Zinc Oxide API Manufacturer India

High-Quality Active Pharmaceutical Ingredient for Dermatological and Topical Formulations

Zinc Oxide API (CAS 1314-13-2) is an active pharmaceutical ingredient in the Dermatology / Topical API category, manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified facility in Chhatrapati Sambhaji Nagar (Aurangabad), Maharashtra, India. It is supplied in IP/BP/EP/USP pharmacopeial grades, with MOQ starting at 1 kg for sampling and 25 kg for commercial bulk orders, full CoA/MSDS documentation, and export support to USA, UK, Germany, UAE, Saudi Arabia, Brazil, South Africa, Nigeria, Kenya, Australia, and Southeast Asian markets.

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Zinc Oxide API Manufacturer India

Product Specifications

Product Name: Zinc Oxide API
CAS Number: 1314-13-2
Category: Dermatology / Topical API
Grade: IP / BP / EP / USP
Appearance: White to off-white amorphous powder
Standards: IP / BP / EP / USP compliant

Detailed Specifications

ParameterSpecification
AppearanceWhite to off-white amorphous 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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Zinc Oxide API (CAS No: 1314-13-2)

High-Quality Active Pharmaceutical Ingredient for Dermatological and Topical Formulations

Zinc Oxide API is positioned for companies seeking a dependable active pharmaceutical ingredient source backed by organized quality systems and scalable supply support.

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

Zinc Oxide is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.

Key Features

  • Documentation support aligned with topical-formulation qualification needs
  • Batch-to-batch consistency focused on commercial supply
  • Bulk packaging options designed for safe storage and dispatch
  • Supply planning suited to domestic and export demand

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 cream, ointment, gel, and topical dosage forms

Quality & Regulatory Compliance

Zinc Oxide API is manufactured under WHO-GMP certified processes with in-house quality control covering identification, assay, related substances, and heavy-metal testing for every batch. Each shipment is released against a Certificate of Analysis (CoA) and Material Safety Data Sheet (MSDS), with DMF-grade dossier support (stability data and Genotoxic Impurity Report) available for USFDA, EMA, and CDSCO regulatory submissions.

Global Export Reach

Swapnroop exports Zinc Oxide API to pharmaceutical buyers across USA, UK, Germany, UAE, Saudi Arabia, Brazil, South Africa, Nigeria, Kenya, Australia, and Southeast Asian markets, with export documentation, phytosanitary/regulatory paperwork, and logistics coordination handled for both sea and air freight consignments.

Why Choose Us

  • Consistent commercial communication and responsive quotation support
  • 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

Packaging & Supply

We offer Zinc Oxide 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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How to Order Zinc Oxide API

1. Enquire

Share your required quantity and pharmacopeial grade via WhatsApp or email.

2. Documentation

We share CoA, MSDS, and applicable DMF-grade documents for evaluation.

3. Sample/Order

Confirm a 1 kg sample or place a commercial bulk order (25 kg+).

4. Dispatch

Standard lead time is 2–4 weeks with full export documentation handled.

What Buyers Say

★★★★★

“Smooth procurement experience for Zinc Oxide API — responsive communication and well-organized documentation.”

— Formulation Development Lead

★★★★★

“WHO-GMP certified quality with excellent technical support. Zinc Oxide API meets all pharmacopoeial specifications.”

— Quality Assurance Head

Related Pharmaceutical APIs

Other APIs available from Swapnroop Pharma

GLP-1 APITirzepatideImmunology APITralokinumabGastrointestinal APIPlecanatideAntiviral APIRemdesivirImmunology APIDupilumabEndocrine APITolvaptan

Frequently Asked Questions about Zinc Oxide API

What is the CAS number for Zinc Oxide API?

The CAS number for Zinc Oxide API is 1314-13-2. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.

What pharmacopeial grades is Zinc Oxide API available in?

Zinc Oxide API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC-verified purity. All batches include full CoA, MSDS, and pharmacopeial identification testing.

What is the MOQ and lead time for Zinc Oxide API?

Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply of Zinc Oxide API. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility.

Is DMF documentation available for Zinc Oxide API?

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

What particle size grade of Zinc Oxide is available for topical formulations?

Particle-size specifications for Zinc Oxide can be discussed based on the buyer's topical formulation requirements. Please share your target specification when requesting a quote.

Zinc Oxide API Bulk Supplier in India

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

Zinc Oxide API Manufacturer for Commercial Sourcing

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