Montelukast+Levocetirizine+Acebrophylline (SR) Tablet 10mg+5mg+200mg

Montelukast+Levocetirizine+Acebrophylline (SR) Tablet Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Montelukast+Levocetirizine+Acebrophylline (SR) Tablet 10mg+5mg+200mg
  

QUALITATIVE AND QUANTITATIVE COMPOSITION:

•  a) Montelukast+Levocetirizine+Acebrophylline (SR) Tablet 10mg+5mg+200mg
  Each uncoated bilayer tablet contains:
  Montelukast Sodium
  equivalent to Montelukast I.P.…………………………….10mg
  Levocetirizine Hydrochloride I.P……………………………5mg
  Acebrophylline……………………………………………….200mg
  (As Sustained release)
  Excipients…………………………………. q.s.
  Colours: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

• ACEBROPHYLLINE+MONTELUKAST is a respiratory medication, primarily used to treat and prevent respiratory disorders like asthma attacks, chronic obstructive pulmonary diseases (COPD) and allergic rhinitis (hay fever).

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 Montelukast+Levocetirizine+Acebrophylline (SR) Tablet 10mg+5mg+200mg

Montelukast+Levocetirizine+Acebrophylline (SR) Tablet 10mg+5mg+200mg is a highly effective combination used for the management of asthma, chronic obstructive pulmonary disease (COPD), and allergic conditions. This three-in-one formulation provides comprehensive relief by targeting multiple pathways:

• Montelukast: A leukotriene receptor antagonist that prevents airway inflammation.

• Levocetirizine: A second-generation antihistamine that relieves allergy symptoms like sneezing, runny nose, and watery eyes.

• Acebrophylline (SR): A mucolytic and bronchodilator that loosens mucus and relaxes airway muscles, improving breathing.

Globally, the demand for this medicine has surged due to the rising prevalence of asthma, bronchitis, COPD, and allergic rhinitis. With millions of patients affected worldwide, this formulation has become a go-to therapy for doctors.

Taj Pharma, headquartered in Vapi, Gujarat, India, is the top-ranked manufacturer, supplier, and exporter of this product. Our facility complies with WHO-GMP, EU-GMP, and ISO standards, ensuring unmatched quality for domestic and international buyers.

In-depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma provides complete documentation to ensure smooth registration and approvals in international markets:

• WHO-GMP Certificate

• EU-GMP / PIC/S approval (where required)

• COPP (Certificate of Pharmaceutical Product)

• CTD / ACTD Dossiers

• Free Sale Certificates

• COA (Certificate of Analysis)

• Stability data and analytical methods

Custom Packaging & Labeling

• Blister packs, alu-alu strips, and HDPE bottles available.

• Multilingual labeling compliant with local regulatory norms.

• Customized packaging design for distributors and franchise partners.

Shelf-life, Storage, Dosage Form

• Shelf-life: 24–36 months depending on storage conditions.

• Storage: Store in a cool, dry place below 30°C, away from moisture and sunlight.

• Dosage Form: Sustained Release (SR) tablet for controlled drug release and improved patient compliance.

Export Certifications

• WHO-GMP Certified Manufacturer India

• EU-GMP / PIC/S Approval

• ISO 9001:2015 Quality Certification

• COA Batch Release Certificates

Target Countries & Export Markets

Taj Pharma exports to more than 40 countries worldwide, including:

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

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

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

• CIS Countries: Kazakhstan, Uzbekistan, Ukraine, Belarus

• Latin America: Peru, Bolivia, Chile, Guatemala

Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing

• WHO-GMP & EU-GMP certified plant in Vapi, Gujarat.

• Modern QC & QA labs with stringent testing.

• Automated production lines for high-volume output.

Affordable Pricing & Quality Assurance

• Cost-efficient manufacturing ensures competitive pricing.

• Products undergo stringent in-process checks.

