Theophylline Extended-Release Tablets 600mg

Theophylline Extended-Release Tablets 600mg 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 600mg

Theophylline Extended-Release Tablets 600mg are a time-tested bronchodilator formulation used in the treatment and prevention of chronic obstructive pulmonary disease (COPD) and asthma. The medicine works by relaxing airway muscles, thereby easing breathing difficulties and preventing asthma attacks.

These extended-release tablets provide a sustained therapeutic effect, ensuring consistent control of respiratory symptoms throughout the day. As respiratory diseases continue to rise globally, the demand for high-quality, affordable Theophylline formulations has increased, particularly in emerging and low-income nations.

Taj Pharma, a WHO-GMP certified pharmaceutical manufacturer in India, stands out as one of the most reputable producers and exporters of Theophylline Extended-Release Tablets 600mg. Based in Vapi, Gujarat, Taj Pharma ensures international standards of safety, purity, and efficacy across every batch manufactured.

A Trusted Name in Global Pharmaceutical Manufacturing

Taj Pharma the well-known Theophylline Extended-Release Tablets 600mg Manufacturer in India gives the assurance of high-quality and purity. The company’s focus is on providing safe, effective, and affordable respiratory care solutions that meet international therapeutic standards.

Taj Pharma’s manufacturing facilities are EU-GMP, WHO-GMP, and ISO 9001:2015 certified, ensuring compliance with the highest levels of pharmaceutical quality control.

Each batch of Theophylline Extended-Release Tablets 600mg undergoes rigorous in-process checks and laboratory testing under the supervision of highly qualified experts, guaranteeing consistent quality, purity, and therapeutic value.

Mechanism of Action: 

Theophylline belongs to a class of drugs known as methylxanthines. It works as a bronchodilator, helping patients breathe easier by:

• Relaxing airway muscles, widening air passages in the lungs.

• Improving airflow, thereby reducing wheezing and breathlessness.

• Enhancing diaphragm strength, improving breathing efficiency.

The extended-release formulation ensures a controlled release of medication over time, maintaining optimal blood concentration for 12–24 hours.

This makes Theophylline Extended-Release Tablets 600mg especially effective in managing chronic respiratory conditions where consistent control is essential.

Uses and Therapeutic Benefits

Taj Pharma’s Theophylline Extended-Release Tablets 600mg are widely used for the:

• Prevention and treatment of asthma

• Management of chronic obstructive pulmonary disease (COPD)

• Reduction of nighttime asthma attacks

• Improvement of lung function and oxygen intake

• Relief from breathing discomfort caused by bronchospasm

The medicine should not be used for sudden asthma attacks, as it is designed for long-term control and maintenance therapy.

Common Side Effects

Most side effects of Theophylline Extended-Release Tablets 600mg are mild and temporary. They include:

• Nausea

• Vomiting

• Headache

• Insomnia (difficulty in sleeping)

• Nervousness or tremors

These effects typically resolve as the body adjusts to the medication. However, users should consult a healthcare provider if symptoms persist or worsen.

Taj Pharma provides detailed product leaflets with each batch, guiding patients and healthcare professionals on appropriate dosage, administration, and precautions.

Quality Manufacturing by Taj Pharma, Vapi – Gujarat, India

Taj Pharma’s state-of-the-art pharmaceutical facility in Vapi, Gujarat is equipped with advanced machinery, cleanroom environments, and modern packaging lines. Every product is made in accordance with international pharmacopeial standards (IP/BP/USP/EP).

Certifications and Regulatory Approvals:

• WHO-GMP Certified Facility

• ISO 9001:2015 Certified

• EU-GMP Compliant Manufacturing

• COPP (Certificate of Pharmaceutical Product)

• CTD Dossier Support for International Registration

• Regulatory Compliance with FDA & EMA Guidelines

Taj Pharma’s global clients benefit from comprehensive regulatory documentation, making import registration seamless in both regulated and semi-regulated markets.

