Fexofenadine Hydrochloride+Montelukast Tablet 120mg+10mg

Fexofenadine Hydrochloride+Montelukast Tablet Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Fexofenadine Hydrochloride+Montelukast Tablet 120mg+10mg
  

QUALITATIVE AND QUANTITATIVE COMPOSITION:

•  a) Fexofenadine Hydrochloride+Montelukast Tablet 120mg+10mg
  Each film-coated tablet contains:
  Montelukast Sodium IP
  equivalent to Montelukast.…………………………….10mg
  Fexofenadine Hydrochloride I.P……………………………120mg
  Excipients…………………………………. q.s.
  Colours: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

• Montelukast+Fexofenadine is used in the treatment of sneezing and runny nose due to allergies. Montelukast is a leukotriene antagonist. It works by blocking the action of a chemical messenger called leukotriene. This reduces inflammation (swelling) in the airways and nose and improves symptoms.

CAUTION & WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
  
• SCHEDULE “H” Prescription Drug-Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
  

STORAGE & DOSAGE:

• Storage:Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
• Dosage: As directed by the Physician.

Introduction to Fexofenadine Hydrochloride+Montelukast Tablet 120mg+10mg

Fexofenadine Hydrochloride+Montelukast Tablet 120mg+10mg is a widely prescribed anti-allergic combination medicine that helps relieve symptoms of allergic rhinitis, hay fever, asthma-related allergies, and chronic urticaria (hives).

• Montelukast (10mg) is a leukotriene receptor antagonist that blocks the action of leukotrienes, chemical messengers responsible for inflammation, swelling, and mucus production in the airways. By reducing airway swelling, Montelukast improves breathing.

• Fexofenadine (120mg) is a non-sedating antihistamine that blocks histamine receptors, relieving sneezing, runny nose, watery eyes, and itching.

This dual-action formula makes the medicine highly effective in treating both respiratory and skin-related allergy symptoms.

Growing Global Demand

With the rising prevalence of allergic conditions, Montelukast + Fexofenadine combination has become a first-line therapy worldwide. According to the World Allergy Organization (WAO), over 30% of the global population suffers from allergic rhinitis and asthma, driving strong demand for these tablets in domestic and export markets.

Hence, reliable Fexofenadine Hydrochloride+Montelukast Tablet 120mg+10mg manufacturers in India like Taj Pharma play a crucial role in supplying high-quality medicines across international borders.

Regulatory, Packaging & Export Details for Buyers

International buyers, importers, and distributors require pharmaceutical partners who can ensure regulatory compliance, proper packaging, and quality documentation. Taj Pharma offers complete support.

✅ Regulatory Documentation Provided

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP, EU-GMP, ISO certifications

• Drug Master File (DMF) / Common Technical Document (CTD Dossier)

• Stability data (real-time & accelerated)

• Free Sale Certificate

• Manufacturing License & Batch Release Certificate

✅ Packaging & Labeling Options

• Blister packs (alu-alu, PVC)

• Strip packs or bottles

• Customized export-friendly labeling with multilingual inserts

• Tamper-proof, moisture-resistant packaging for long shelf-life

✅ Shelf-Life, Storage & Dosage Form

• Shelf life: 24–36 months

• Storage: Store below 25°C, away from heat and moisture

• Dosage Form: Film-coated oral tablets (120mg + 10mg)

✅ Export Certifications

• WHO-GMP Certified Manufacturer in India

• EU-GMP compliance for international markets

• ISO 9001:2015, ISO 14001:2015 certified facilities

• PIC/S standards and validated bioequivalence studies

✅ Export Markets and Target Countries

Taj Pharma exports Montelukast + Fexofenadine Tablets to regulated and semi-regulated markets, including:

• Asia: Vietnam, Sri Lanka, Nepal, Philippines, Myanmar

• Africa: Nigeria, Kenya, Ghana, South Africa, Ethiopia

• Middle East: UAE, Saudi Arabia, Oman, Kuwait, Qatar

• CIS & Europe: Russia, Kazakhstan, Ukraine, Poland

• Latin America: Brazil, Peru, Chile, Mexico

Why Taj Pharma is the Most Trusted Manufacturer & Exporter

Taj Pharma is among the top WHO-GMP certified Fexofenadine Hydrochloride+Montelukast Tablet 120mg+10mg manufacturers in India, known for its global reach and affordable quality.

1. State-of-the-Art Manufacturing

• Located in Vapi, Gujarat, with corporate presence in Mumbai

• WHO-GMP & EU-GMP certified advanced facilities

• Modern QC & QA labs for consistent quality

2. Affordable Pricing & Quality Assurance

• Competitive bulk order pricing

• Compliance with Indian Pharmacopeia (IP), BP, USP standards

• Each batch undergoes rigorous in-house testing

3. Global Presence & Supply Chain Support

• Active in 20+ countries worldwide

• Assistance with registration & dossier filing

• Reliable sea & air freight logistics

4. Top 20 Export Countries

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specification:

Looking for a reliable Fexofenadine Hydrochloride+Montelukast Tablet 120mg+10mg manufacturer in India?

Taj Pharma is your trusted global partner, offering quality-certified production, affordable pricing, and full regulatory support for international buyers, importers, and distributors.

📞 Contact Taj Pharma Ltd, Mumbai, India today to discuss bulk supply, export orders, or PCD Pharma Franchise opportunities.

Top 20 FAQs

1. What is Fexofenadine Hydrochloride+Montelukast Tablet used for?
It is used for treating allergic rhinitis, hay fever, hives, and asthma-related allergy symptoms.

2. Who manufactures Montelukast + Fexofenadine in India?
Taj Pharma Ltd is a leading WHO-GMP certified manufacturer.

3. How does Montelukast work?
It blocks leukotrienes, reducing airway swelling and mucus buildup.

4. How does Fexofenadine work?
It blocks histamine receptors, reducing sneezing, watery eyes, and runny nose.

5. Can I take this medicine with food?
Yes, it can be taken with or without food.

6. What are the common side effects?
Headache, drowsiness, dizziness, nausea, diarrhea, flu-like symptoms.

7. Should alcohol be avoided while taking it?
Yes, avoid alcohol as it increases drowsiness.

8. Can this medicine be taken during pregnancy?
Consult your doctor before use.

9. Can I drive after taking Montelukast + Fexofenadine?
It may cause dizziness, so caution is advised.

10. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, COPP, ISO certifications.

11. What is the shelf life of the tablets?
24–36 months depending on storage.

12. Does Taj Pharma support custom labeling?
Yes, multilingual and export-custom packaging is available.

13. Is this medicine sedating?
Fexofenadine is a non-sedating antihistamine, but mild drowsiness may occur in some patients.

14. Can I stop taking the tablets if symptoms improve?
Take as prescribed; consult your doctor before stopping.

15. Does Taj Pharma provide export dossiers?
Yes, CTD dossiers and stability data are available.

16. What is the recommended dosage?
Usually one tablet daily, but follow doctor’s advice.

17. Is it available under PCD Pharma Franchise?
Yes, Taj Pharma offers franchise opportunities across India.

18. Can the medicine affect allergy tests?
Yes, stop taking it at least 3 days before an allergy test.

19. Does Taj Pharma export to Africa & Latin America?
Yes, Taj Pharma exports to multiple markets across both regions.

20. How can I place a bulk order?
Contact Taj Pharma Export Division, Mumbai for quotations.