Theophylline Extended-Release Tablets 400mg

Theophylline Extended-Release Tablets 400mg 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: Understanding Theophylline Extended-Release Tablets 400mg and Global Demand

Theophylline Extended-Release Tablets 400mg are widely used in the treatment and prevention of asthma and chronic obstructive pulmonary disease (COPD). As a bronchodilator, Theophylline works by relaxing the muscles in the airways, thereby easing breathing and improving airflow to the lungs.

COPD and asthma are among the most prevalent respiratory disorders globally, affecting millions of individuals. The demand for effective, affordable, and WHO-GMP-certified Theophylline Extended-Release Tablets 400mg continues to rise, especially in developing and middle-income countries where respiratory disorders are common due to pollution and lifestyle factors.

Among the many pharmaceutical manufacturers in India, Taj Pharma Ltd. stands out as the most trusted Theophylline Extended-Release Tablets 400mg manufacturer, supplier, and exporter, recognized for its consistent quality, regulatory compliance, and customer-centric approach.

About Theophylline Extended-Release Tablets 400mg

Theophylline Extended-Release Tablets 400mg are a sustained-release formulation that provides prolonged therapeutic effects, ensuring a steady concentration of the drug in the bloodstream. This helps patients manage respiratory conditions effectively with fewer doses per day.

Key Therapeutic Uses:

• Asthma control and prevention

• Chronic obstructive pulmonary disease (COPD)

• Chronic bronchitis and emphysema

• Long-term respiratory maintenance therapy

Mechanism of Action:

Theophylline inhibits phosphodiesterase enzymes, increasing intracellular cyclic AMP levels, which relaxes smooth muscles in the bronchi and pulmonary blood vessels. It also enhances diaphragm contractility, improving breathing efficiency.

Dosage and Administration:

It is recommended to take Theophylline Extended-Release Tablets 400mg at the same time daily, preferably after food. The tablet must not be crushed or chewed to maintain the extended-release effect.

Why Taj Pharma is the Leading Theophylline Extended-Release Tablets 400mg Manufacturer in India

Taj Pharma Ltd., Vapi, Gujarat, India, is a globally recognized WHO-GMP, ISO, and EU-GMP-compliant manufacturer specializing in Theophylline Extended-Release Tablets 400mg. With decades of experience in formulation development and export, Taj Pharma ensures high-quality, affordable, and globally accepted pharmaceutical solutions.

1. Advanced Manufacturing Infrastructure

Taj Pharma’s manufacturing facilities in Vapi, Gujarat, are equipped with automated production lines, air-controlled environments, and precision equipment, ensuring quality consistency and adherence to Good Manufacturing Practices (GMP).

2. Global Quality Certifications

Taj Pharma holds international accreditations including:

• WHO-GMP Certification

• ISO 9001:2015

• COPP (Certificate of Pharmaceutical Product)

• CTD Dossier availability

• EU-GMP Compliance

• Regulatory documentation for export

3. Strong R&D and Quality Control

Taj Pharma’s in-house R&D division develops stable and bioequivalent formulations. The Quality Control Department performs tests for assay, dissolution, impurity profiling, and stability, ensuring each batch meets pharmacopoeial standards (IP/BP/USP).

4. Trusted Global Supplier

Taj Pharma exports Theophylline Extended-Release Tablets 400mg to over 80 countries worldwide, serving pharmaceutical importers, government tenders, hospitals, and PCD franchise partners.

 Product Highlights

• Product Name: Theophylline Extended-Release Tablets 400mg

• Therapeutic Class: Bronchodilator

• Form: Extended-release oral tablets

• Active Ingredient: Theophylline

• Manufacturer: Taj Pharma Ltd., Vapi, Gujarat, India

• Indications: Asthma, COPD, chronic bronchitis

• Packaging: 10×10 tablets in Alu-Alu or Blister packs

• Storage: Store below 30°C, in a cool and dry place

• Shelf Life: 24–36 months

• Certifications: WHO-GMP, ISO, COPP, EU-GMP

• Dosage: As prescribed by a healthcare provider

Regulatory Support and Export Documentation

For international buyers and importers, Taj Pharma provides complete regulatory and technical documentation to facilitate smooth import and product registration.

Available Export Documents:

• WHO-GMP Certificate

• COPP (Certificate of Pharmaceutical Product)

• Free Sale Certificate

• CTD/ACTD Dossier

• Stability Data (Zone II/IVB)

• Product Artwork and Label Designs

• Analytical Method Validation Reports

• Batch Manufacturing Records (BMR)

Custom Packaging & Labeling Options

Taj Pharma offers customized private labeling, multilingual packaging, and brand-specific designs, ensuring compliance with country-specific regulatory norms.

