Simeprevir API Manufacturer India

High-Quality Active Pharmaceutical Ingredient for Antiviral Formulations

Swapnroop Pharma  ·  WHO-GMP Certified  ·  +91 87670 62101
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Simeprevir API Manufacturer India

Product Specifications

Product Name: Simeprevir API
CAS Number: 923604-59-5
Category: Active Pharmaceutical Ingredient
Grade: IP / BP / EP / USP
Appearance: White to off-white crystalline powder
Standards: IP / BP / EP / USP compliant

Detailed 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)2.0 – 4.0
Individual Impurity≤ 0.5%
Total Impurities≤ 1.5%

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WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries

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Simeprevir API (CAS No: 923604-59-5)

High-Quality Active Pharmaceutical Ingredient for Antiviral Formulations

Our Simeprevir supply program is built around repeatable batch quality, responsive communication, and practical support for formulation teams and procurement teams alike.

Our manufacturing and supply approach for Simeprevir emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.

Before approving a new source, most formulation teams review Simeprevir for assay consistency, impurity profile, and the completeness of supporting documentation — all of which we prioritise.

Key Features

  • Quality checks aligned with pharmacopoeial requirements
  • Documentation support aligned with customer qualification needs
  • Batch-to-batch consistency focused for commercial supply
  • Bulk packaging options designed for safe storage and dispatch

Applications

  • Suitable for formulation development and scale-up studies
  • Used by pharmaceutical buyers seeking consistent raw material supply and documentation coordination
  • Can support commercial procurement, validation batches, and routine production programs
  • Supports manufacturers working on related therapeutic dosage forms

Why Choose Us

  • Focus on repeatability, supply continuity, and practical business support
  • Bulk packaging and logistics support for domestic and export dispatch
  • Structured documentation assistance for buyer evaluation
  • WHO-GMP aligned processes across sourcing and dispatch

Packaging & Supply

We offer Simeprevir in pharma-oriented packaging formats including HDPE or fiber drum options with inner protection layers, helping maintain handling quality during storage, shipping, and routine supply movement.

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Frequently Asked Questions about Simeprevir API

What is the CAS number for Simeprevir API?

The CAS number for Simeprevir API is 923604-59-5. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.

What pharmacopeial grades is Simeprevir API available in?

Simeprevir API is available in IP, BP, EP, and USP pharmacopeial grades with quality testing per pharmacopoeial and in-house specifications. All batches come with full CoA and MSDS.

What is the MOQ and lead time for Simeprevir API?

Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply is available for larger volumes.

Is DMF documentation available for Simeprevir API?

Yes, Swapnroop provides full DMF-grade documentation for Simeprevir API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.

Does Swapnroop export Simeprevir API internationally?

Yes, Swapnroop exports Simeprevir API to 40+ countries including the USA, UK, UAE, Germany, Australia, South Africa, Nigeria, Kenya, Brazil, and Southeast Asian markets. We provide full export documentation and regulatory support.

Simeprevir API Bulk Supplier in India

For companies evaluating Simeprevir API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.

Simeprevir API Manufacturer for Commercial Sourcing

Our team works with buyers who need Simeprevir API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.