Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg)

Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg)
  Each film coated Bilayered tablet contains: 
  Rosuvastatin Calcium IP
  Equivalent to Rosuvastatin……………………..20mg
  Aspirin IP…………………………………………75mg
  Clopidogrel Bisulphate IP
  Equivalent to Clopidogrel………………………75mg
  Excipients…………………………………………q.s
  Colour: Quinoline Yellow WS

THERAPEUTIC INDICATIONS:

ASPIRIN+CLOPIDOGREL+ROSUVASTATIN is used to prevent myocardial infarction (heart attack), stroke, or peripheral vascular disease. It also lowers abnormally elevated cholesterol or fat levels (dyslipidemia) in the body.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablet to be swallowed as a whole, and not to be chewed or crushed. 

IMPORTANT: Do not take this product during the last three months of pregnancy unless directed by a physician. Aspirin taken near the time of delivery may cause bleeding problem to both mother and child. Not to be in children below 12 years of age except under medical advice.

SCHEDULE H PRESCRIPTION DRUG-WARNING: To be sold by retail on the prescription of a registered medical practitioner only. 

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 25℃.
Store in cool, dry & dark place.
Protect from Light & moisture.

Dosage: As directed by the Physician.

Introduction to Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg)

Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg) are a potent fixed-dose combination used primarily for secondary prevention of cardiovascular events in high-risk patients. This formulation combines:

• Rosuvastatin 20 mg — a high-efficacy statin for aggressive LDL-C lowering and plaque stabilization.

• Aspirin 75 mg — low-dose antiplatelet therapy to reduce thrombotic events.

• Clopidogrel 75 mg — a P2Y12 inhibitor that further prevents platelet aggregation.

Because cardiovascular disease remains the leading cause of death worldwide, demand for effective combination therapies — especially higher-strength statin regimens like 20 mg rosuvastatin — is growing rapidly across emerging and regulated markets. Providers increasingly prefer fixed-dose combinations that improve adherence, reduce pill burden, and simplify supply chains.

As a trusted Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg) Manufacturer in India, Taj Pharma supplies WHO-GMP conformant product batches to meet global demand.

Why Importers & Buyers Prefer the 20mg Combination

The 20 mg rosuvastatin dose is appropriate for patients who require more intensive lipid lowering than 10 mg can deliver — for example, patients with established coronary artery disease, high baseline LDL, or those who failed to reach targets on lower doses. Coupling rosuvastatin 20 mg with dual antiplatelet therapy (aspirin + clopidogrel) offers integrated lipid and thrombotic control suitable for secondary prevention post-ACS or after stent placement (as per treating physician’s guidance).

Benefits to buyers/importers:

• Higher clinical efficacy per tablet (reduces need for multiple drugs).

• Improved patient compliance with single-tablet therapy.

• Lower logistics cost vs. separate drug shipments.

• Strong market demand in secondary prevention protocols.

Comprehensive Export & Regulatory Support for Global Markets

Taj Pharma understands that international procurement requires meticulous documentation and compliance. For global buyers of Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg) the company supplies:

• WHO-GMP Certificate and manufacturing license.

• Certificate of Pharmaceutical Product (COPP) / Free Sale Certificate (FSC).

• Complete CTD dossier (module-wise technical documentation) for regulatory submissions.

• Batch manufacturing records (BMR), certificate of analysis (CoA), and stability data.

• Customs & export paperwork, HS codes, packing lists, and shipment tracking.

• Private label/contract manufacturing options and custom packaging (blister / alu-alu / bottles) with market-specific labeling.

Shelf life & storage: Typically 24–36 months; store in a cool, dry place (<30°C), away from direct sunlight and moisture.

Dosage form: Film-coated oral tablets for once-daily administration as prescribed.

The Trusted Manufacturer, Exporter & Supplier

Based in Vapi, Gujarat, Taj Pharma is a reputed manufacturer and exporter of cardiovascular fixed-dose combinations, with modern facilities and rigorous quality systems.

State-of-the-art Manufacturing

• WHO-GMP compliant production lines, automated tablet presses, coating units, and validated cleanrooms.

• Strict raw material controls and approved vendor programs to ensure API quality.

Robust Quality Assurance

• Complete in-house analytical lab for assay, dissolution, uniformity, impurities, and microbial testing.

• Stability chambers for accelerated and long-term studies per ICH guidelines.

