Gliclazide Tablets 80mg

Gliclazide Tablets  80mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Gliclazide Tablets IP 40mg
  
• Gliclazide Tablets IP 80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Gliclazide Tablets IP 40mg
  Each uncoated tablet contains:
  Gliclazide IP……………………40mg
  Excipients…………………………q.s.
• b) Gliclazide Tablets IP 80mg
  Each uncoated tablet contains:
  Gliclazide IP……………………80mg
  Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

• Gliclazide is used to treat type 2 diabetes. It’s a medicine known as a sulfonylurea. Sulfonylureas increase the amount of insulin your pancreas makes. This lowers your blood sugar.

CAUTION & WARNING:

• CAUTION:
  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 25˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
• Dosage:  As directed by the Physician.

Introduction to Gliclazide Tablets 80mg

Gliclazide Tablets 80mg are a widely prescribed anti-diabetic medicine used in the management of Type 2 Diabetes Mellitus (T2DM) in adults. Belonging to the class of sulfonylureas, Gliclazide works by stimulating the pancreas to release more insulin, thereby lowering blood sugar levels. This helps reduce the risk of diabetes-related complications, including kidney damage, blindness, nerve problems, and cardiovascular disease.

The global demand for Gliclazide Tablets 80mg continues to rise due to the increasing prevalence of diabetes worldwide. With more than 500 million people affected globally, the need for safe, affordable, and effective oral hypoglycemic agents is critical. Countries in Asia, Africa, the Middle East, and Latin America especially rely on Indian manufacturers like Taj Pharma for bulk supply and affordable generic versions.

Taj Pharma, headquartered in Vapi, Gujarat, is one of the leading manufacturers, exporters, and suppliers of Gliclazide Tablets 80mg with a proven record of quality, compliance, and global customer trust.

In-Depth Details for Importers, Exporters, and Global Buyers

For international distributors and pharmaceutical companies, partnering with a WHO-GMP-certified manufacturer like Taj Pharma ensures seamless supply, high-quality compliance, and smooth regulatory approvals.

Regulatory Documentation Provided

Taj Pharma provides all necessary regulatory support documents for Gliclazide Tablets 80mg, including:

• Certificate of Pharmaceutical Product (CoPP)

• WHO-GMP certification

• EU-GMP certification (for regulated markets)

• CTD / ACTD Dossier

• Free Sale Certificate

• Stability Data

• Manufacturing License and Drug Master File (DMF)

Custom Packaging & Labeling

Taj Pharma specializes in offering customized packaging and private labeling solutions tailored for local regulatory requirements. This includes:

• Blister packs, strip packs, bottles, or bulk packaging

• Multilingual labeling (English, French, Arabic, Spanish, etc.)

• Anti-counterfeit packaging solutions

• Country-specific regulatory-compliant artwork

Shelf-Life, Storage, Dosage Form

• Dosage Form: Oral solid tablets

• Strength: 80mg

• Shelf-Life: 24–36 months (depending on packaging)

• Storage: Store in a cool, dry place below 25°C, protected from light and moisture

Export Certifications

Taj Pharma is globally recognized for its compliance with stringent pharmaceutical standards. Key certifications include:

• WHO-GMP (World Health Organization Good Manufacturing Practice)

• EU-GMP (European Union Good Manufacturing Practice)

• ISO 9001:2015

• COA (Certificate of Analysis) & Stability Reports

• USFDA and MHRA compliant facilities

Target Countries & Export Markets

Taj Pharma exports Gliclazide Tablets 80mg to over 40+ countries, including:

• African Markets: Nigeria, Kenya, Tanzania, Ghana, South Africa

• Middle East: UAE, Saudi Arabia, Oman, Iraq

• Latin America: Brazil, Mexico, Peru, Chile

• Asian Markets: Vietnam, Philippines, Sri Lanka, Bangladesh

• CIS Countries: Ukraine, Kazakhstan, Uzbekistan

Why is the Most Trusted Manufacturer, Supplier, and Exporter

Taj Pharma has built a reputation as a global leader in pharmaceutical manufacturing with a strong focus on diabetes care. Here’s why global buyers and importers trust Taj Pharma:

