Levocetirizine + Montelukast Tablet 2.5mg+4mg

Levocetirizine + Montelukast Tablet 2.5mg+4mg Technical Specification:

Product Name:	Levocetirizine + Montelukast Tablet IP
Brand Name:	Generics
Strength:	(2.5mg+4mg), (10mg+5mg)
Dosage Form:	Tablet (Enteric coated)
Route of Administration:	Via oral Route
Packing:	10s, 30s, 100s
Pack Insert/Leaflet:	PIL (Patient Information Leaflet)
Regulatory Documents:	COA, MOA, Stability Studies, GMP
Therapeutic use:	Antiallergic
Indication:	Combination therapy (montelukast plus levocetirizine) is a more effective strategy than monotherapy in the treatment of persistent allergic rhinitis.
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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Levocetirizine + Montelukast Tablet IP 10mg+5mg
  
• Levocetirizine + Montelukast Tablet IP 2.5mg+4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Levocetirizine + Montelukast Tablet IP 10mg+5mg
  Each film-coated tablet contains:
  Montelukast Sodium
  equivalent to Montelukast I.P.…………………………….10mg
  Levocetirizine Hydrochloride I.P……………………………5mg
  Excipients…………………………………. q.s.
  Colours: Sunset Yellow FCF
• b) Levocetirizine + Montelukast Tablet IP 2.5mg+4mg
  Each film-coated tablet contains:
  Montelukast Sodium
  equivalent to Montelukast…………………………….2.5mg
  Levocetirizine Hydrochloride……………………………5mg
  Excipients…………………………………. q.s.
  Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

• It’s usually prescribed when asthma is mild and can stop it from getting worse. It can also help people with asthma who have breathing difficulties when they exercise (exercise-induced asthma) and seasonal allergies, such as sneezing, itchiness and a blocked or runny nose (allergic rhinitis).

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 Levocetirizine + Montelukast Tablet 2.5mg+4mg

Levocetirizine + Montelukast Tablet 2.5mg+4mg is a proven combination therapy widely prescribed for managing allergic rhinitis, hay fever, asthma prevention, and skin hives.
This medicine combines:

• Levocetirizine – an antihistamine that blocks histamine effects, reducing sneezing, runny nose, and watery eyes.

• Montelukast – a leukotriene receptor antagonist that prevents airway inflammation and constriction, making it highly effective for asthma and allergy control.

Globally, demand for Levocetirizine + Montelukast Tablets is increasing due to rising allergic conditions, urban pollution, and seasonal changes. Healthcare systems in Asia, Africa, Latin America, and CIS countries are actively importing this combination therapy to improve patient outcomes.

Taj Pharma, a WHO-GMP certified manufacturer in India, leads in producing high-quality Levocetirizine + Montelukast Tablet 2.5mg+4mg for export, PCD franchise, and bulk supply worldwide.

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Details for Importers, Exporters, and Global Buyers

Taj Pharma ensures international buyers receive products that meet all regulatory, quality, and documentation standards. Here’s what makes our offering buyer-friendly:

Regulatory Documentation Provided

• WHO-GMP Certificate

• EU-GMP Compliance (where applicable)

• Certificate of Pharmaceutical Product (COPP)

• CTD/eCTD Dossier for registration

• Free Sale Certificate

• COA (Certificate of Analysis)

• Stability Data (Zone-wise ICH guidelines)

Custom Packaging & Labeling

• Available in Alu-Alu and Blister Packs

• Custom brand printing for private labeling

• Multilingual packaging for target markets

• Tamper-evident packaging for export safety

Shelf-life, Storage & Dosage Form

• Shelf-life: 24–36 months from manufacturing date

• Storage: Below 25°C, dry place, away from sunlight

• Dosage Form: Oral Tablets, Film-coated for stability

Export Certifications

• WHO-GMP

• EU-GMP (on demand)

• ISO 9001:2015

• HACCP

• US-FDA compliant manufacturing practices

Target Export Markets

Taj Pharma has a robust export network in:

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

• Asia: Philippines, Vietnam, Myanmar, Sri Lanka

• CIS: Ukraine, Uzbekistan, Kazakhstan

• Middle East: UAE, Saudi Arabia, Oman, Iraq

• Latin America: Peru, Chile, Guatemala

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Why Taj Pharma is the Most Trusted Manufacturer & Exporter

Taj Pharma is more than just a Levocetirizine + Montelukast Tablet manufacturer in India — it’s a global pharmaceutical partner.

1. State-of-the-Art Manufacturing

• WHO-GMP & ISO-certified facilities in Vapi, Gujarat

• Fully automated production lines

• Zero contamination assurance with closed-system manufacturing

2. Affordable Pricing with Uncompromised Quality

• Direct factory-to-buyer supply chain

• Competitive bulk order rates

• Flexible MOQs (Minimum Order Quantities) for new markets

3. Global Presence & Export Expertise

• Exports to 50+ countries

• Proven documentation support for fast product registrations

• Efficient international logistics & shipping partnerships

4. Top 20 Export Destinations

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

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Technical Product Specification

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PCD Pharma Franchise Opportunities

Taj Pharma also offers Levocetirizine + Montelukast Tablet PCD Pharma Franchise with:

• Monopoly rights for marketing in selected regions

• Promotional material support

• Competitive pricing for franchise partners

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Top 20 FAQs 

1. What is Levocetirizine + Montelukast Tablet 2.5mg+4mg used for?
It treats allergies, hay fever, asthma prevention, and skin hives.

2. How should it be taken?
Once daily, usually in the evening, as prescribed.

3. Can it be taken before exercise?
Yes, if exercise triggers asthma, take it 2 hours before.

4. Does it cause drowsiness?
Some patients may experience mild drowsiness.

5. Is it safe for long-term use?
Yes, under medical supervision.

6. Who manufactures it in India?
Taj Pharma is a leading WHO-GMP certified manufacturer.

7. Can it be exported from India?
Yes, Taj Pharma exports to over 50 countries.

8. Is private labeling available?
Yes, with custom branding and packaging.

9. What is the shelf life?
24–36 months from manufacturing.

10. Is it WHO-GMP certified?
Yes.

11. What is the MOQ for export orders?
Negotiable depending on buyer needs.

12. Can Taj Pharma provide CTD dossiers?
Yes.

13. Which countries import this product?
Africa, Asia, CIS, Middle East, Latin America.

14. Is it suitable for children?
Dosage should be as per pediatric guidance.

15. Are there side effects?
Possible mild headache, drowsiness, or stomach upset.

16. Is it available in Alu-Alu packing?
Yes.

17. Can Taj Pharma arrange shipping?
Yes, via air and sea freight.

18. Is price competitive for bulk buyers?
Yes, direct manufacturer pricing.

19. How to place an order?
Contact Taj Pharma’s export division.

20. Does Taj Pharma have export licenses?
Yes, fully licensed for global exports.