Theophylline Prolonged-Release Tablets 200mg

Theophylline Prolonged-Release Tablets 200mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Theophylline Prolonged-Release Tablets 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

Theophylline Prolonged-Release Tablets 200mg is a long-acting bronchodilator medication used to prevent and manage symptoms of chronic lung diseases. It belongs to the methylxanthine class and works by relaxing airway muscles, reducing inflammation, and improving airflow to the lungs.

Key Uses:

• Treatment and prevention of Asthma

• Chronic Obstructive Pulmonary Disease (COPD)

• Chronic bronchitis

• Emphysema

• Restores normal breathing and reduces flare-ups

The prolonged-release mechanism ensures steady therapeutic levels in the bloodstream, creating a more controlled, sustained action with fewer doses.

Growing Global Demand

Demand for Theophylline Prolonged-Release Tablets 200mg continues to rise due to:

• Increasing prevalence of COPD worldwide

• Cost-effective bronchodilator alternatives

• Use in low-resource healthcare settings

• High demand in Africa, Latin America, Middle East, CIS countries, and Asia

In-Depth Information for Importers, Exporters & Global Buyers

Global buyers sourcing Theophylline Prolonged-Release Tablets 200mg need high-standard regulatory support, flexible packaging solutions, and consistent supply. Taj Pharma provides a complete export-ready solution.

Regulatory Documentation Provided by Taj Pharma

Taj Pharma offers a full regulatory dossier to support global registration:

• COA (Certificate of Analysis)

• WHO-GMP Certificate

• COPP Certificate

• CTD/ACTD Dossier

• Free Sale Certificate

• Stability Data (Zone III & IV)

• Batch Manufacturing & Packaging Records

• MSDS

• BE/Bioequivalence Data (where required)

Custom Packaging & Labeling Options

Buyers can request customized export packaging, including:

• Alu-Alu / Blister Packs

• HDPE / Bottle Packs

• Customized artwork for local regulatory compliance

• Multilingual labeling

• Branding support for PCD franchise requirements

Shelf Life, Storage & Dosage

• Shelf life: 24–36 months (country-specific)

• Storage: Store below 25°C, dry and cool place

• Dosage Form: Prolonged-release tablets 200mg

• Administration: Oral, once or twice daily as per prescription

Export Certifications from Taj Pharma

Taj Pharma facilities are accredited with:

• WHO-GMP certified manufacturing facilities

• ISO 9001:2015

• EU-GMP aligned processes

• UK-MHRA compliant infrastructure

• PIC/S standards

• US-FDA compliant quality systems

These certifications ensure regulatory acceptance across global markets.

Target Countries & Active Export Markets

Taj Pharma exports Theophylline Prolonged-Release Tablets 200mg to:

• Latin America

• Africa (East, West, South)

• Middle East & Gulf nations

• CIS Region

• Southeast Asia

• Europe (selected markets)

• Central America

• Caribbean Islands

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

Taj Pharma is recognized as the Top WHO-GMP Manufacturer of Theophylline Prolonged-Release Tablets 200mg in India due to its unmatched quality, affordability, and global supply capabilities.

1. State-of-the-Art Manufacturing Facilities

Located in Vapi, Gujarat, Taj Pharma operates advanced production units equipped with:

• Automated tablet compression lines

• HEPA-filtered clean rooms

• In-house microbiology & analytical laboratories

• Zero contamination processing environment

• Real-time monitoring & digital BMR documentation

2. Unmatched Quality Assurance

Quality is maintained through:

• Raw-material authentication

• In-process QC checks

• Finished product testing across 25+ parameters

• Stability and dissolution testing

• Impurity profiling

• Pharmacopoeial compliance (IP/USP/BP/EP)

3. Affordable Pricing for Global Buyers

Taj Pharma is known for offering cost-effective manufacturing and bulk export pricing thanks to:

• Economies of scale

• Optimized procurement networks

• Efficient logistics

• Export-focused supply chain

4. Global Presence & Supply Chain Strength

Taj Pharma supplies bulk volumes seamlessly, supported by:

• Export to Top 20 international markets

• Strong freight & logistics partnerships

• On-time delivery schedules

• 24×7 buyer support

• Country-specific regulatory assistance

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 Specifications

Call to Action

Looking for a reliable Theophylline Prolonged-Release Tablets 200mg Manufacturer and Supplier in India?

Taj Pharma is your trusted partner for:

• Bulk export orders

• Government tenders

• Private label/contract manufacturing

• PCD Pharma franchise supply

• Hospital procurement

• Customized export packaging

📩 Contact Taj Pharma Today:
Email: info@tajpharma.com
Website: www.tajpharma.com
Location: Vapi, Gujarat, India

Top 20 FAQs  

1. What are Theophylline Prolonged-Release Tablets 200mg used for?

They are used to treat asthma, COPD, chronic bronchitis, and emphysema.

2. Who is the best manufacturer in India?

Taj Pharma is widely recognized as the leading manufacturer due to WHO-GMP quality and global export support.

3. What is the shelf life?

Typically 24–36 months, depending on region.

4. Do you provide export documentation?

Yes, Taj Pharma provides WHO-GMP, COPP, CTD dossier, COA, FSC, MSDS, and more.

5. Is custom packaging available?

Yes — fully customizable for country regulations.

6. What pharmacopoeias are available?

IP/BP/USP as per buyer requirements.

7. What is the minimum order quantity?

MOQ depends on regulatory and packaging needs; bulk orders welcomed.

8. Do you export to Africa?

Yes, to more than 20 African nations.

9. Do the tablets have side effects?

Nausea, headache, vomiting, and insomnia may occur.

10. Are samples available?

Regulatory sample shipments can be arranged.

11. Can Taj Pharma supply tender quantities?

Yes, government tender capability is strong.

12. Is private labeling possible?

Yes, OEM/contract manufacturing is available.

13. How are the tablets packaged?

Alu-Alu blister or bottles, based on buyer preference.

14. Are Theophylline tablets safe for long-term use?

Yes, when used under healthcare supervision.

15. How do prolonged-release tablets work?

They deliver slow, steady medication release.

16. Are export prices competitive?

Taj Pharma offers highly competitive global pricing.

17. Does Taj Pharma follow GMP norms?

Yes, fully WHO-GMP & ISO certified.

18. What markets does Taj Pharma target?

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

19. Are stability studies available?

Yes, Zone III & IV stability data provided.

20. How can buyers contact Taj Pharma?

Via email, website, or corporate office in Vapi, India.

Taj Pharma stands as the 1 Theophylline Prolonged-Release Tablets 200mg Manufacturer in India, offering world-class manufacturing standards, unmatched quality assurance, global export capability, and buyer-friendly services. For pharmaceutical companies, distributors, importers, or PCD franchise operators, Taj Pharma is the ideal partner for sustained supply and competitive pricing.