Gemfibrozil Capsule 300mg

Gemfibrozil Capsule 300mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Gemfibrozil Capsule IP 300mg
  
• Gemfibrozil Capsule IP 600mg
• Gemfibrozil Capsule IP 900mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Gemfibrozil Capsule IP 300mg
  Each Hard Gelatin Capsule contains:
  Gemfibrozil IP…………….300mg
  Excipients…………………………….… q.s.
  Approved colors used in hard gelatin capsule shells.
•  b) Gemfibrozil Capsule IP 600mg
  Each Hard Gelatin Capsule contains:
  Gemfibrozil IP…………….600mg
  Excipients…………………………….… q.s.
  Approved colors used in hard gelatin capsule shells.
• c) Gemfibrozil Capsule IP 900mg
  Each Hard Gelatin Capsule contains:
  Gemfibrozil IP…………….900mg
  Excipients…………………………….… q.s.
  Approved colors used in hard gelatin capsule shells.

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 Capsule 300mg

Gemfibrozil Capsule 300mg is a lipid-regulating pharmaceutical formulation used primarily for the treatment of type IV hyperlipidemia — a condition characterized by very high triglyceride levels in the blood. It is prescribed for adult patients to lower their risk of cardiovascular diseases caused by excessive fats in the bloodstream.

The mechanism of action involves modifying lipid metabolism, thereby decreasing the concentration of triglycerides and very low-density lipoprotein (VLDL) while increasing high-density lipoprotein (HDL). Its clinical significance has made it a high-demand product in the global pharmaceutical industry.

Taj Pharma, the top Gemfibrozil Capsule 300mg Manufacturer in India, is a reputed name globally for delivering high-quality formulations that meet international standards.

In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

As a globally recognized pharmaceutical company, Taj Pharma supplies Gemfibrozil Capsule 300mg with complete regulatory and technical documentation:

• WHO-GMP Certificate

• EU-GMP Compliance Documentation

• Certificate of Pharmaceutical Product (COPP)

• CTD/ACTD Dossier

• Certificate of Analysis (COA)

• Stability Data (Zone II & IV)

• Manufacturing License

• Free Sale Certificate

• MSDS & Method of Analysis

These documents enable seamless drug registration and import clearance across global territories.

Custom Packaging & Labeling

Taj Pharma provides:

• Blister or strip packaging

• Secondary cartons with multilingual artwork

• Private label options for international clients

• Tamper-proof and moisture-resistant packs

• Packaging tailored to local market regulations

Shelf-Life, Storage, and Dosage Form

• Dosage Form: Hard Gelatin Capsules

• Strength: 300mg

• Shelf-life: 24–36 months

• Storage Condition: Store below 25°C in a dry place away from sunlight

• Administration Route: Oral

Export Certifications & Compliance

Taj Pharma’s facilities and processes are approved by:

• WHO-GMP

• EU-GMP

• NAFDAC (Nigeria)

• ANVISA (Brazil)

• TGA (Australia)

• SAHPRA (South Africa)

• FDA Philippines

• MOH approvals from various African & Asian countries

Target Countries & Export Markets

Taj Pharma exports Gemfibrozil Capsule 300mg to:

Myanmar, Egypt, Kenya, Nigeria, Vietnam, Iraq, Philippines, Sri Lanka, South Africa, UAE, Colombia, Saudi Arabia, Nepal, Afghanistan, Bangladesh, Yemen, Ghana, UK, Russia, Thailand

These countries depend on Taj Pharma for consistent supply, superior packaging, and affordable pricing.

Why Taj Pharma is the Most Trusted Gemfibrozil Capsule 300mg Manufacturer & Exporter

State-of-the-Art Manufacturing Facilities

Taj Pharma operates a WHO-GMP and EU-GMP compliant production plant in Vapi, Gujarat, India, equipped with:

• Fully automated production lines

• Dedicated QC & QA labs

• Skilled pharmaceutical scientists

• ISO 9001:2015 certified systems

• Dust-free, cleanroom environments (Class 100,000 to Class 100)

Affordable Pricing & Quality Assurance

As a bulk Gemfibrozil Capsule 300mg Supplier, Taj Pharma ensures cost-effective pricing by:

• In-house API sourcing

• High-volume production efficiency

• Minimizing wastage through lean management

• Offering best price without sacrificing quality

Each batch is tested for:

• Purity & potency

• Microbial load

• Uniformity

• Heavy metals & residual solvents

Global Presence & Logistic Support

With a footprint in 85+ countries, Taj Pharma offers:

• Support for registration dossiers

• Air & sea freight options

• International documentation packages

• Quick dispatch timelines

• Multi-modal logistics support

Top 20 Export Destinations

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

 Technical Specification

If you’re a pharma distributor, government procurement officer, hospital chain buyer, or PCD franchisee, partner with Taj Pharma to source Gemfibrozil Capsule 300mg that’s:

• WHO-GMP certified

• Competitively priced

• Backed by full regulatory support

• Globally exported

📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📍 Location: Vapi, Gujarat, India

Get in touch to request samples, pricing quotes, or regulatory dossiers.

Top 20 FAQs 

Q1. What is Gemfibrozil Capsule 300mg used for?
A: It treats very high triglyceride levels (type IV hyperlipidemia) and helps prevent heart disease.

Q2. Is Gemfibrozil a statin?
A: No, it belongs to the fibrates class, not statins.

Q3. Can Gemfibrozil cause kidney issues?
A: It should be avoided in severe kidney conditions; consult your doctor.

Q4. What are the common side effects?
A: GI disturbances like diarrhea, nausea, dyspepsia, and flatulence.

Q5. Is it safe to use with alcohol?
A: No, alcohol may worsen liver and kidney strain.

Q6. What’s the typical dosage?
A: Usually 300mg twice daily before meals, as prescribed.

Q7. Can creatinine levels normalize with treatment?
A: Yes, if elevated due to temporary factors like dehydration.

Q8. Is the medicine available for PCD franchise?
A: Yes, Taj Pharma offers it under PCD & private label models.

Q9. Can it be used in pregnancy?
A: Not recommended unless clearly needed and approved by a doctor.

Q10. Does Taj Pharma export this formulation globally?
A: Yes, Taj Pharma exports to 80+ countries with proper certifications.

Q11. Is Gemfibrozil 300mg manufactured in Mumbai?
A: It’s manufactured in Vapi but supplied across Mumbai and India.

Q12. What is the shelf life?
A: 24 to 36 months, depending on packaging and batch.

Q13. Are lab tests needed during treatment?
A: Yes, periodic liver and kidney function monitoring is advised.

Q14. Can this drug cause fatigue?
A: Fatigue may occur due to underlying lipid disorders or side effects.

Q15. Does Taj Pharma offer custom labeling?
A: Yes, private label packaging is available for partners worldwide.

Q16. What is the lead time for exports?
A: Generally 2–4 weeks depending on the order size.

Q17. Can I get samples for testing?
A: Yes, B2B samples can be provided on request.

Q18. Is the formulation WHO-GMP certified?
A: Absolutely, all batches comply with WHO-GMP and EU-GMP norms.

Q19. Can Taj Pharma assist with local registrations?
A: Yes, full regulatory dossiers and support are provided.

Q20. How do I place a bulk order?
A: Visit www.tajpharma.com or email info@tajpharma.com.