Pirfenidone Tablets 801mg

Pirfenidone Tablets 801mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Pirfenidone Tablets 267mg
B) Pirfenidone Tablets 801mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Pirfenidone Tablets 267mg
Each film coated tablet contains:
Pirfenidone USP………………..267mg
Excipients………………………….q.s.
Colours: Lake of indigo carmine

B) Pirfenidone Tablets 801mg
Each film coated tablet contains:
Pirfenidone USP………………….801mg
Excipients…………………………….q.s.
Colours: Fast green FCF

THERAPEUTIC INDICATIONS:

Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis (scarring of the lungs with an unknown cause). Pirfenidone is in a class of medications called pyridones. It works by blocking the action of a certain natural substance in the body that is involved in causing fibrosis.

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 Pulmonogist only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician

Introduction to Pirfenidone Tablets 801mg

Pirfenidone Tablets 801mg are an essential therapy for Idiopathic Pulmonary Fibrosis (IPF), a serious lung disease characterized by progressive scarring and stiffness of lung tissues. Pirfenidone belongs to the pyridone class of medications and works by blocking the action of fibrogenic substances in the body, thereby slowing the progression of lung fibrosis.

With the global rise of IPF cases, demand for high-quality Pirfenidone tablets has increased significantly. Patients, healthcare providers, and distributors worldwide seek reliable and consistent suppliers and manufacturers. Taj Pharma has emerged as a trusted name in India for providing premium-grade Pirfenidone Tablets 801mg, meeting international regulatory standards and ensuring global availability.

Therapeutic Uses of Pirfenidone Tablets 801mg

Pirfenidone is primarily indicated for:

• Treatment of Idiopathic Pulmonary Fibrosis (IPF)

• Reducing lung function decline

• Slowing fibrosis progression

• Improving patients’ quality of life

Common side effects include:

• Nausea

• Rash

• Abdominal pain

• Diarrhea

• Fatigue

• Headache

• Vomiting

• Loss of appetite

• Heartburn

• Weight loss

• Joint pain

Serious adverse effects may include:

• Severe skin reactions like Stevens-Johnson Syndrome

• Toxic epidermal necrolysis

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Important Safety Guidelines

Before prescribing or using Pirfenidone 801mg, medical supervision is essential:

• Disclose any liver or kidney diseases to your doctor.

• Inform about all other medications being taken to avoid interactions.

• Avoid direct sun exposure; use protective clothing or sunscreen.

• Pregnant or breastfeeding patients should consult their physician before use.

Taj Pharma emphasizes strict adherence to safety and dosing recommendations, ensuring reliable IPF management.

For Importers, Exporters, and Buyers 

Taj Pharma is a well-established Manufacturer, Exporter, and Supplier of Pirfenidone Tablets 801mg from Vapi, Gujarat, India. Their global clients benefit from a wide range of regulatory, packaging, and export support services.

Regulatory Documentation Provided

• WHO-GMP Certificate

• EU-GMP Certification

• Certificate of Pharmaceutical Product (COPP)

• CTD / ACTD Dossier

• Certificate of Analysis (CoA)

• Stability and batch manufacturing records

• Free Sale Certificate

Custom Packaging & Labeling

• HDPE bottles, blister packs

• Tamper-proof and protective packaging

• Multilingual labeling and private label options

• Anti-counterfeit holographic seals

Shelf-Life, Storage & Dosage Form

• Shelf life: 24–36 months

• Storage: Below 25°C, dry, and away from sunlight

• Dosage Form: Film-coated tablets, 801mg

Export Certifications

• WHO-GMP & EU-GMP approved

• ISO 9001:2015 certified

• PIC/S compliant manufacturing

• FDA-ready dossiers for regulated markets

Target Countries & Export Markets

Taj Pharma exports to over 80 countries, including:

• USA, Canada, UK, Germany, France

• UAE, Saudi Arabia, Oman, Qatar

• Nigeria, Kenya, South Africa, Egypt

• Vietnam, Philippines, Sri Lanka, Bangladesh

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

1. State-of-the-Art Manufacturing Facilities

Taj Pharma’s advanced WHO-GMP and EU-GMP certified manufacturing units ensure each Pirfenidone Tablets 801mg batch meets global quality standards.

2. Affordable Pricing & Quality Assurance

Vertical integration, bulk raw material sourcing, and stringent QC procedures allow Taj Pharma to offer premium-grade Pirfenidone tablets at highly competitive prices without compromising quality.

3. Global Presence & Supply Chain Support

Taj Pharma provides end-to-end export assistance, including documentation, shipping, and customs clearance, ensuring timely delivery to global partners.

4. Top 20 Countries Exporting

Technical Product Specification Table

Call to Action for Buyers, Distributors, and Importers

If you are an importer, distributor, or PCD partner looking for a trusted Pirfenidone Tablets 801mg manufacturer in India, Taj Pharma is your ideal choice.

With premium quality, regulatory-compliant documentation, and global logistics support, Taj Pharma ensures consistent supply for international markets.

📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
🏢 Head Office: Vapi, Gujarat, India

Top 20 FAQs  

1. What is Pirfenidone 801mg used for?
It treats Idiopathic Pulmonary Fibrosis (IPF) by slowing lung scarring.

2. Who is the best manufacturer of Pirfenidone Tablets in India?
Taj Pharma is a WHO-GMP certified Pirfenidone Tablets 801mg manufacturer in India.

3. How does Pirfenidone work?
Blocks fibrogenic substances to slow lung tissue scarring.

4. What are common side effects?
Nausea, rash, diarrhea, fatigue, headache, weight loss, dizziness.

5. Can Pirfenidone cause serious reactions?
Yes, including Stevens-Johnson syndrome and DRESS; monitor with a doctor.

6. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma holds WHO-GMP and EU-GMP certifications.

7. What export documents are provided?
COPP, CTD dossier, CoA, Free Sale Certificate, stability data.

8. Which countries import from Taj Pharma?
Over 80 countries including USA, UK, Germany, UAE, Nigeria.

9. Shelf life of Pirfenidone Tablets 801mg?
24–36 months.

10. How should Pirfenidone be taken?
With food; swallow tablets whole without crushing.

11. Can Taj Pharma provide private labeling?
Yes, multilingual and customized labels available.

12. Is this product suitable for pregnant women?
Only under medical supervision.

13. Does Taj Pharma supply bulk orders?
Yes, large-scale export-ready supply available.

14. How is Pirfenidone stored?
Below 25°C, away from moisture and sunlight.

15. Does it require prescription?
Yes, only a physician can prescribe.

16. Are there franchise opportunities?
Yes, via PCD Pharma Franchise.

17. What precautions should patients follow?
Avoid direct sun, monitor liver/kidney function.

18. Can it interact with other medications?
Yes, inform the doctor about all medicines taken.

19. How long does shipping take internationally?
Typically 10–21 days, depending on destination and customs.

20. Why choose Taj Pharma for Pirfenidone Tablets 801mg?
Global reach, regulatory support, WHO-GMP quality, and competitive pricing.