• Compliance with US Pharmacopeia, British Pharmacopeia, and IP standards.

Global Presence & Supply Chain Support

• Export network across Asia, Africa, CIS, LATAM, and the Middle East.

• Partnerships with distributors, government tenders, and hospitals.

• Efficient logistics and on-time global delivery.

Top 20 Export Countries

1. Nigeria

2. Kenya

3. South Africa

4. Vietnam

5. Philippines

6. UAE

7. Saudi Arabia

8. Iraq

9. Sri Lanka

10. Myanmar

11. Ethiopia

12. Ghana

13. Kazakhstan

14. Uzbekistan

15. Peru

16. Chile

17. Guatemala

18. Yemen

19. Afghanistan

20. Belarus

Technical Product Specification

Call to Action for Buyers and Distributors

If you are looking for a reliable Montelukast+Levocetirizine+Acebrophylline (SR) Tablet 10mg+5mg+200mg manufacturer in India, Taj Pharma is your ideal partner.

We offer:

• PCD Pharma Franchise Opportunities

• Bulk supply for tenders & hospitals

• Private labeling services for global distributors

📞 Contact Taj Pharma today to discuss partnership opportunities and get the best quotations for exports.

Top 20 FAQs 

1. What is Montelukast+Levocetirizine+Acebrophylline (SR) Tablet used for?
It is used to treat asthma, COPD, bronchitis, and allergic rhinitis by reducing inflammation, clearing mucus, and relieving allergy symptoms.

2. Who manufactures this combination in India?
Taj Pharma, Vapi, Gujarat is a leading WHO-GMP certified manufacturer and exporter.

3. What certifications does Taj Pharma provide for exports?
WHO-GMP, EU-GMP, COPP, COA, and complete CTD/ACTD dossier support.

4. What is the shelf life?
Typically 24–36 months depending on packaging.

5. Can this medicine be exported to Africa?
Yes, Taj Pharma exports extensively to Nigeria, Kenya, Ethiopia, Ghana, and South Africa.

6. Does Taj Pharma provide custom labeling?
Yes, multilingual labeling and packaging options are available.

7. What is the recommended dosage?
As prescribed by your doctor, usually once daily after food.

8. Can it be used for sudden asthma attacks?
No, it is not for immediate relief. Use a rescue inhaler instead.

9. What are common side effects?
Nausea, headache, skin rash, drowsiness, diarrhea, and flu-like symptoms.

10. Can children take this formulation?
Use only under pediatrician supervision.

11. Is Taj Pharma a WHO-GMP manufacturer in India?
Yes, Taj Pharma is a WHO-GMP and ISO-certified manufacturer.

12. Can I order in bulk from Taj Pharma?
Yes, bulk orders are accepted for exports and franchise supply.

13. Does Taj Pharma supply to government tenders?
Yes, Taj Pharma is an approved vendor in many global government procurement programs.

14. How is Acebrophylline (SR) helpful?
It thins mucus and relaxes airway muscles, improving breathing.

15. Can this tablet be taken with antacids?
Avoid taking antacids within 30 minutes of this medication.

16. Is this formulation available for private labeling?
Yes, Taj Pharma supports private branding for international partners.

17. What is Taj Pharma’s export reach?
Over 40 countries across 5 continents.

18. Can I get samples before bulk purchase?
Yes, samples are provided for quality assurance.

19. How can I get a quotation?
Reach out via Taj Pharma’s official website or export division team.

20. Why choose Taj Pharma over others?
Because of affordable pricing, high quality, regulatory support, and global trust.

Taj Pharma stands as the 1 Montelukast+Levocetirizine+Acebrophylline (SR) Tablet 10mg+5mg+200mg manufacturer in India, offering world-class formulations trusted across continents. With WHO-GMP certification, global distribution channels, and a reputation for affordable quality, Taj Pharma remains the most reliable partner for buyers, importers, and PCD pharma franchise companies worldwide.