Theophylline + Montelukast Capsule (400mg+10mg)

Theophylline + Montelukast Capsule (400mg+10mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Theophylline +Montelukast Capsule 400mg+10mg 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Theophylline +Montelukast Capsule 400mg+10mg
  Each Uncoated tablet contains:
  Montelukast Sodium
  equivalent to Montelukast I.P.…………10mg
  Theophylline ……………………………400mg
  Excipients…………………………………. q.s
  Colours: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

MONTELUKAST+THEOPHYLLINE belongs to the group of medicines known as ‘anti-allergic or anti-asthmatic‘ primarily used to treat symptoms of Asthma. </br>

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 Theophylline + Montelukast Capsule (400mg+10mg)

Theophylline + Montelukast Capsule (400mg+10mg) is a prescription medication widely used for the long-term management and prevention of asthma and Chronic Obstructive Pulmonary Disease (COPD). Unlike rescue inhalers, these capsules are not intended to relieve sudden breathing difficulties but are designed to maintain airway health, reduce inflammation, and prevent bronchospasm.

Montelukast works as a leukotriene receptor antagonist, preventing airway inflammation and narrowing, while Theophylline is a bronchodilator that relaxes airway muscles and improves airflow. This combination ensures enhanced symptom control and better quality of life for patients suffering from respiratory conditions.

Globally, the demand for combination therapy capsules like Theophylline + Montelukast (400mg+10mg) has been steadily increasing due to rising prevalence of asthma, COPD, and chronic respiratory disorders. Pharmaceutical importers and distributors prefer trusted Indian manufacturers for quality, cost-effectiveness, and export compliance.

In-Depth Details for Importers, Exporters, and Global Buyers

Taj Pharma offers comprehensive solutions for global buyers seeking Theophylline + Montelukast Capsule (400mg+10mg), including regulatory, packaging, and logistical support.

Regulatory Documentation Provided

Taj Pharma ensures smooth international trade by providing:

• Certificate of Analysis (COA)

• WHO-GMP & EU-GMP compliance certificates

• Export licenses and legal permits

• Drug Master Files and CTD Dossiers

Custom Packaging & Labeling

Taj Pharma offers customized packaging to meet regulatory and marketing requirements. Options include:

• Blister packs

• Bottles or cartons

• Custom labels and branding

Shelf-Life, Storage, Dosage Form

• Dosage form: Capsule

• Strength: Theophylline 400mg + Montelukast 10mg

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

• Storage: Store in a cool, dry place away from sunlight

Export Certifications

Taj Pharma is certified under WHO-GMP, EU-GMP, and COPP, ensuring global regulatory compliance and reliability for international buyers. All necessary CTD dossiers and supporting documentation are provided for import and distribution.

Target Countries & Export Markets

Taj Pharma exports Theophylline + Montelukast Capsule (400mg+10mg) to 20+ countries, including:
USA, UK, Germany, France, Canada, UAE, Saudi Arabia, Australia, South Africa, Kenya, Nigeria, Brazil, Singapore, Malaysia, Thailand, Vietnam, Philippines, Russia, Egypt, Bangladesh.

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

State-of-the-Art Manufacturing

Taj Pharma’s Vapi, Gujarat facility uses high-end machinery, automated production lines, and advanced quality control labs, ensuring each capsule meets international standards of safety, potency, and efficacy.

Affordable Pricing & Quality Assurance

Taj Pharma combines premium quality with competitive pricing, making it the ideal choice for pharmaceutical distributors, wholesalers, and PCD franchise partners globally.

Global Presence & Supply Chain Support

With a robust supply chain, Taj Pharma ensures timely delivery to all countries, providing cold-chain logistics, tracking support, and seamless shipment handling.

Top 20 Countries Exporting

India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile

Technical Product Specification Table

Call to Action for Buyers and Distributors

If you are a pharmaceutical importer, distributor, or PCD franchise partner, Taj Pharma is your trusted source for Theophylline + Montelukast Capsule (400mg+10mg). Contact Taj Pharma today to:

• Request bulk quotations and pricing

• Obtain regulatory documents for imports

• Explore customized packaging solutions

• Partner with a WHO-GMP-certified manufacturer

Reach out via Taj Pharma Contact Page to secure high-quality, internationally approved capsules for your market.

Top 20 FAQs

1. What is Theophylline + Montelukast used for?
   It is used for long-term prevention and management of asthma and COPD.

2. Is a prescription required?
   Yes, this is a prescription-only medication.

3. Can it treat sudden asthma attacks?
   No, it is not a rescue medicine. Use a rescue inhaler for sudden symptoms.

4. What is the recommended dosage?
   Follow your doctor’s prescription; usually once daily in the evening.

5. Can it be used for children?
   Pediatric use must be under a doctor’s guidance.

6. What are the common side effects?
   Nausea, vomiting, upset stomach, headache, restlessness, flu-like symptoms.

7. How should it be taken?
   Take at the same time each day, preferably after food.

8. Can I stop taking it if I feel better?
   No, consult your doctor before stopping.

9. Does smoking affect the medication?
   Smoking may alter the dose needed; consult your physician.

10. What storage conditions are required?
    Store in a cool, dry place away from direct sunlight.

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

12. Can it cause dizziness or restlessness?
    Some patients may experience mild dizziness or restlessness.

13. Does it interact with other medications?
    Yes, always inform your doctor of all medications being taken.

14. Can it be used during pregnancy?
    Only under medical supervision.

15. Is it WHO-GMP certified?
    Yes, Taj Pharma provides WHO-GMP, EU-GMP, and COPP certifications.

16. Can I buy in bulk for export?
    Yes, Taj Pharma supplies international buyers.

17. Are there any dietary restrictions?
    No specific restrictions, but take as advised by your physician.

18. Can it be used alongside rescue inhalers?
    Yes, rescue inhalers are for sudden symptoms.

19. How do I get regulatory documents for import?
    Taj Pharma provides all necessary export documentation.

20. Why choose Taj Pharma?
    Trusted WHO-GMP-certified manufacturer, quality assurance, affordable pricing, and reliable global supply chain.