GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Anagrelide Capsules USP 0.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Anagrelide Capsules USP 0.5mg
Each hard Gelatin Capsule contains:
Anagrelide Hydrochloride USP
Equivalent to
Anagrelide Base……………………..0.5mg
Excipients……………………………….q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Anagrelide is used to decrease the risk of blood clots in patients who have thrombocythemia (too many platelets in the blood). It works to decrease the production of platelets in the body.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINE IN THE USP, WITH A CHILD RESISTANT CLOSURE AS REQUIRED.
TOTAL DAILY DOSE SHOULD NOT EXCEED 10MG.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Anagrelide Capsules 0.5mg Technical Specification:

Product Name: Anagrelide Capsules USP
Brand Name: Generic
Strength: (0.5mg)
Dosage Form: Capsules (Hard-Gelatin)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anticoagulant
Indication: Anagrelide is used to decrease the risk of blood clots in patients who have thrombocythemia (too many platelets in the blood). It works to decrease the production of platelets in the body.
Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Anagrelide Capsules USP 0.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Anagrelide Capsules USP 0.5mg
Each hard Gelatin Capsule contains:
Anagrelide Hydrochloride  USP
Equivalent to
Anagrelide Base……………………..0.5mg
Excipients……………………………….q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Anagrelide is used to decrease the risk of blood clots in patients who have thrombocythemia (too many platelets in the blood). It works to decrease the production of platelets in the body.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Dispense in a tight, light-resistant container as define in the USP, with a child resistant closure as required.
Total daily dose should not exceed 10mg.

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]
Protect from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction to Anagrelide Capsules 0.5mg

What is Anagrelide?

Anagrelide is a cytoreductive agent that works by decreasing the production of platelets in the bone marrow. It is particularly beneficial for patients diagnosed with:

  • Essential thrombocythemia (ET)

  • High-risk patients with cardiovascular complications

By controlling platelet counts, it reduces the risk of blood clots and related health issues.

Global Demand

The demand for Anagrelide Capsules 0.5mg is increasing due to:

  • Rising prevalence of thrombocythemia and related disorders

  • Awareness of thrombotic complications in high-risk patients

  • Growing adoption of generics in emerging markets

  • Affordable supply from WHO-GMP certified manufacturers like Taj Pharma


In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

Taj Pharma ensures full compliance with international standards. Documentation includes:

  • WHO-GMP Certification

  • EU-GMP Certification

  • Certificate of Pharmaceutical Product (COPP)

  • CTD/ACTD Dossiers for regulatory submissions

  • Free Sale Certificate (FSC)

  • Batch Manufacturing Records (BMR/BPR)

  • Material Safety Data Sheet (MSDS)

  • Stability and Quality Reports

This enables smooth import, export, and registration processes worldwide.


 Custom Packaging & Labeling

Buyers can request:

  • Alu-Alu blister packs or HDPE bottles

  • Custom labeling and private brand packaging

  • Multi-lingual packaging for target countries

  • Serialization and barcoding for regulatory compliance


Shelf-Life, Storage & Dosage Form

Parameter Details
Dosage Form Capsule
Strength 0.5mg
Shelf Life 24–36 months
Storage 15–30°C, cool, dry place
Packaging Blister packs / Bottles

Usage Advice:

  • Take exactly as prescribed by a physician

  • Avoid overdose

  • Monitor platelet counts regularly


Export Certifications

Taj Pharma’s global certifications ensure quality assurance:

  • WHO-GMP Certified

  • ISO 9001:2015 Quality Management

  • ISO 14001 Environmental Compliance

  • GLP Certified Laboratories


 Target Countries & Export Markets

Taj Pharma exports Anagrelide Capsules 0.5mg to over 80 countries, including:

  • UAE

  • Saudi Arabia

  • Nigeria

  • Kenya

  • Tanzania

  • Bangladesh

  • Sri Lanka

  • Vietnam

  • Philippines

  • European Union countries

These countries rely on Taj Pharma’s reliable supply chain and high-quality products.


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

 1. State-of-the-Art Manufacturing

  • Fully WHO-GMP compliant facility in Vapi, Gujarat

  • Advanced automated capsule filling and coating lines

  • Dedicated R&D and quality control laboratories

  • ISO-certified production units


2. Affordable Pricing with Quality Assurance

Taj Pharma provides:

  • Cost-effective bulk supply

  • High-purity API sourced from trusted vendors

  • Stability-tested and contamination-free capsules

  • Strict quality checks to maintain consistency


 3. Global Presence & Supply Chain Support

  • Timely delivery to international buyers

  • Assistance in product registration and regulatory approval

  • Logistics support with all necessary documentation


Top 20 Countries Exported

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia


Technical Product Specification Table

Specification Details
Product Name Anagrelide Capsules 0.5mg
Manufacturer Taj Pharma, India
Dosage Form Capsule
Strength 0.5mg
Pack Size 10×10 / Customized
Storage 15–30°C, dry place
Shelf Life 24–36 months
Regulatory WHO-GMP, COPP, CTD Dossier

Call to Action 

Global distributors, importers, and pharma buyers can secure high-quality Anagrelide Capsules 0.5mg with Taj Pharma.

📩 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📦 Request Free Samples, COA, and Dossier Today


 Top 20 FAQs  

  1. What is Anagrelide used for?
    To reduce high platelet counts in thrombocythemia patients.

  2. Is Taj Pharma WHO-GMP certified?
    Yes, with full compliance for international exports.

  3. Recommended dosage?
    As prescribed by your physician; typically 0.5mg capsules.

  4. Can it be taken with food?
    Yes, it can be taken with or without meals.

  5. Common side effects?
    Upset stomach, dry mouth, drowsiness.

  6. Can alcohol be consumed during treatment?
    Limit or avoid alcohol to prevent complications.

  7. Shelf life of capsules?
    24–36 months when stored properly.

  8. Stability reports available?
    Yes, real-time and accelerated stability data are provided.

  9. Can it be shipped internationally?
    Yes, Taj Pharma exports to over 80 countries.

  10. Is private labeling available?
    Yes, with customized packaging options.

  11. Can children take it?
    Only under strict medical supervision.

  12. Can it interact with other medications?
    Yes, consult a physician for drug interactions.

  13. How long is the treatment course?
    Depends on platelet levels and physician recommendation.

  14. Does it cure thrombocythemia?
    It controls platelet counts but does not cure the underlying condition.

  15. Are bulk orders accepted?
    Yes, Taj Pharma accommodates large-scale orders.

  16. Does it prevent strokes or heart attacks?
    By controlling platelets, it reduces associated risks.

  17. Storage conditions?
    Store in a cool, dry place below 30°C.

  18. Packaging options?
    Blister packs, bottles, and customized OEM packaging available.

  19. Is it safe for long-term use?
    Long-term use requires regular monitoring by a physician.

  20. Why choose Taj Pharma?
    For superior quality, WHO-GMP compliance, global reliability, and competitive pricing.