FEXOFENADINE HYDROCHLORIDE

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FEXOFENADINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE
Chemical name: (±)-2-[4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidino]butyl]phenyl]-2-methylpropanoic acid.
Cas number: 153439-40-8
Molecular formula: C32H39NO4 · HCl
Molecular weight: 538.12
Therapeutic uses: Antihistamines
Specifications: IP/BP/USP
Appearance: White to Almost white crystal powder
Storage: Room temperature < 25°C
Therapeutic Class: Anti-histamine API

Description:

Fexofenadine Hydrochloride [Cas No. 153439-40-8] is a non-sedating second generation antihistamine API which is usually used in treatment of seasonal allergic rhinitis and chronic urticaria. Fexofenadine Hydrochloride delivers rapid and targeted relief from allergy symptoms such as itching, runny nose, sneezing as it acts as a selective H1-receptor antagonist.

Fexofenadine Hydrochloride is utilized as oral solid dosage forms for example: tablets, capsules and suspension that helps in providing fast action. It does not cross blood brain barrier and reduces the risk of anticholinergic , sedation and antidopaminergic effects. Fexofenadine Hydrochloride has a high tolerance level and has a good safety profile thus is preferred choice among all types of age group.

Chemox Pharma is a leading manufacturer of Fexofenadine Hydrochloride with its multipurpose ultramodern state-of-the-art facility at Dahej Industrial area of Gujarat, India. Chemox Pharma actively seeks global regulatory approvals and files Drug master files (DMFs). We aim to create high quality products and innovative APIs through continuous R&D following the latest WHO – GMP standards.

Applications

Sr. No. Description Application
1 Antihistamine API Anti-allergic tablet formulations
2 H1 receptor antagonist drug substance Allergic rhinitis treatment
3 Non-sedating antihistamine ingredient Chronic urticaria therapy
4 Anti-allergy pharmaceutical API Respiratory allergy formulations
5 Second-generation antihistamine Seasonal allergy medications

Fexofenadine Hydrochloride is widely used by pharmaceutical manufacturers in oral antihistamine formulations for allergy and urticaria management.

Product Specifications

Fexofenadine Hydrochloride API should be handled according to standard pharmaceutical material safety and industrial hygiene procedures. Appropriate protective measures must be followed during handling and processing of the antihistamine active pharmaceutical ingredient in GMP manufacturing environments.

  • Use appropriate personal protective equipment (PPE)

  • Avoid inhalation of powder and contact with skin or eyes

  • Handle in controlled pharmaceutical manufacturing areas

  • Follow GMP material handling procedures

  • Refer to Safety Data Sheet (SDS) for detailed safety guidance

This API is intended exclusively for pharmaceutical manufacturing and formulation use.

Mechanism of Actions

Fexofenadine Hydrochloride is a selective peripheral H1 histamine receptor antagonist that blocks the effects of histamine released during allergic reactions. By inhibiting histamine binding at H1 receptors in respiratory and dermal tissues, it reduces symptoms such as sneezing, itching, rhinorrhea, and urticaria. Its limited penetration into the central nervous system results in minimal sedation.

Safety Precautions

  • Handle in approved pharmaceutical manufacturing facilities

  • Avoid exposure without protective equipment

  • Prevent dust generation and inhalation

  • Follow GMP containment procedures

  • Dispose according to regulatory guidelines

Storage

  • Store in tightly closed containers

  • Protect from moisture and light

  • Maintain controlled room temperature

  • Keep in designated API storage areas

  • Follow GMP warehouse practices

FAQs

What is Fexofenadine Hydrochloride API used for?

Fexofenadine Hydrochloride API is used in pharmaceutical formulations for the treatment of allergic rhinitis and chronic urticaria.

Is Chemox Pharma a Fexofenadine Hydrochloride API manufacturer in India?

Yes, Chemox Pharma is a WHO-GMP certified Fexofenadine Hydrochloride API manufacturer and supplier in India serving global pharmaceutical companies.

What is the CAS number of Fexofenadine Hydrochloride?

The CAS number of Fexofenadine Hydrochloride API is 153439-40-8.

What is the therapeutic class of Fexofenadine Hydrochloride API?

Fexofenadine Hydrochloride belongs to the second-generation antihistamine (H1 receptor antagonist) class used in allergy treatment.

How should Fexofenadine Hydrochloride API be stored?

It should be stored in tightly closed containers at controlled room temperature, protected from moisture and light, following pharmaceutical storage guidelines.

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