Gemfibrozil Tablet 300mg

Gemfibrozil Tablet  300mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Gemfibrozil Tablet IP 300mg
• Gemfibrozil Tablet IP 600mg
• Gemfibrozil Tablet IP 900mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Gemfibrozil Tablet IP 300mg
  Each Film-coated tablet contains:
  Gemfibrozil IP…………….300mg
  Excipients…………………………….… q.s.
  Colour: Red Oxide iron
• Gemfibrozil Tablet IP 600mg
  Each Film-coated tablet contains:
  Gemfibrozil IP…………….600mg
  Excipients…………………………….… q.s.
  Colour: Sunset yellow
• Gemfibrozil Tablet IP 900mg
  Each Film-coated tablet contains:
  Gemfibrozil IP…………….900mg
  Excipients…………………………….… q.s.
  Colour: Quinoline Yellow

THERAPEUTIC INDICATIONS:

• Gemfibrozil is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood.

CAUTION & WARNING:

• CAUTION: Moisture sensitive tablets. Do not remove from strip until immediately before administration.
  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.
• Dosage:As directed by the physician.

Introduction to Gemfibrozil Tablet 300mg 

Gemfibrozil Tablet 300mg is a widely used lipid-regulating agent that plays a crucial role in managing cholesterol disorders. This medication decreases serum triglycerides and very-low-density lipoprotein (VLDL) cholesterol, while increasing high-density lipoprotein (HDL) cholesterol—often referred to as the “good” cholesterol. It is prescribed for individuals with hyperlipidemia to lower cardiovascular risk, particularly heart disease and stroke.

With cardiovascular diseases remaining a leading global health concern, Gemfibrozil Tablet 300mg is in consistent demand worldwide, especially in emerging and developed markets. Governments and healthcare providers are increasingly prioritizing affordable and quality lipid-lowering medicines, creating significant export opportunities for Gemfibrozil Tablet 300mg manufacturers in India.

Taj Pharma, a top pharmaceutical manufacturer in Vapi, Gujarat, has positioned itself as a WHO-GMP-certified leader in the production, supply, and export of Gemfibrozil Tablet 300mg to more than 40 countries.

In-Depth Details for Importers, Exporters & Global Buyers

When sourcing Gemfibrozil Tablet 300mg from India, buyers expect strict compliance with regulatory requirements, premium product quality, and flexibility in packaging. Taj Pharma delivers on all these aspects with unmatched consistency.

Regulatory Documentation Provided

Taj Pharma offers full export-ready documentation to ensure smooth global trade:

• WHO-GMP Certification

• EU-GMP Compliance

• Certificate of Pharmaceutical Product (COPP)

• CTD/ACTD Dossier Preparation

• Free Sale Certificate

• ISO 9001:2015 Certification

• Stability data & analytical test reports

Custom Packaging & Labeling

We offer private labeling and custom packaging solutions to meet market-specific requirements. Packaging formats include:

• Blister packs (Alu-Alu, PVC)

• Bulk packs for institutional supply

• Multilingual labels as per importing country norms

Shelf-life, Storage & Dosage Form

• Dosage Form: Oral tablet, 300mg

• Shelf Life: 24–36 months (country-specific stability studies available)

• Storage: Store in a cool, dry place, below 30°C, protected from light and moisture

Export Certifications

• WHO-GMP – Ensures global quality recognition

• EU-GMP – Meeting European regulatory standards

• COPP – Essential for product registration abroad

• CTD/ACTD Dossiers – Ready for fast-track market entry

Target Countries & Export Markets

Taj Pharma exports Gemfibrozil Tablet 300mg to:

• Asia: Vietnam, Philippines, Sri Lanka, Bangladesh

• Africa: Kenya, Nigeria, Tanzania, South Africa

• Middle East: UAE, Saudi Arabia, Oman

• CIS: Uzbekistan, Kazakhstan

• Latin America: Peru, Chile, Dominican Republic

Why  is the Most Trusted Gemfibrozil Tablet 300mg Manufacturer in India

 State-of-the-Art Manufacturing

Our WHO-GMP and EU-GMP certified plant in Vapi, Gujarat, is equipped with advanced production technology, stringent quality control labs, and automated packaging lines—ensuring precision in every batch.

 Affordable Pricing with Quality Assurance

We maintain cost-efficient manufacturing while never compromising on quality. Every batch undergoes:

• HPLC & UV spectroscopy testing

• Dissolution and disintegration analysis

• Microbial testing

 Global Presence & Supply Chain Support

Taj Pharma has a robust export network that guarantees timely deliveries to over 40 countries with temperature-controlled shipping and end-to-end logistics support.

 Top 20 Countries We Export Gemfibrozil Tablet 300mg To:

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specification 

If you are a global importer, distributor, or PCD pharma franchise seeker looking for a reliable Gemfibrozil Tablet 300mg manufacturer in India, Taj Pharma offers unmatched quality, competitive prices, and regulatory support for smooth market entry.

📩 Contact us today for bulk orders, private labeling, or distribution partnerships. Our regulatory team will provide full documentation support to fast-track your registrations.

Top 20 FAQs

1. What is Gemfibrozil Tablet 300mg used for?
It is used to lower triglycerides and LDL cholesterol while increasing HDL cholesterol.

2. How does Gemfibrozil work?
It works by reducing triglyceride production in the liver and increasing HDL levels.

3. Is Gemfibrozil Tablet 300mg manufactured in India?
Yes, leading companies like Taj Pharma produce it in WHO-GMP-certified plants.

4. What certifications are required for export?
WHO-GMP, COPP, and CTD dossiers are typically required for registration abroad.

5. Can Gemfibrozil be taken with food?
It can be taken with or without food but should be taken at the same time daily.

6. What is the shelf life?
24–36 months, depending on packaging and market requirements.

7. Is Gemfibrozil safe in pregnancy?
It may not be safe; consult a doctor before use.

8. Are there any common side effects?
Nausea, abdominal pain, diarrhea, and vomiting.

9. Does Taj Pharma offer private labeling?
Yes, with multilingual packaging options.

10. What is the MOQ for export orders?
Typically 100,000 tablets, but negotiable for certain markets.

11. Can Gemfibrozil be used in children?
It is generally not recommended for patients under 18 unless prescribed.

12. What is the standard dosage?
Usually 300mg twice daily, as prescribed by a doctor.

13. How is it stored?
Below 30°C, away from light and moisture.

14. Does Taj Pharma provide regulatory dossiers?
Yes, CTD/ACTD dossiers are available for quick registration.

15. Is Gemfibrozil available for PCD franchise?
Yes, Taj Pharma offers PCD franchise opportunities.

16. Which markets are best for Gemfibrozil exports?
High-demand regions include Africa, Asia, and Latin America.

17. Does Taj Pharma ship worldwide?
Yes, with complete logistics support.

18. Are stability studies available?
Yes, both real-time and accelerated studies are available.

19. What is the lead time for bulk orders?
4–6 weeks from purchase order confirmation.

20. Why choose Taj Pharma over other manufacturers?
Global reputation, WHO-GMP certification, competitive pricing, and regulatory expertise.