39809-25-1

Product Overview

Penciclovir is a high-purity antiviral API classified as a purine nucleoside analogue with potent activity against Herpes simplex virus (HSV-1 and HSV-2) and Varicella zoster virus (VZV). Mediocon Inc manufactures GMP-compliant Penciclovir at its Aurangabad, Maharashtra facility. The compound is selectively phosphorylated by viral thymidine kinase and then inhibits viral DNA polymerase, providing targeted antiviral activity with minimal effects on host cells.

Therapeutic Applications
  • Topical treatment of recurrent herpes labialis (cold sores) caused by HSV-1
  • Genital herpes (HSV-2) management in combination formulations
  • Varicella zoster virus (VZV) infections
  • Antiviral prophylaxis in immunocompromised patients

Technical Specifications

ParameterSpecification
CAS Number39809-25-1
Molecular FormulaC₁₀H₁₅N₅O₃
Molecular Weight253.26 g/mol
GradeIP / BP / EP / USP
CategoryAntiviral / Nucleoside Analogue
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPENC/24032026
Mfg DateMAR 2026
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 Penciclovir — CAS 39809-25-1 (CAS 39809-25-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Penciclovir — CAS 39809-25-1 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 — Penciclovir — CAS 39809-25-1 API

What is the minimum order quantity for Penciclovir — CAS 39809-25-1 API?
Mediocon Inc supplies Penciclovir — CAS 39809-25-1 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 Penciclovir — CAS 39809-25-1 does Mediocon supply?
We supply Penciclovir — CAS 39809-25-1 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 Penciclovir — CAS 39809-25-1 API?
Every shipment of Penciclovir — CAS 39809-25-1 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 Penciclovir — CAS 39809-25-1 bulk orders?
Standard lead time for Penciclovir — CAS 39809-25-1 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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