Roflumilast Tablet 500mcg

Roflumilast Tablet 500mcg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

•  Roflumilast Tablet 500mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Roflumilast Tablet  500mcg
  Each Uncoated Tablet Contains:
  Roflumilast IP…………………500mcg(microgram)
  Excipients…………………. q.s.

THERAPEUTIC INDICATIONS:

• Roflumilast is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV₁ post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment

CAUTION & WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
• 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 25˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
• Dosage:  As directed by the Physician.

Introduction to Roflumilast Tablet 500mcg

Roflumilast Tablet 500mcg is a highly prescribed medication for the prevention of chronic obstructive pulmonary disease (COPD) flare-ups. COPD is one of the leading global causes of morbidity and mortality, affecting millions of patients worldwide. Unlike quick-relief medicines, Roflumilast is a long-term management therapy that helps reduce inflammation in the lungs, lowers the risk of exacerbations, and improves lung function over time.

Belonging to the phosphodiesterase-4 (PDE4) inhibitor class, Roflumilast works by reducing lung inflammation at the cellular level. This results in fewer COPD-related complications and improved breathing for patients suffering from chronic bronchitis and recurrent flare-ups.

The medicine is available strictly on doctor’s prescription and should not be used for acute breathing attacks. With the growing burden of COPD globally, the demand for Roflumilast Tablet 500mcg has increased across international pharmaceutical markets, especially in regions like the Middle East, Africa, South America, and Southeast Asia.

Taj Pharma, a leading Roflumilast Tablet 500mcg manufacturer in India, has positioned itself as a reliable partner for global importers, wholesalers, and government procurement agencies.

 Key Uses and Benefits

• Prevents COPD exacerbations in severe chronic bronchitis patients

• Improves lung function within 6 months of therapy (as per clinical studies)

• Reduces frequency of flare-ups in high-risk COPD patients

• Helps decrease hospitalizations related to respiratory complications

• Enhances quality of life for COPD patients under long-term treatment

Details for Importers, Exporters, and Global Buyers

When procuring Roflumilast Tablet 500mcg for large-scale distribution, compliance, certifications, and packaging standards are crucial. Taj Pharma offers unmatched transparency and professional support for global buyers.

✅ Regulatory Documentation Provided

• WHO-GMP Certification

• EU-GMP compliance

• Certificate of Pharmaceutical Product (COPP)

• CTD Dossier (Common Technical Document)

• Drug Master File (DMF) support

• COA, MSDS, and stability reports

✅ Custom Packaging & Labeling

• Blister packs / Bottle packs

• Bulk packing for institutional buyers

• Custom labeling available in multiple languages (Arabic, French, Spanish, Russian, etc.)

• Packaging with track & trace serialization

✅ Shelf-life, Storage & Dosage Form

• Shelf-life: 24 to 36 months

• Storage: Store below 25°C in a dry place

• Dosage form: 500mcg film-coated tablets

✅ Export Certifications & Approvals

• WHO-GMP, EU-GMP approved facilities

• ISO 9001:2015 quality certifications

• PIC/S standards compliant

• Regulatory filing support for tenders and government supplies

✅ Target Export Markets

Taj Pharma actively exports Roflumilast Tablet 500mcg to:

• Latin America (Brazil, Peru, Chile, Argentina)

• Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia)

• Middle East (Saudi Arabia, UAE, Iraq, Yemen)

• Asia-Pacific (Vietnam, Philippines, Myanmar, Sri Lanka)

• CIS Countries (Ukraine, Russia, Kazakhstan, Uzbekistan)

Why is the Most Trusted Roflumilast Tablet 500mcg Manufacturer & Exporter

🌐 State-of-the-Art Manufacturing

Taj Pharma operates EU-GMP & WHO-GMP certified manufacturing units in Vapi, Gujarat, equipped with modern facilities that comply with global regulatory requirements.

💲 Affordable Pricing with Quality Assurance

• Competitive pricing for bulk buyers and government tenders

• Rigorous quality control and batch-wise testing

• Cost-effective solutions without compromising efficacy

🚀 Global Presence & Supply Chain Support

Taj Pharma exports to over 80 countries, offering seamless logistics, customs clearance documentation, and door-to-door supply chain solutions.

🌎 Top 20 Exporting Countries for Roflumilast Tablet 500mcg

Nigeria, Kenya, Ghana, South Africa, Tanzania, Uganda, Philippines, Vietnam, Myanmar, Sri Lanka, Nepal, UAE, Saudi Arabia, Iraq, Yemen, Kazakhstan, Uzbekistan, Peru, Bolivia, Chile

Technical Product Specification

Are you a global distributor, government procurement agency, or pharma importer looking for a trusted Roflumilast Tablet 500mcg manufacturer in India?

Taj Pharma offers:

• End-to-end regulatory support

• Best-in-class quality at competitive pricing

• Flexible packaging & labeling solutions

• On-time delivery worldwide

📞 Contact Taj Pharma today to discuss bulk supply, export, or PCD Pharma Franchise opportunities for Roflumilast Tablet 500mcg.

👉 Visit: www.tajpharma.com | ✉ Email: info@tajpharma.com

Top 20 FAQs

1. What is Roflumilast Tablet 500mcg used for?
It is prescribed to prevent COPD flare-ups in patients with severe chronic bronchitis.

2. Is Roflumilast a steroid?
No. It is a PDE4 inhibitor, not a steroid.

3. Can Roflumilast cure COPD?
No, it does not cure COPD but helps in managing and preventing flare-ups.

4. Is it safe for long-term use?
Yes, under strict medical supervision and weight monitoring.

5. How does Roflumilast work?
It reduces lung inflammation by inhibiting PDE4 enzyme activity.

6. Can it be used for asthma?
It is not approved for asthma treatment.

7. What are common side effects?
Headache, diarrhea, nausea, insomnia, and weight loss.

8. Is it safe for elderly patients?
Yes, but dosage must be monitored carefully.

9. Can pregnant women take Roflumilast?
It should be avoided unless prescribed by a doctor.

10. Is Roflumilast available over the counter?
No, it requires a doctor’s prescription.

11. What should I avoid while taking Roflumilast?
Avoid sudden discontinuation and monitor body weight regularly.

12. Can I take Roflumilast with other COPD medicines?
Yes, it is often prescribed along with bronchodilators or inhalers.

13. Is it safe for patients with depression?
Not recommended for those with a history of depression or suicidal thoughts.

14. What is the shelf-life of Roflumilast Tablet 500mcg?
Typically 24–36 months.

15. How should it be stored?
Keep below 25°C, away from moisture and sunlight.

16. Who manufactures Roflumilast Tablet 500mcg in India?
Taj Pharma Ltd, Vapi, Gujarat is a leading manufacturer.

17. Does Taj Pharma export Roflumilast Tablet 500mcg?
Yes, to over 80+ countries worldwide.

18. Can I get customized packaging for exports?
Yes, Taj Pharma offers custom labeling and packaging.

19. Is it included in government tenders?
Yes, Taj Pharma supplies to government healthcare projects globally.

20. How to buy Roflumilast Tablet 500mcg in bulk?
Contact Taj Pharma’s export division for wholesale and institutional supply.