Manufacturer and Supplier PAN India

Taj Pharma is one of the few companies that offer PAN India supply and PCD Pharma Franchise opportunities for Theophylline products. Distributors, wholesalers, and franchise partners can rely on Taj Pharma for timely supply, competitive pricing, and promotional support.

Presence in Key Indian Cities:

• Mumbai, Maharashtra

• Ahmedabad, Gujarat

• Delhi NCR

• Hyderabad, Telangana

• Chennai, Tamil Nadu

• Kolkata, West Bengal

• Bengaluru, Karnataka

Global Export Markets

Taj Pharma’s commitment to regulatory excellence and product integrity has earned it a trusted name among international clients.

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 Global Importers Choose Taj Pharma

1. Uncompromised Quality Assurance

Each batch of Theophylline Extended-Release Tablets 400mg is manufactured under stringent quality systems, ensuring safety, efficacy, and compliance with international standards.

2. Competitive Pricing

Taj Pharma offers affordable pricing due to its economies of scale and efficient manufacturing processes, making it the preferred supplier for cost-sensitive markets.

3. Regulatory and Documentation Expertise

With in-depth experience in dossier preparation and export registration, Taj Pharma simplifies international trade processes for global clients.

4. Proven Track Record

Taj Pharma’s long-standing export partnerships and inclusion in global procurement programs make it one of the most reliable pharmaceutical exporters in India.

5. Excellent Supply Chain Support

Taj Pharma provides timely dispatches, flexible MOQs (Minimum Order Quantities), and logistics support for air and sea shipments.

Technical Product Specification Table

Dosage, Side Effects, and Precautions

Dosage:

Take Theophylline Extended-Release Tablets 400mg once or twice daily as prescribed. It should be taken after meals to minimize gastric irritation.

Side Effects:

Common side effects include:

• Nausea

• Vomiting

• Headache

• Insomnia (difficulty sleeping)
  Most effects are mild and transient. Consult your physician if symptoms persist.

Precautions:

• Avoid alcohol consumption.

• Monitor Theophylline blood levels during long-term therapy.

• Use with caution in patients with liver, kidney, or heart conditions.

• Not for immediate relief—keep a rescue inhaler handy.

Theophylline Extended-Release Tablets 400mg – PCD Pharma Franchise

Taj Pharma offers PCD Pharma Franchise opportunities for Theophylline Extended-Release Tablets 400mg across India. Partners receive:

• Marketing support materials

• Monopoly distribution rights

• WHO-GMP-quality medicines

• Attractive profit margins

This makes Taj Pharma the best business partner for those entering or expanding their respiratory medicine portfolio.

Call to Action  

Looking for a reliable Theophylline Extended-Release Tablets 400mg manufacturer and supplier in India?
Partner with Taj Pharma, your trusted source for high-quality, affordable pharmaceutical products.

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

Taj Pharma welcomes global importers, government procurement agencies, and distributors to collaborate for long-term supply partnerships.

Top 20 FAQs  

1. What is Theophylline Extended-Release Tablets 400mg used for?
Used to treat and prevent asthma and COPD, improving breathing.

2. Who is the leading manufacturer in India?
Taj Pharma Ltd., Vapi, Gujarat, is the top WHO-GMP-certified manufacturer.

3. How does Theophylline work?
It relaxes airway muscles and widens bronchi for easier breathing.

4. Is it safe for long-term use?
Yes, under medical supervision with regular blood level monitoring.

5. Can it be used for acute asthma attacks?
No, it’s not a rescue medicine; use a fast-acting inhaler instead.

6. What are the available pack sizes?
Standard 10×10 tablets; custom packaging available for export.

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

8. What certifications does Taj Pharma hold?
WHO-GMP, ISO 9001:2015, COPP, CTD Dossier, EU-GMP compliance.

9. Where is it manufactured?
At Taj Pharma’s state-of-the-art facility in Vapi, Gujarat, India.

10. Does Taj Pharma export globally?
Yes, to over 80 countries across Asia, Africa, and Latin America.

11. Can importers get custom labels?
Yes, multilingual and region-compliant packaging available.

12. What are common side effects?
Nausea, headache, and mild insomnia.

13. How should it be stored?
In a cool, dry place, away from light and moisture.

14. Is Taj Pharma a WHO-GMP manufacturer?
Yes, fully certified under WHO-GMP and ISO 9001:2015.

15. Can I order samples?
Yes, samples available upon request for regulatory registration.

16. What dosage strengths are available?
Available in 300mg, 400mg, 450mg, and 600mg variants.

17. Does Taj Pharma provide dossier support?
Yes, complete CTD/ACTD dossiers and technical files are available.

18. What countries import Theophylline from India?
Nigeria, Kenya, Philippines, Vietnam, UAE, and more.

19. How is quality ensured?
Through multi-stage in-process checks and analytical testing.

20. Why choose Taj Pharma?
For reliability, compliance, affordability, and global credibility.