GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Theophylline Prolonged-Release Tablets 100mg
B. Theophylline Prolonged-Release Tablets 200mg
C. Theophylline Prolonged-Release Tablets 300mg
D. Theophylline Prolonged-Release Tablets 400mg
E. Theophylline Prolonged-Release Tablets 450mg
F. Theophylline Prolonged-Release Tablets 600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Theophylline Prolonged-Release Tablets 100mg
Each Film-coated tablet contains:
Theophylline IP……………..……..100mg
Excipients……………………………q.s
Colour: Sunset yellow lake

B. Theophylline Prolonged-Release Tablets 200mg
Each Film-coated tablet contains:
Theophylline IP……………..……..200mg
Excipients……………………………q.s
Colour: Sunset yellow

C. Theophylline Prolonged-Release Tablets 300mg
Each Film-coated tablet contains:
Theophylline IP……………..……..300mg
Excipients……………………………q.s
Colour: Sunset yellow FCF

D. Theophylline Prolonged-Release Tablets 400mg
Each Film-coated tablet contains:
Theophylline IP……………..……..400mg
Excipients……………………………q.s
Colour: Tartrazine yellow

E. Theophylline Prolonged-Release Tablets 450mg
Each Film-coated tablet contains:
Theophylline IP……………..……..450mg
Excipients……………………………q.s
Colour: Red oxide of iron


F. Theophylline Prolonged-Release Tablets 600mg
Each Film-coated tablet contains:
Theophylline IP……………..……..600mg
Excipients……………………………q.s
Colour: Resorcin brown

THERAPEUTIC INDICATIONS:

Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.

CAUTION & SCHEDULE:

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.
Dispense in tight container.
Protect from light and moisture.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Theophylline Prolonged-Release Tablets 450mg Technical Specification:

Product Name: Theophylline Prolonged-Release Tablets
Brand Name: Generic
Strength: (100mg), (200mg), (300mg), (400mg), (450mg), (600mg)
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Anti-Asthmatic
Indication: Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
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. Dispense in tight container. Protect from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Theophylline Prolonged-Release Tablets 450mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Theophylline Prolonged-Release Tablets 450mg
    Each Film-coated tablet contains:
    Theophylline IP……………..……..450mg
    Excipients……………………………q.s
    Colour: Red oxide of iron

THERAPEUTIC INDICATIONS:

Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. 

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. Dispense in tight container.
Protect from light and moisture.
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Introduction to Theophylline Prolonged-Release Tablets 450mg

Theophylline Prolonged-Release Tablets 450mg are a prescription bronchodilator used widely across the world in the treatment of respiratory disorders such as:

  • Chronic Asthma

  • Chronic Bronchitis

  • Chronic Obstructive Pulmonary Disease (COPD)

  • Emphysema

As a long-acting bronchodilator, Theophylline works by:

  • Relaxing the smooth muscles of the airways

  • Improving airflow

  • Reducing inflammation

  • Making breathing easier for patients with chronic lung disease

These extended-release tablets maintain stable therapeutic levels, making them ideal for long-term management of breathing disorders.

With the increasing global burden of COPD and asthma—especially in Africa, Asia, and Latin America—the demand for high-quality Theophylline Prolonged-Release Tablets 450mg continues to rise among:

  • Pharmaceutical distributors

  • Hospital procurement units

  • Government health programs

  • Importers and tender suppliers

  • PCD franchise companies

This growing demand has positioned Taj Pharma as the leading, most reliable, and globally recognized Theophylline Prolonged-Release Tablets 450mg Manufacturer in India.


 The Most Recognized Theophylline Prolonged-Release Tablets 450mg Manufacturer in India

Taj Pharma is a well-known and highly trusted Theophylline Prolonged-Release Tablets 450mg Manufacturer Supplier and Exporter from Vapi, Gujarat, India, offering unmatched quality, regulatory compliance, and global supply capabilities.

Why Taj Pharma is Trusted Worldwide?

  • WHO-GMP certified state-of-the-art facilities

  • Highly standardized production processes

  • Use of premium-grade APIs

  • Affordable pricing with global quality

  • Timely deliveries across 40+ countries

  • 20+ years of pharmaceutical expertise

Taj Pharma ensures every batch of Theophylline Prolonged-Release Tablets 450mg is:

  • Pure

  • Safe

  • Potent

  • Compliant with international standards

Patients benefit from:

  • Improved breathing

  • Reduced inflammation

  • Better airflow

  • Fewer asthma or COPD flare-ups

Common tolerable side effects include nausea, vomiting, headache, and occasional insomnia.


 In-Depth Importer/Exporter Information for Theophylline PR 450mg

Global buyers and pharmaceutical importers prefer Taj Pharma for its complete regulatory support, high reliability, and industry-leading quality standards.

 Regulatory Documentation Provided

Taj Pharma supplies full regulatory dossiers needed for product registration:

  • WHO-GMP Certificate

  • COPP (Certificate of Pharmaceutical Product)

  • FSC (Free Sale Certificate)

  • CTD / ACTD Dossier

  • Stability Data (Zone II, III, IV)

  • COA / MOA / Batch Manufacturing Records

  • DMF Support (if required)

  • Label & Packaging Proofs

  • Leaflet/Insert Design

This ensures easy approval in international markets.


