WHO-GMP certified production with complete DMF support.
Availability: In Stock | CAS: 153439-40-8 | Grade: Medicinal.
Fexofenadine HCL API is a second-generation, non-sedating antihistamine that selectively blocks peripheral H1 receptors and is widely used in anti-allergy formulations due to its proven efficacy and safety profile. As a trusted manufacturer, we ensure consistent quality and global compliance.
Surya Life Sciences Ltd. is a leading Fexofenadine HCL manufacturer and pharmaceutical API manufacturer in India, delivering WHO-GMP certified production, DMF support, and consistent API quality for global pharmaceutical companies. We are also recognized as a reliable Fexofenadine Hydrochloride manufacturer in India, supplying to regulated and semi-regulated markets.
Our four WHO-GMP–approved manufacturing facilities, certified to ISO 9001:2015, operate in compliance with all statutory environmental and safety requirements. This ensures every batch consistently meets the highest quality standards your formulations demand.
Fexofenadine HCL API Key Specifications
| Attribute | Specification |
|---|
| Chemical Name | Fexofenadine Hydrochloride |
| CAS | 153439-40-8 |
| Category | Antihistamine (H1 Receptor Antagonist) |
| Therapeutic Use | Anti-allergic; treatment of allergic rhinitis and chronic urticaria |
| Molecular Formula | C₃₂H₃₉NO₄·HCl |
| Molecular Weight | ~538.13 g/mol |
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water; soluble in methanol |
| Purity | ≥ 99.0% (as per pharmacopeial limits) |
| Shelf Life | 60 months (re-test period) |
| Available Grades | Medicinal |
Why Choose Surya Life Sciences as Your Fexofenadine HCL Manufacturer?
As a trusted Fexofenadine HCL manufacturer and antihistamine API manufacturer, Surya Life Sciences offers quality you can rely on, documentation that stands up to scrutiny, and a supply you don’t have to chase. Here’s why global companies keep coming back to us:
Regulatory-Ready Documentation & DMF Support
Regulatory reviews move faster when the data is complete, current, and well-structured. We provide comprehensive technical and regulatory documentation. Designed to support development programs as well as global market filings, including:
- Drug Master File (DMF) support
- CEP / pharmacopeial compliance data (where applicable)
- Method validation data, stability data, and batch-specific CoA
Reliable Stock Availability & Supply Continuity
Our production planning and inventory controls are designed to ensure uninterrupted supply for ongoing programs:
- Stock and made-to-order supply options
- Typical dispatch timelines of 7 days, subject to batch availability
- Long-term supply planning for commercial customers
Easy Ordering & Reasonable Pricing
Our ordering options are aligned to different stages of product development. You can easily order:
- R&D samples
- Pilot and clinical batches
- Commercial supply at reasonable prices.
Orders are processed through a simple approval workflow. Delivery timelines are defined upfront based on batch size and project stage.
Certified Quality & Compliance
Our manufacturing and quality systems are aligned with internationally recognised standards:
- WHO-GMP–approved facilities
- ISO 9001:2015
- ISO 14001:2004
- OHSAS 18001:1999
- Compliance with global pharmacopeial and environmental standards
Bulk Supply and Customization
As a high-capacity Fexofenadine HCL manufacturer and bulk API supplier in India, we offer a supply capacity of up to 1,000 kilograms per day. This reflects the ability to deliver consistently and at scale across global markets.
Customization Options:
- Micronized and non-micronized grades of Fexofenadine Hydrochloride
- Varied batch sizes to match project needs
- Customized packaging formats for regulatory, safety, or logistics requirements
Clinical Uses & Industry Applications of Fexofenadine Hydrochloride API
Fexofenadine HCL API is indicated for the treatment of a wide range of allergic conditions, including:
Allergic rhinitis (seasonal and perennial)
Seasonal allergies caused by pollen, dust, and environmental allergens
Chronic idiopathic urticaria (hives)
Key industry applications of Fexofenadine Hydrochloride API include:
Finished Dosage Form Manufacturing
Used by pharmaceutical manufacturers and generic drug API suppliers for the production of solid oral dosage forms such as tablets and capsules in regulated markets. This makes us a preferred Fexofenadine HCL manufacturer for pharmaceutical companies worldwide.
Generic Drug Development Programs
Integrated into ANDA / generic formulation pipelines where consistent quality, regulatory documentation, and batch-to-batch reproducibility are critical.
Contract Manufacturing & Private Label Supply
Supplied to CDMOs and third-party manufacturers supporting branded and private-label antihistamine product portfolios.
Formulation R&D and Process Optimisation
Utilised during formulation trials, scale-up studies, and bioequivalence development requiring stable physicochemical performance.
Regulated Export & International Supply Chains
Applied in export-oriented manufacturing, where compliance with pharmacopeial standards and global regulatory expectations is essential.
Storage, Packaging & Handling Information
Storage
Store in a cool, dry place away from light and moisture
Packaging
HDPE drums with double LDPE liners or customized pharmaceutical-grade packaging
Handling
Handle in accordance with GMP guidelines and MSDS recommendations. Wear Personal Protective Equipment (PPE). Avoid direct contact with skin, eyes, nose, and clothing.
Request Batch Details, Pricing, and Availability for Fexofenadine HCL API
Connect with our experts for pricing, availability, technical documentation, and regulatory assistance.
FAQs
Is Fexofenadine Hydrochloride API pharmacopeia compliant?
Fexofenadine Hydrochloride API is described in major pharmacopeias, including IP, BP, USP, and EP, with defined specifications for identity, purity, and quality.
Are DMFs applicable to regulated and semi-regulated markets?
Yes. Surya Life Sciences prepares and supports Drug Master Files (DMFs) and associated regulatory documentation for use in both regulated and semi-regulated markets, subject to regional authority requirements.
What is the typical delivery time for bulk API orders?
Surya Life Sciences typically dispatches Fexofenadine Hydrochloride API orders within 7 days of order confirmation, subject to batch availability and final quality release. Exact timelines are confirmed at the order stage.
What is the minimum order quantity (MOQ) for Fexofenadine Hydrochloride API?
The MOQ for Fexofenadine Hydrochloride API is 200 kg. API-specific MOQs are listed on the respective product pages and can be reconfirmed by our commercial team.