Fexofenadine Hydrochloride & Montelukast Tablets

Fexofenadine Hydrochloride & Montelukast Tablets 120mg+10mg Technical Specification:

Product Name:	Fexofenadine Hydrochloride & Montelukast Tablets 120mg+10mg
Brand Name:	MONTAJ-F
Strength:	10/20mg
Dosage Form:	Tablet
Route of Administration:	Via Oral Route
Packing:	10s, 30s, 100s, 500s
Pack Insert/Leaflet:	PIL (Patient Information Leaflet), smpc
Documents:	COA, MOA, Stability Studies, GMP
Therapeutic use:	Antihistamine
Indication:	treating allergic rhinitis (sneezing, runny nose, congestion) and allergic skin conditions like chronic urticaria.
Storage:	Store at a temperature not exceeding 30oC. Protect from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Fexofenadine Hydrochloride & Montelukast Tablets 120mg+10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Each film-coated bilayer tablet contains:
Montelukast Sodium IP
equivalent to Montelukast                       10mg
Fexofenadine Hydrochloride I.P            120mg
Excipients                                                q.s.
Colours: Yellow Oxide of Iron
(In Montelukast Layer)

THERAPEUTIC INDICATIONS:

relief of allergic rhinitis (seasonal/perennial hay fever) and associated symptoms. It works by combining an anti-allergic (fexofenadine) with a leukotriene inhibitor (montelukast) to treat sneezing, runny nose, nasal congestion, and watery eyes.

CAUTION & SCHEDULE:

CAUTION:  avoiding alcohol, waiting 2 hours after antacids, avoiding fruit juice, and using caution while driving.

SCHEDULE: SCHEDULE H:  Not to be sold by retail without the prescription of a Registered medical practitioner.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 30^oC. Protect from light and moisture.

Dosage: As prescribed by the Physician or refer enclosed pack insert.

Fexofenadine Hydrochloride & Montelukast Tablets Manufacturer in India

India has become a dominant force in the global pharmaceutical industry, offering high-quality medicines at competitive prices. Among the most widely prescribed anti-allergy combinations is Fexofenadine Hydrochloride & Montelukast Tablets, a highly effective treatment for allergic rhinitis and asthma-related symptoms.

Taj Pharma, based in Vapi, Gujarat, is a leading Fexofenadine Hydrochloride & Montelukast Tablets Manufacturer in India, known for delivering premium-quality formulations that meet international regulatory standards and global demand.

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 Introduction to Fexofenadine Hydrochloride & Montelukast Tablets

Fexofenadine Hydrochloride & Montelukast Tablets combine two powerful anti-allergic agents:

• Fexofenadine Hydrochloride – a non-sedating antihistamine
• Montelukast – a leukotriene receptor antagonist

This dual-action combination is widely used to treat:

• Allergic rhinitis (hay fever)
• Sneezing and runny nose
• Nasal congestion
• Watery eyes
• Asthma-related symptoms

Taj Pharma, the well-known Fexofenadine Hydrochloride & Montelukast Tablets manufacturer in India, ensures high-quality and purity in every batch, making it a trusted partner for global buyers.

Mechanism of Action

Montelukast works by blocking leukotrienes—chemical messengers responsible for inflammation in the airways and nasal passages. This reduces swelling and improves breathing.

Fexofenadine blocks histamine receptors, preventing allergic symptoms such as itching, sneezing, and watery eyes.

Together, they provide comprehensive relief from allergy symptoms.

Global Demand

With the rising prevalence of allergies and respiratory disorders worldwide, the demand for Fexofenadine Hydrochloride & Montelukast Tablets suppliers is growing rapidly. Countries in Asia, Africa, and Latin America depend on Indian exporters for affordable, high-quality formulations.

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 Medical Uses, Safety & Side Effects

Taj Pharma is a well-established Manufacturer, Exporter and Supplier of Fexofenadine Hydrochloride & Montelukast Tablets from Vapi, Gujarat India, offering reliable treatment solutions.

