Active Pharmaceutical Ingredient

Penciclovir Sodium — CAS 97845-62-0 API Manufacturer & Supplier in India

Also known as: Sodium Penciclovir; Penciclovir Sodium Salt

GMP Certified IP / BP / EP / USP Antiviral / Nucleoside Analogue Aurangabad, India
Penciclovir Sodium API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Penciclovir Sodium IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 97845-62-0

Product Overview

Penciclovir Sodium is the sodium salt form of the antiviral nucleoside analogue Penciclovir. Mediocon Inc manufactures this high-purity API at its GMP-certified facility in Aurangabad, Maharashtra, India. The sodium salt form offers improved solubility properties suitable for parenteral and topical formulations. It retains the full antiviral efficacy against Herpes simplex virus (HSV-1, HSV-2) and Varicella zoster virus through selective viral thymidine kinase phosphorylation.

Therapeutic Applications
  • Parenteral and topical antiviral formulations against HSV-1 and HSV-2
  • Enhanced solubility applications requiring sodium salt form
  • Varicella zoster virus treatment formulations
  • Antiviral pharmaceutical manufacturing

Technical Specifications

ParameterSpecification
CAS Number97845-62-0
Molecular FormulaC₁₀H₁₄N₅NaO₃
Molecular Weight275.24 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 NoPENCS/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 Sodium — CAS 97845-62-0 (CAS 97845-62-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Penciclovir Sodium — CAS 97845-62-0 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 Sodium — CAS 97845-62-0 API

What is the minimum order quantity for Penciclovir Sodium — CAS 97845-62-0 API?
Mediocon Inc supplies Penciclovir Sodium — CAS 97845-62-0 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 Sodium — CAS 97845-62-0 does Mediocon supply?
We supply Penciclovir Sodium — CAS 97845-62-0 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 Sodium — CAS 97845-62-0 API?
Every shipment of Penciclovir Sodium — CAS 97845-62-0 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 Sodium — CAS 97845-62-0 bulk orders?
Standard lead time for Penciclovir Sodium — CAS 97845-62-0 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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