 Custom Packaging & Private Labeling

Taj Pharma offers flexible packaging solutions for Theophylline Prolonged-Release Tablets 450mg, including:

  • Custom branding for distributors

  • Export-quality blister packs

  • Alu-Alu or PVC blister

  • HDPE bottles

  • Multilingual packaging

  • PCD Franchise packaging

Ideal for:

  • Exporters

  • Wholesalers

  • Distributors

  • Hospital supply chains


 Shelf-Life, Storage & Dosage Form

Parameter Details
Dosage Form Prolonged-Release Tablet
Strength 450mg
Pack Options 10×10 blister / bottle
Shelf-Life 24–36 months
Storage Store below 25°C; protect from moisture
Route of Administration Oral

  Export Certifications Available

Taj Pharma delivers export-grade Theophylline Prolonged-Release Tablets 450mg with:

  • WHO-GMP Certification

  • ISO 9001:2015

  • COPP

  • FSC

  • GLP Compliance

  • GMP Schedule M Certification

All required export documents are provided for registration and market entry.


 Target Global Markets

Taj Pharma exports this product to:

Africa:
Kenya, Tanzania, Uganda, Nigeria, Ethiopia, Ghana, Rwanda

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

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

Latin America:
Peru, Chile, Ecuador, Guatemala

CIS Countries:
Kazakhstan, Uzbekistan, Georgia


 Why Taj Pharma is the Most Trusted Global Manufacturer & Exporter

Taj Pharma stands out as the Leading #1 Theophylline Prolonged-Release Tablets 450mg Manufacturer & Supplier in India because of the following strengths:


  World-Class WHO-GMP Manufacturing

Taj Pharma’s plant in Vapi features:

  • Modern tablet compression systems

  • HVAC-controlled clean rooms

  • Automatic blister packing

  • 100% in-process quality checks

  • Microbiology and analytical laboratories

All production is done under strict QA/QC standards.


 Competitive Pricing & High Purity Standards

Taj Pharma offers the best price in Mumbai, Maharashtra, and PAN India while maintaining:

  • Superior raw material quality

  • High API potency

  • Optimal dissolution profile

  • Batch consistency

A perfect balance of affordability and international-grade quality.


 Strong Global Presence

Taj Pharma exports to over 42+ countries, making them one of the largest bronchodilator suppliers globally.

They offer:

  • Temperature-controlled shipping

  • Fast logistics

  • Port-to-port delivery

  • Export documentation support


 Top 20 Exporting Countries

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

Technical Specification Table

Parameter Specification
Product Name Theophylline Prolonged-Release Tablets
Strength 450mg
Manufacturer Taj Pharma India
Therapeutic Class Bronchodilator
Indications COPD, Asthma, Chronic Bronchitis
Dosage Form Extended-Release Tablet
Packaging 10×10 Alu-Alu / Blister
Shelf Life 24–36 months
Certifications WHO-GMP, COPP, FSC
MOQ (Export) 100,000 tablets
Branding Private Label Available

 PCD Pharma Franchise for Theophylline PR 450mg

Taj Pharma provides PCD Pharma Franchise opportunities across:

  • Mumbai

  • Gujarat

  • Maharashtra

  • Karnataka

  • Delhi

  • Haryana

  • PAN India

Franchise partners receive:

  • Exclusive monopoly rights

  • Promotional material support

  • High-profit margins

  • Fast dispatch


 Top 20 FAQs 

1. What is Theophylline Prolonged-Release Tablets 450mg used for?

It treats asthma, COPD, chronic bronchitis, and emphysema.

2. What is its mechanism of action?

It relaxes airway muscles and improves airflow.

3. Is Taj Pharma WHO-GMP certified?

Yes, Taj Pharma is a certified WHO-GMP manufacturer.

4. What is the shelf life?

Typically 24–36 months.

5. Is it suitable for export?

Yes, Taj Pharma exports to 40+ countries.

6. Do you provide dossiers?

Yes, CTD and ACTD dossiers are available.

7. Can packaging be customized?

Yes, private labeling and custom branding are supported.

8. Are samples provided?

Samples are available for regulatory approval.

9. What are common side effects?

Headache, nausea, vomiting, insomnia.

10. Does the product have FDA approval?

This depends on the target country.

11. Can buyers order in bulk?

Yes, bulk and container loads are shipped worldwide.

12. Is stability data available?

Yes, Zone II–IV stability data is supplied.

13. What is the MOQ?

Minimum order quantity is 100,000 tablets.

14. Can Taj Pharma support product registration?

Yes, full documentation is provided.

15. Where is the product manufactured?

At Taj Pharma’s WHO-GMP plant in Vapi, Gujarat.

16. Does Taj Pharma offer PCD franchise rights?

Yes, PAN India franchise opportunities.

17. Is the product affordable?

Yes, it is priced competitively for global buyers.

18. Which countries import this formulation?

Africa, Middle East, CIS, Southeast Asia, Latin America.

19. How can buyers contact Taj Pharma?

Through the official website: www.tajpharma.com

20. Why choose Taj Pharma?

Superior quality, global trust, WHO-GMP manufacturing, affordable pricing.


 Call to Action 

For global buyers, importers, distributors, and PCD franchise seekers looking for a reliable Theophylline Prolonged-Release Tablets 450mg Manufacturer Supplier in India, Taj Pharma is the ideal partner.

📞 Contact Taj Pharma for:

  • Price quotations

  • Samples

  • CTD dossiers

  • Export support

  • Long-term supply partnerships

Visit: www.tajpharma.com
Email: info@tajpharma.com