Indications

• Allergic rhinitis
• Sneezing and runny nose due to allergies
• Asthma symptom management
• Seasonal and perennial allergies

Common Side Effects

• Nausea
• Diarrhea
• Vomiting
• Skin rash
• Headache
• Drowsiness
• Dizziness
• Flu-like symptoms

Precautions

• Avoid driving or operating machinery due to possible dizziness or sleepiness
• Use under medical supervision
• Not recommended for self-medication

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H2: In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

Taj Pharma offers full regulatory support for international buyers:

• Certificate of Pharmaceutical Product (COPP)
• CTD/ACTD Dossier
• Certificate of Analysis (COA)
• Stability Data
• MSDS Documentation

Custom Packaging & Labeling

• Blister packs (PVC/Alu-Alu)
• Bottle packaging
• Private labeling options
• Multilingual labeling compliance

Shelf-Life, Storage & Dosage Form

• Dosage Form: Tablets
• Shelf Life: 24–36 months
• Storage: Store below 25°C, protect from moisture and light

Export Certifications

As a trusted WHO-GMP manufacturer in India, Taj Pharma provides:

• WHO-GMP Certification
• ISO Certifications
• EU-GMP compliance (if required)
• COPP for global registration

Target Countries & Export Markets

Taj Pharma exports Fexofenadine Hydrochloride & Montelukast Tablets to more than 50 countries, including:

• Africa: Nigeria, Kenya, South Africa
• Asia: Philippines, Vietnam, Myanmar
• Middle East: UAE, Saudi Arabia, Oman
• Latin America: Peru, Chile
• CIS Countries: Uzbekistan, Kazakhstan

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Why Taj Pharma is the Most Trusted Manufacturer & Exporter

State-of-the-Art Manufacturing

Taj Pharma operates advanced manufacturing facilities equipped with:

• Automated production lines
• Modern quality control laboratories
• Strict adherence to GMP standards

Affordable Pricing & Quality Assurance

As a leading Fexofenadine Hydrochloride & Montelukast Tablets supplier, Taj Pharma offers:

• Competitive pricing for bulk orders
• High-quality formulations
• Batch-to-batch consistency

Global Presence & Supply Chain Support

• Strong global distribution network
• Efficient logistics and export handling
• On-time delivery commitment

Top 20 Countries Exporting

India, USA, UK, Germany, France, Italy, Spain, UAE, Saudi Arabia, Nigeria, Kenya, South Africa, Vietnam, Philippines, Myanmar, Peru, Chile, Uzbekistan, Kazakhstan, Australia.

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 Technical Product Specification Table

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PAN India Manufacturer & Supplier Network

Taj Pharma is a leading:

• Fexofenadine Hydrochloride & Montelukast Tablets Manufacturer in Mumbai
• Manufacturer & Supplier in Vapi, Gujarat
• PAN India Supplier & Exporter
• PCD Pharma Franchise Provider

The company offers excellent distribution and franchise opportunities across India and global markets.

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 Call to Action for Buyers & Distributors

If you are looking for a reliable Fexofenadine Hydrochloride & Montelukast Tablets manufacturer in India, Taj Pharma is your trusted partner.

Why Choose Taj Pharma?

• WHO-GMP certified manufacturing
• Competitive pricing
• Global export expertise
• Reliable supply chain

📩 Contact Taj Pharma today to request:

• Product samples
• Pricing quotations
• Dossier documents
• Distribution partnerships

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Top 20 FAQs

1. What is this medicine used for?

It treats allergic rhinitis and asthma symptoms.

2. How does it work?

It blocks histamine and leukotrienes to reduce allergy symptoms.

3. Who is the best manufacturer in India?

Taj Pharma is a leading manufacturer and exporter.

4. What are common side effects?

Nausea, dizziness, headache, and drowsiness.

5. Can it cause sleepiness?

Yes, in some patients.

6. Is it safe for long-term use?

Yes, under medical supervision.

7. What certifications are provided?

WHO-GMP, COPP, CTD dossier.

8. Is private labeling available?

Yes.

9. What is the shelf life?

24–36 months.

10. How should it be stored?

Below 25°C.

11. Does it require a prescription?

Yes.

12. Can it be exported globally?

Yes.

13. What packaging options are available?

Blister packs and bottles.

14. Does Taj Pharma supply in bulk?

Yes.

15. Can it treat asthma?

Yes, it helps manage asthma symptoms.

16. What makes Taj Pharma unique?

Quality, affordability, and global reach.

17. Is it WHO-GMP certified?

Yes.

18. Does it interact with other medicines?

Consult a doctor before use.

19. How to contact Taj Pharma?

Via official website or export team.

20. Can it be used daily?

Yes, as prescribed by a doctor.