Theophylline Extended-Release Tablets 100mg

Theophylline Extended-Release Tablets 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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

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

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

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

F) Theophylline Extended-Release Tablets 600mg
Each Film-coated tablet contains:
Theophylline USP……………..……..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 & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.

Attach dispensing label as per end country.

Introduction: Overview of Theophylline Extended-Release Tablets 100mg and Global Demand

Theophylline Extended-Release Tablets 100mg are an essential treatment for chronic obstructive pulmonary disease (COPD) and asthma, offering sustained bronchodilation and improved airway function. These tablets are designed to release the active ingredient gradually, ensuring long-lasting symptom control and enhanced patient compliance.

Globally, the demand for Theophylline 100mg extended-release tablets is rising due to the increasing prevalence of respiratory disorders and the need for cost-effective, reliable bronchodilator therapy. Countries across Asia, Africa, the Middle East, and Latin America are sourcing high-quality Theophylline tablets from reputable Indian manufacturers.

Among these, Taj Pharma Ltd., Vapi, Gujarat, has emerged as a trusted manufacturer, exporter, and supplier, recognized for delivering premium-quality Theophylline Extended-Release Tablets 100mg with global regulatory compliance.

What are Theophylline Extended-Release Tablets 100mg?

Therapeutic Uses

• Maintenance treatment for asthma

• Prevention and management of COPD

• Relief of chronic bronchitis symptoms

• Long-term management of wheeze and shortness of breath

Mechanism of Action

Theophylline acts by inhibiting phosphodiesterase, increasing intracellular cAMP levels in bronchial smooth muscle. This relaxes airway muscles, dilates bronchial passages, and enhances airflow, improving breathing efficiency.

Dosage & Administration

• Typically taken once or twice daily, depending on physician instructions

• Preferably administered after meals

• Swallow whole tablets; do not crush or chew

• Not suitable for acute asthma attacks – keep a rescue inhaler handy

The Leading Theophylline Extended-Release Tablets 100mg Manufacturer in India

Taj Pharma Ltd., Vapi, Gujarat, is a pioneering Manufacturer, Exporter, and Supplier of Theophylline Extended-Release Tablets 100mg, known for high-quality, safe, and effective respiratory medicines.

1. Quality Assurance

Taj Pharma ensures:

• WHO-GMP-certified production

• Compliance with IP/BP/USP pharmacopoeial standards

• Multi-stage quality control testing

• Safe, pure, and effective formulations

2. State-of-the-Art Manufacturing

Facilities are equipped with:

• Modern production lines

• Advanced quality control laboratories

• Dedicated R&D departments

• Fully controlled manufacturing environments

3. Export-Oriented Production

• Supplies over 80 international markets

• Complete documentation for regulatory compliance

• Supports seamless import registration in target countries

Regulatory Support and Export Documentation

Taj Pharma provides full regulatory support for global buyers, ensuring hassle-free import and registration.

Key Documentation Provided

• WHO-GMP Certification

• Certificate of Pharmaceutical Product (COPP)

• CTD/ACTD Dossier

• Stability Data (Zone II & IVB)

• Free Sale Certificate

• Batch Manufacturing Records (BMR)

• Analytical Method Validation Reports

Custom Packaging & Labeling

• Multilingual labels for global distribution

• Private branding options

• 10×10 Alu-Alu / Blister packs

• Tamper-evident sealing with batch traceability

Product Details: 

PAN India Manufacturing & Supply

Taj Pharma supplies Theophylline Extended-Release Tablets 100mg across India, including key cities such as:

• Mumbai, Maharashtra

• Delhi NCR

• Bengaluru, Karnataka

• Hyderabad, Telangana

• Chennai, Tamil Nadu

• Ahmedabad, Gujarat

• Kolkata, West Bengal

Additionally, Taj Pharma offers PCD Pharma Franchise opportunities, providing:

• Monopoly rights for local distributors

• Marketing support and promotional tools

• Consistent product supply

Global Export Markets

Taj Pharma exports Theophylline Extended-Release Tablets 100mg to over 80 countries, with a reputation for quality, reliability, and timely delivery.

Top 20 Export Destinations

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

Why Taj Pharma is the Most Trusted Manufacturer & Exporter

1. WHO-GMP Certification

Ensures highest-quality manufacturing standards, safety, and consistency for all batches of Theophylline Extended-Release Tablets 100mg.

2. Competitive & Affordable Pricing

Taj Pharma combines premium quality with cost-effective pricing, making it accessible for global buyers.

3. Complete Regulatory & Documentation Support

Exporters and importers receive:

• CTD Dossiers

• COPP

• Free Sale Certificates

• Stability Reports

4. Robust Supply Chain

Advanced logistics ensure timely delivery, safe transport, and global availability.

5. Global Reputation

Trusted by hospitals, healthcare providers, and distributors for reliable, safe, and effective medicines.

Side Effects & Precautions

Common Side Effects:

• Nausea

• Vomiting

• Headache

• Insomnia

Precautions:

• Avoid caffeine and alcohol

• Monitor blood Theophylline levels as advised

• Not for acute asthma attacks

• Consult doctor for kidney, liver, or heart conditions

PCD Pharma Franchise Opportunities

Taj Pharma provides exclusive franchise opportunities for Theophylline Extended-Release Tablets 100mg:

• PAN India availability

• Monopoly rights

• Marketing and promotional support

• Continuous supply assurance

Call to Action for Buyers and Distributors

For high-quality Theophylline Extended-Release Tablets 100mg, Taj Pharma Ltd. is your trusted manufacturer, supplier, and exporter.

📞 Contact Taj Pharma Ltd.:
🌐 Website: www.tajpharma.com
📧 Email: info@tajpharma.com
🏭 Address: Plot No. 513, GIDC Estate, Vapi, Gujarat, India

Top 20 FAQs 

1. What is Theophylline Extended-Release Tablets 100mg used for?
   Asthma and COPD maintenance.

2. Who is the top manufacturer in India?
   Taj Pharma Ltd., Vapi, Gujarat.

3. How should it be administered?
   Once or twice daily, preferably after meals.

4. Common side effects?
   Mild nausea, vomiting, headache, insomnia.

5. Can it treat acute asthma attacks?
   No, use a rescue inhaler.

6. Shelf life?
   24–36 months.

7. Certifications of Taj Pharma?
   WHO-GMP, ISO 9001:2015, COPP, EU-GMP.

8. Export destinations?
   Over 80 countries including UAE, Kenya, and Vietnam.

9. Packaging type?
   10×10 Alu-Alu / Blister packs.

10. Is private labeling available?
    Yes, with multilingual labeling.

11. Long-term safety?
    Safe under physician supervision.

12. Taj Pharma location?
    Vapi, Gujarat, India.

13. Minimum order for export?
    Flexible according to market requirements.

14. Quality assurance measures?
    Multi-stage QC and WHO-GMP compliance.

15. Export documentation?
    CTD Dossier, COPP, Stability Data.

16. Franchise opportunities?
    Yes, PAN India.

17. Therapeutic class?
    Bronchodilator.

18. Other available strengths?
    200mg, 300mg, 400mg, 450mg, 600mg.

19. Are samples available?
    Yes, for evaluation.

20. Why choose Taj Pharma?
    Affordable, WHO-GMP certified, globally trusted.