Theophylline Prolonged-Release Tablets 400mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Theophylline Prolonged-Release Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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 400mg 

Theophylline Prolonged-Release Tablets 400mg are a widely prescribed bronchodilator medication used in the management and long-term control of chronic respiratory diseases such as:

• Asthma

• Chronic Bronchitis

• Chronic Obstructive Pulmonary Disease (COPD)

• Emphysema

Theophylline is known for relaxing airway smooth muscles, increasing airflow, and reducing bronchospasm. As a prolonged-release formulation, it maintains therapeutic blood levels for an extended duration, improving patient compliance and reducing dosing frequency.

Global demand for Theophylline Prolonged-Release Tablets 400mg continues to rise due to:

• Increasing COPD and asthma prevalence

• Growing need for cost-effective respiratory medicines

• Higher adoption in emerging markets

• Preference for long-acting bronchodilator therapies

India is a major hub for affordable and high-quality respiratory pharmaceuticals, and Taj Pharma stands out as the most trusted Theophylline Prolonged-Release Tablets 400mg manufacturer, supplier, and exporter.

Theophylline Prolonged-Release Tablets 400mg  

Taj Pharma, a well-known and WHO-GMP-certified Theophylline Prolonged-Release Tablets 400mg manufacturer in India, assures international buyers of:

• Strict quality compliance

• Purity and safety

• Regulatory-approved formulations

• Reliable global distribution

Taj Pharma’s Theophylline PR 400mg tablets are widely used for the treatment and prevention of COPD and asthma. As a bronchodilator, they relax the airway muscles, widen the airways, and make breathing easier.

Commonly observed side effects include:

• Nausea

• Vomiting

• Headache

• Insomnia

Taj Pharma ensures stringent quality checks to minimize adverse reactions and enhance therapeutic efficiency.

In-Depth Details for Importers, Exporters & Global Buyers

International buyers require complete regulatory documentation for product registration. Taj Pharma provides:

• WHO-GMP Certificate

• EU-GMP (upon request)

• Certificate of Pharmaceutical Product (COPP)

• Drug Master File (DMF) / CTD Dossier

• GMP Compliance Reports

• Stability Data (Zone III & IV)

• COA, MOA, Batch Manufacturing Records

• Free Sales Certificate

These documents enable seamless regulatory approval across global markets.

Custom Packaging & Private Labeling

Taj Pharma offers customized export packaging:

• Blister packs / Bottle packs

• Alu-Alu or PVC blister options

• Customized artwork with buyer’s branding

• Multilingual labeling as per importing country regulations

• Tamper-proof packaging

Ensuring safe shipment and long shelf-life during transportation.

Shelf-life, Storage & Dosage Form

Export Certifications

Taj Pharma delivers with internationally recognized certifications:

• WHO-GMP

• ISO 9001:2015

• GLP, GDP, GMP Compliance

• COPP Certification

• Regulatory Dossiers in CTD/ACTD Format

All these make Taj Pharma the preferred Theophylline Prolonged-Release Tablets 400mg exporter from India.

Target Countries & Export Markets

Taj Pharma exports Theophylline Prolonged-Release Tablets 400mg to:

• Middle East

• Africa

• Latin America

• CIS Countries

• Southeast Asia

• Europe (per regulatory approval)

• Caribbean Nations

Emerging markets require cost-effective respiratory medicines, making Taj Pharma the leading partner for sustainable supplies.

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

1. World-Class Manufacturing Infrastructure

Taj Pharma’s manufacturing facilities in Vapi, Gujarat operate under:

• WHO-GMP

• Schedule M compliance

• Automated production lines

• High-precision granulation & compression technology

• Modern analytical laboratories

This ensures consistent quality, purity, and potency of every batch.

2. Affordable Pricing & Global Quality Assurance

Taj Pharma offers competitive pricing without compromising on:

• API quality

• Good Manufacturing Practices

• International regulatory standards

This makes Taj Pharma the preferred Theophylline Prolonged-Release Tablets 400mg supplier in India for global government tenders, distributors, importers, and NGOs.

3. Strong Global Presence & Supply Chain

With a vast export footprint, Taj Pharma ensures:

• On-time shipments

• Secure packaging

• End-to-end logistical support

• Export documentation assistance

Buyers receive a hassle-free procurement experience.

Top 20 Countries  

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

Technical Product Specification  

Call to Action  

Are you looking for a reliable, WHO-GMP-certified, and cost-effective Theophylline Prolonged-Release Tablets 400mg manufacturer and exporter in India?

Taj Pharma is your trusted partner.

📩 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📞 Contact: +91 84484 44095 (Gen. Enq. 01)

Whether you are:

• A pharmaceutical distributor

• An international importer

• A government procurement agency

• A PCD pharma franchise partner

Taj Pharma ensures premium quality, competitive pricing, and worldwide supply support for your requirements.

Top 20 FAQs  

1. What are Theophylline Prolonged-Release Tablets 400mg used for?

They are used to treat asthma, COPD, bronchitis, and other chronic respiratory disorders.

2. Who is the best manufacturer of Theophylline PR 400mg in India?

Taj Pharma is widely recognized as the leading Theophylline Prolonged-Release Tablets 400mg manufacturer in India.

3. Are these tablets WHO-GMP certified?

Yes, Taj Pharma produces them under WHO-GMP compliance.

4. Are dossiers available for registration?

Yes, CTD/ACTD dossiers and COPP certificates are provided.

5. What is the shelf life?

24–36 months depending on packaging.

6. Can Taj Pharma support custom export packaging?

Yes, private labeling and multilingual packaging options are available.

7. Is Theophylline 400mg suitable for asthma patients?

Yes, it is commonly prescribed for asthma management.

8. Does Taj Pharma export worldwide?

Yes, Taj Pharma exports to 40+ countries.

9. What are the common side effects?

Headache, nausea, vomiting, and insomnia.

10. Can buyers request branded or unbranded versions?

Both options are available.

11. Is a prolonged-release formulation better?

Yes, it provides sustained therapeutic effect and better patient compliance.

12. What is the MOQ for export orders?

Typically 100,000 tablets.

13. Are free samples available?

Yes, samples can be provided upon request for regulatory purposes.

14. What packaging options do you provide?

Blister, alu-alu, and bottle packs.

15. What are Taj Pharma’s certifications?

WHO-GMP, ISO 9001:2015, GLP, GDP.

16. Do you offer third-party manufacturing?

Yes, under strict confidentiality.

17. What is the lead time for export shipments?

2–4 weeks depending on order size.

18. Does Taj Pharma comply with EU/US standards?

Products are manufactured under international GMP guidelines.

19. What markets commonly import this product?

Africa, Asia, Middle East, Latin America.

20. How do I place a bulk order?

Contact Taj Pharma via email or the official website.