1. State-of-the-Art Manufacturing

• WHO-GMP, EU-GMP, and ISO-certified facilities in Vapi, Gujarat

• Automated, sterile, and compliant production units

• Strict adherence to ICH guidelines and pharmacopoeia standards (USP, BP, IP, EP)

2. Affordable Pricing & Quality Assurance

• Competitive pricing without compromising on quality

• Dedicated Quality Assurance (QA) and Quality Control (QC) teams

• Batch-to-batch consistency with validated manufacturing processes

3. Global Presence & Supply Chain Support

• Strong distribution network covering Asia, Africa, Latin America, and CIS

• Flexible shipping: Air freight, sea freight, and courier options

• Export support with end-to-end logistics and customs clearance

4. Top 20 Export Countries

Taj Pharma currently exports to over 20+ leading international markets, including:

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 

If you are a pharmaceutical distributor, importer, or PCD franchise seeker, Taj Pharma is your trusted partner for Gliclazide Tablets 80mg manufacturing and exports from India.

✅ WHO-GMP & EU-GMP Certified
✅ Competitive Global Pricing
✅ Flexible Packaging & Private Labeling
✅ 20+ Countries Export Network

📩 Contact Taj Pharma Today for bulk supply, export inquiries, or collaboration opportunities.
👉 Visit: www.tajpharma.com

Top 20 FAQs  

1. What is Gliclazide Tablets 80mg used for?

It is used to treat Type 2 Diabetes Mellitus by controlling blood sugar levels.

2. How does Gliclazide 80mg work?

It stimulates the pancreas to release insulin, lowering blood sugar.

3. Who manufactures Gliclazide Tablets 80mg in India?

Taj Pharma is a leading Gliclazide Tablets 80mg manufacturer in India with WHO-GMP and EU-GMP certification.

4. What certifications does Taj Pharma provide?

WHO-GMP, EU-GMP, CoPP, CTD Dossier, ISO, and stability data.

5. Can Gliclazide be used in Type 1 Diabetes?

No, it is only for Type 2 Diabetes Mellitus.

6. What are the side effects?

Common side effects include nausea, diarrhea, constipation, stomach ache, and dizziness.

7. What is the shelf life of Gliclazide Tablets 80mg?

Typically 24–36 months, depending on packaging.

8. How should it be stored?

Store in a cool, dry place below 25°C away from moisture and sunlight.

9. Can Taj Pharma provide private labeling?

Yes, Taj Pharma offers custom packaging & labeling for global markets.

10. Is it safe for patients with kidney disease?

Use with caution; consult a doctor before prescribing to patients with renal impairment.

11. How is Gliclazide different from Metformin?

Gliclazide stimulates insulin release, while Metformin reduces glucose production in the liver.

12. What is the dosage of Gliclazide Tablets 80mg?

Usually 40–160 mg per day in divided doses, as prescribed by a doctor.

13. Does Taj Pharma export to Africa?

Yes, Taj Pharma exports extensively to Nigeria, Kenya, Ghana, and South Africa.

14. Can distributors order in bulk?

Yes, bulk supply and custom pack sizes are available.

15. What pharmacopoeias are followed?

USP, BP, IP, and EP standards as per client requirement.

16. Is Gliclazide safe in pregnancy?

No, it should not be used during pregnancy without medical advice.

17. Does Taj Pharma provide a CTD Dossier?

Yes, full regulatory dossiers are available for registrations.

18. Can I get Gliclazide Tablets 80mg at the best price in India?

Yes, Taj Pharma offers competitive pricing for local and export markets.

19. What packaging options are available?

Blisters, bottles, and bulk packs with country-specific labeling.

20. Why choose Taj Pharma for Gliclazide Tablets 80mg?

Because of quality manufacturing, global reach, regulatory support, and affordable pricing.