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 300mg 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 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Theophylline Prolonged-Release Tablets 300mg
    Each Film-coated tablet contains:
    Theophylline IP……………..……..300mg
    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 300mg: 

Theophylline Prolonged-Release Tablets 300mg are an essential bronchodilator formulation widely prescribed for chronic respiratory disorders. The medication helps manage:

  • Asthma

  • Chronic Bronchitis

  • Chronic Obstructive Pulmonary Disease (COPD)

  • Emphysema

Theophylline works by relaxing smooth muscles in the airways, widening bronchial passages, and reducing breathing difficulty. Being a prolonged-release formulation, it ensures sustained drug release, longer therapeutic effect, and better symptom control.

Its global demand is rapidly increasing due to:

  • Rising asthma and COPD prevalence worldwide

  • Cost-effective treatment needs in developing countries

  • Growing preference for long-acting bronchodilators

  • Government tenders requiring affordable respiratory medicines

India, known as a hub of high-quality generic pharmaceuticals, is a major exporter of bronchodilator therapies. Taj Pharma stands out as the most renowned Theophylline Prolonged-Release Tablets 300mg Manufacturer in India, offering unmatched purity, compliance, and global export capabilities.


Leading Theophylline Prolonged-Release Tablets 300mg Manufacturer in India

Taj Pharma is a well-known Theophylline Prolonged-Release Tablets 300mg manufacturer, committed to quality, safety, and therapeutic accuracy. Manufactured in WHO-GMP-certified units in Vapi, Gujarat, each batch undergoes rigorous quality testing to ensure purity and consistency.

Theophylline Prolonged-Release Tablets produced by Taj Pharma are widely used in:

  • Treatment and prevention of COPD

  • Long-term asthma management

  • Reducing airway inflammation and bronchial spasms

As a bronchodilator, the medicine works by widening airways to make breathing easier.

Common side effects include:

  • Nausea

  • Vomiting

  • Headache

  • Insomnia

Taj Pharma ensures minimal side effects through strict in-process control and adherence to global pharmacopeia standards.


In-depth Details for Importers, Exporters & Global Pharmaceutical Buyers

1. Regulatory Documentation Provided

Taj Pharma supports international product registration with complete regulatory dossiers including:

  • WHO-GMP Certificate

  • EU-GMP (on request)

  • COPP (Certificate of Pharmaceutical Product)

  • CTD / ACTD Dossier

  • Batch Manufacturing Records (BMR)

  • COA, MOA, Stability Data

  • Free Sale Certificate

  • GMP Compliance Reports

These documents help importers achieve swift approvals across Asia, Africa, CIS, and Latin America.


2. Custom Packaging & Labeling Options

Taj Pharma offers global buyers:

  • Customized export packaging

  • Alu-Alu / Blister / Bulk Tablet Packs

  • Private label manufacturing

  • Buyer-specific branding

  • Multilingual labeling

  • Tamper-proof packaging

This ensures market-ready solutions tailored to each country’s regulatory requirements.


3. Shelf-Life, Storage & Dosage Form

Attribute Specification
Dosage Form Prolonged-Release Tablets
Strength 300mg
Shelf-Life 24–36 months
Storage Conditions Below 25°C, protect from moisture
Administration Oral, extended-release

4. Export Certifications

Taj Pharma holds globally accepted certifications:

  • WHO-GMP

  • ISO 9001:2015

  • GLP and GDP Compliance

  • COPP for various countries

  • CTD Dossiers for registration

This makes it one of the most reliable Theophylline Prolonged-Release Tablets 300mg exporters from India.


5. Global Export Markets & Target Countries

Taj Pharma exports Theophylline PR 300mg Tablets to:

  • Africa

  • Middle East

  • CIS Nations

  • Southeast Asia

  • Latin America

  • Caribbean

  • Eastern Europe

These markets appreciate India’s cost-effective, WHO-certified respiratory medicines.


Why Taj Pharma is the Most Trusted Theophylline Prolonged-Release Tablets 300mg Manufacturer & Exporter

1. World-Class State-of-the-Art Manufacturing

Taj Pharma’s facilities include:

  • WHO-GMP & Schedule M certified units

  • Automated production lines

  • Precision granulators and compression technology

  • Advanced quality-control laboratories

  • Controlled environment manufacturing zones

Every tablet ensures consistent potency and dissolution.


2. Affordable Pricing with No Compromise on Quality

Taj Pharma maintains:

  • Competitive global pricing

  • International pharmacopeia compliance

  • Strict raw material sourcing standards

This makes them the preferred choice for:

  • Tender suppliers

  • NGOs

  • Government buyers

  • Private distributors


3. Strong Global Presence & Seamless Supply Chain

The company offers:

  • Timely delivery

  • Complete export documentation

  • Temperature-controlled shipping

  • 24/7 logistics assistance

Their robust supply chain ensures uninterrupted medicine availability.


4. 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 Table  

Parameter Specification
Product Name Theophylline Prolonged-Release Tablets
Strength 300mg
Manufacturer Taj Pharma India
Form Prolonged-release tablet
Therapeutic Class Respiratory / Bronchodilator
Pack Type Blister / Alu-Alu / Bottle
Shelf-Life 24–36 Months
HSN Code 30049099
Indications Asthma, COPD, Chronic Bronchitis
Certification WHO-GMP, ISO, COPP
MOQ 100,000 Tablets
Export Ready? Yes (Dossier available)

Call to Action for Global Buyers & Distributors

Are you searching for the most reliable, WHO-GMP-certified Theophylline Prolonged-Release Tablets 300mg Manufacturer in India?

Taj Pharma is your ideal partner.

📌 For bulk orders, PCD franchise, or international registration support:

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

Taj Pharma guarantees:

  • High-quality products

  • Competitive pricing

  • Fast global delivery

  • Complete documentation

Partner with India’s most trusted pharmaceutical manufacturer today.


Top 20 FAQs 

1. What is Theophylline Prolonged-Release Tablets 300mg used for?

It is used to treat asthma, COPD, chronic bronchitis, and related respiratory disorders.

2. Who is the best manufacturer in India?

Taj Pharma is the leading Theophylline Prolonged-Release Tablets 300mg Manufacturer in India with WHO-GMP certification.

3. Are dossiers available for registration?

Yes, CTD/ACTD dossiers are available.

4. What is the shelf life?

24–36 months.

5. Is private labeling possible?

Yes, Taj Pharma offers custom branding and packaging.

6. What is the dosage form?

Prolonged-release tablet.

7. Does Taj Pharma export worldwide?

Yes, it exports to over 40+ countries.

8. What are the common side effects?

Nausea, headache, vomiting, insomnia.

9. Does Taj Pharma follow WHO-GMP guidelines?

Absolutely.

10. What markets import this product?

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

11. Can small distributors order?

Yes, minimum orders start at 100,000 tablets.

12. Is Theophylline 300mg effective for asthma?

Yes, it is widely used for asthma maintenance therapy.

13. What packaging options are available?

Blister, alu-alu, and bottle packing.

14. How long does shipping take?

Usually 2–4 weeks.

15. Are samples available?

Yes, for regulatory and evaluation purposes.

16. What certifications does Taj Pharma hold?

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

17. Do they offer third-party manufacturing?

Yes, under strict confidentiality.

18. Is the product export-ready?

Yes, with full documentation.

19. What is the route of administration?

Oral.

20. How to place an order?

Through email, website inquiry, or direct phone call.