Nafcillin API Manufacturer in India

WHO-GMP Certified Active Pharmaceutical Ingredient Supplier

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

Product Specifications

Product Name: Nafcillin API
CAS Number: 147-52-4
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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Nafcillin API (CAS No: 147-52-4)

WHO-GMP Certified Active Pharmaceutical Ingredient Supplier

Nafcillin API (CAS 147-52-4) is an active pharmaceutical ingredient used in the manufacture of pharmaceutical formulations. As a leading Nafcillin API supplier and manufacturer in India, Swapnroop Drugs & Pharmaceuticals ensures high purity, consistent quality, and full compliance with international pharmacopeial standards for global regulated and semi-regulated markets.

Pharmaceutical companies sourcing Nafcillin API evaluate HPLC purity (≥98.0%), impurity profile control (ICH Q3A compliant), residual solvent content (ICH Q3C), and polymorphic form consistency. Batch-to-batch reproducibility in particle size distribution (D90, D50) is critical for consistent dissolution performance and tablet compressibility in downstream formulation.

Swapnroop Drugs and Pharmaceuticals supplies Nafcillin API from our WHO-GMP certified Aurangabad facility with complete IP/BP/EP/USP pharmacopeial compliance. We support ANDA/NDA filing through DMF-referenced documentation, provide fresh monthly batches with validated shelf life, and export to 25+ countries with full regulatory dossier support.

Key Features

  • HPLC purity ≥98.0–102.0% with full pharmacopeial identification (IR, HPLC, mass spec)
  • Comprehensive impurity profiling per ICH Q3A with genotoxic impurity screening per ICH M7
  • Available in multiple pharmacopeial grades: IP, BP, EP, USP
  • WHO-GMP certified Aurangabad facility with validated manufacturing and full batch traceability

Applications

  • Tablet, capsule, and oral liquid pharmaceutical formulations
  • Fixed-dose combination (FDC) products for domestic and export markets
  • Generic ANDA/NDA manufacturing programs for USFDA and EMA regulated markets
  • WHO prequalification programs and essential medicines list formulations

Why Choose Swapnroop for Nafcillin API?

  • WHO-GMP certified Aurangabad facility with audited manufacturing documentation
  • DMF filing support for USFDA, EMA, and CDSCO regulated markets
  • Fresh monthly batch supply with validated 36-month stability data from ICH storage conditions
  • Dedicated account management for pharmaceutical procurement and regulatory programs

Packaging & Supply

Nafcillin API is supplied in triple-layer HDPE drums (5 kg, 10 kg, 25 kg) with moisture barrier inner bags and nitrogen purge to preserve API purity and pharmacopeial compliance during storage and international transit.

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Frequently Asked Questions about Nafcillin API

What is the CAS number for Nafcillin API?

The CAS number for Nafcillin API is 147-52-4. Please verify the exact salt or hydrate form you require as different forms carry distinct CAS numbers"faq-item">

What purity and grade is Nafcillin API available in?

Nafcillin API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC assay 98.0–102.0%, full impurity profiling per ICH Q3A, and pharmacopeial identification testing (IR, HPLC).

What is the MOQ and lead time for Nafcillin API?

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

Is DMF documentation available for Nafcillin API?

Yes, Swapnroop provides full DMF-grade documentation for Nafcillin API including CoA, MSDS, impurity report, stability data, and complete regulatory dossier support for USFDA, EMA, and CDSCO submissions.

Nafcillin API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Nafcillin API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Nafcillin API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Nafcillin API Exporter from India – Regulatory Filing Support

As a Nafcillin API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Nafcillin API pricing, samples, and sourcing support.