Comprehensive Export & Supply Solutions for Importers and Buyers

Taj Pharma has established itself as a leading exporter of Theophylline Extended-Release Tablets 600mg to more than 45 countries.

Key Advantages for International Buyers:

• Custom Packaging & Labeling: Packaging tailored to regional language and regulatory requirements.

• Shelf-Life: 24–36 months (depending on storage conditions).

• Storage: Store below 30°C in a cool, dry place away from direct sunlight.

• Dosage Form: Film-coated extended-release tablets.

• Documentation Support: COPP, Free Sale Certificate, COA, MOA, Stability Data, CTD Dossier.

Target Export Markets:

• South Africa

• Kenya

• Nigeria

• Vietnam

• Myanmar

• Sri Lanka

• Cambodia

• Philippines

• UAE

• Saudi Arabia

• Oman

• Yemen

• Bangladesh

• Nepal

• Afghanistan

• Iraq

• Egypt

• Ghana

• Uganda

• Tanzania

Why is the Most Trusted Manufacturer and Exporter

1. Advanced Manufacturing Infrastructure:
Taj Pharma’s facilities feature automated production systems with strict environmental and quality control measures ensuring consistent excellence.

2. Affordable and Competitive Pricing:
As a leading bulk exporter and contract manufacturer, Taj Pharma offers competitive pricing without compromising on quality.

3. Global Supply Chain and On-Time Delivery:
Efficient logistics and export experience ensure timely shipment and reliable supply for importers and distributors worldwide.

4. Quality Assurance and Regulatory Strength:
Each product is manufactured under strict Good Manufacturing Practices (GMP) with batch-level documentation traceability.

5. Research and Innovation:
Taj Pharma invests in R&D and formulation development, enhancing drug efficacy and stability profiles to meet international expectations.

Technical Product Specification: 

Call to Action: Partner with Taj Pharma Today

Looking for a reliable Theophylline Extended-Release Tablets 600mg Manufacturer and Supplier in India?

Taj Pharma offers turnkey pharmaceutical export solutions including contract manufacturing, private labeling, and regulatory support. Importers, distributors, and healthcare procurement agencies are welcome to collaborate.

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

Partner with the #1 WHO-GMP Certified Manufacturer of Theophylline Extended-Release Tablets 600mg for guaranteed quality, compliance, and reliability.

Top 20 FAQs 

1. What is Theophylline Extended-Release Tablets 600mg used for?
It is used to treat and prevent asthma and chronic obstructive pulmonary disease (COPD).

2. How does Theophylline work?
It relaxes airway muscles, widening air passages for easier breathing.

3. Can Theophylline be used for sudden asthma attacks?
No, it is for long-term maintenance, not emergency use.

4. Who manufactures Theophylline 600mg Tablets in India?
Taj Pharma is the leading WHO-GMP certified manufacturer.

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

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

7. How should Theophylline Tablets be stored?
Store below 30°C in a cool, dry place away from sunlight.

8. Is Theophylline safe for children?
Use only under pediatrician guidance.

9. What is the shelf life?
24–36 months depending on storage.

10. Is customization available for packaging?
Yes, Taj Pharma offers private labeling and multilingual packaging.

11. Can importers get CTD Dossiers?
Yes, full regulatory documentation is available.

12. Does Taj Pharma export globally?
Yes, to over 45 countries across Asia, Africa, and the Middle East.

13. What makes Taj Pharma’s products unique?
High-quality formulations with global compliance.

14. How can I place a bulk order?
Contact Taj Pharma’s export team via email or website.

15. Are sample batches available?
Yes, for regulatory registration and evaluation.

16. What dosage forms are available?
Extended-release tablets in various strengths.

17. What is the manufacturing location?
Vapi, Gujarat, India.

18. Can Taj Pharma support new market registrations?
Yes, full support is offered for dossiers and submissions.

19. Are Taj Pharma products affordable?
Yes, competitively priced for global buyers.

20. Why choose Taj Pharma over others?
Because of proven reliability, certifications, and global trust in quality.