Loratadine API Manufacturer India

High-Quality Non-Sedating Antihistamine API for Allergic Rhinitis Formulations

Quick Answer: Loratadine API (CAS 79794-75-5) is an Antihistamine (Non-Sedating) manufactured and supplied in bulk by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified facility in Maharashtra, India. It is available in IP / BP / EP / USP grades with full CoA, MSDS, and DMF documentation, MOQ from 1 kg (sample) to 25 kg+ (commercial), standard lead time 2–4 weeks, and export support to 40+ countries.

Reviewed by Swapnroop Quality Assurance Team · Last updated
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Loratadine API Manufacturer India

Product Specifications

Product Name: Loratadine API
CAS Number: 79794-75-5
Category: Antihistamine (Non-Sedating)
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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What is Loratadine API? (CAS No: 79794-75-5)

High-Quality Non-Sedating Antihistamine API for Allergic Rhinitis Formulations

Loratadine API is an Antihistamine (Non-Sedating) sold in bulk as an Active Pharmaceutical Ingredient (API), positioned for companies seeking a dependable ingredient source backed by organized quality systems and scalable supply support.

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

Loratadine 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 customer qualification needs
  • Batch-to-batch consistency focused for 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 non-sedating antihistamine dosage forms.

How to Order Loratadine API

  1. Send an enquiry via WhatsApp, email, or phone with your required quantity and grade.
  2. Receive product specifications, a CoA sample, and a formal bulk quote from our team.
  3. Confirm order terms, request samples if needed, and finalize documentation (MSDS, DMF, regulatory dossier).
  4. Receive scheduled dispatch with export documentation for domestic or international delivery.

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 Loratadine API 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 Loratadine API

What is Loratadine API used for?

Loratadine API is an Antihistamine (Non-Sedating) supplied in bulk to licensed pharmaceutical manufacturers, who use it as the active ingredient to formulate finished dosage forms, subject to regulatory approval in the destination market.

What is the CAS number for Loratadine API?

The CAS number for Loratadine API is 79794-75-5. It is an Active Pharmaceutical Ingredient (API) manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified company in Maharashtra, India.

What pharmacopeial grades is Loratadine API available in?

Loratadine API is available in IP / BP / EP / USP pharmacopeial grades with HPLC purity ≥98.0–102.0%. All batches come with full CoA, MSDS, and pharmacopeial identification testing.

What is the MOQ and lead time for Loratadine 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 Loratadine API?

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

Does Swapnroop export Loratadine API internationally?

Yes, Swapnroop exports Loratadine 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.

Loratadine API Bulk Supplier in India

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

Loratadine API Manufacturer for Commercial Sourcing

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