Affordable, Competitive Pricing

• Economies of scale in India allow Taj Pharma to offer competitive prices without compromising quality — ideal for government tenders, distributors, and private label customers.

Global Supply Chain & Reach

• Proven exports to regulated and semi-regulated markets across Africa, Middle East, CIS, Latin America, and Asia.

• Logistics partners ensuring secure, temperature-controlled shipping and timely delivery.

Top Export Markets & Target Countries

Taj Pharma targets high-demand regions for cardiovascular drugs, including:

• Africa: Nigeria, Kenya, Ghana, Tanzania, Ethiopia.

• Asia: Myanmar, Vietnam, Philippines, Sri Lanka, Nepal.

• Middle East: Iraq, Jordan, Yemen.

• Latin America: Peru, Ecuador, Bolivia.

• CIS: Kazakhstan, Uzbekistan.

The company supports regulatory registration and dossier submission in these markets.

Product Technical Specification Table

Clinical Advice & Safety Notes (For Labeling / Inserts)

• Indication: For secondary prevention in patients at high risk of cardiovascular events — use only under physician supervision.

• Administration: Take once daily with food to reduce GI upset.

• Bleeding risk: Aspirin + Clopidogrel increase bleeding tendency; caution when shaving, using razors or sharp instruments; notify healthcare providers before surgery.

• Muscle symptoms: Statins can cause myopathy; report unexplained muscle pain, weakness, fever, or dark urine. Discontinue and consult physician if severe.

• Liver monitoring: Notify doctor if you experience jaundice, loss of appetite, or unusual fatigue.

• Pregnancy & lactation: Not recommended; consult physician if pregnancy is planned or suspected.

PCD Franchise, Third-Party Manufacturing & Private Label Options

Taj Pharma offers flexible business models:

• PCD pharma franchise with monopoly rights and marketing support.

• Third-party manufacturing / contract manufacturing for companies seeking reliable production.

• Private labeling with custom packaging and artwork compliant with target market regulations.

Benefits: guaranteed quality, timely supply, promotional material, and MOQ options adapted to distributors’ needs.

Top 20 FAQs  

1. What is this fixed-dose combination used for?
   Secondary prevention of heart attack and stroke in high-risk patients, combining lipid-lowering and dual antiplatelet therapies.

2. Who manufactures this product in India?
   Taj Pharma Ltd., Vapi, Gujarat, is a leading WHO-GMP manufacturer and exporter.

3. What is the strength offered?
   Rosuvastatin 20 mg + Aspirin 75 mg + Clopidogrel 75 mg per tablet.

4. Is this product WHO-GMP certified?
   Yes — Taj Pharma manufactures under WHO-GMP compliant conditions.

5. What packaging options are available?
   Blister packs (10×10), alu-alu, and bottles with custom labeling.

6. What export documents are provided?
   COPP, CoA, BMR, CTD dossier, WHO-GMP certificate, stability data, and FSC.

7. What are common side effects?
   Abdominal pain, headache, muscle pain, diarrhea, joint pain, dyspepsia, and increased bleeding risk.

8. Is private labeling available?
   Yes — Taj Pharma supports OEM/private label manufacturing.

9. Can hospitals and tenders buy in bulk?
   Yes — competitive pricing and bulk export support available.

10. Are stability studies provided?
    Yes — ICH-compliant stability data and shelf-life documentation are provided.

11. How to store the product?
    Below 30°C in a dry place, away from sunlight.

12. Can this be given to pregnant women?
    Use only if prescribed by a physician — generally not recommended during pregnancy.

13. Are API sources validated?
    Yes — all APIs are sourced from qualified vendors with CoA and testing.

14. How long is lead time for export orders?
    Varies by order size and destination; Taj Pharma coordinates logistics and documentation.

15. Does Taj Pharma handle registrations?
    Taj Pharma provides dossier and technical support to assist registration in target countries.

16. Can distributors get marketing support?
    Yes — promotional materials and technical leaflets are available.

17. Is the product suitable for post-stent patients?
    It may be appropriate under physician guidance; dual antiplatelet therapy decisions are clinical.

18. What is MOQ for private label?
    MOQ depends on product and market; contact sales for specific details.

19. How to contact Taj Pharma for procurement?
    Use the contact details in the CTA below for export inquiries.

20. Why choose Taj Pharma?
    For WHO-GMP quality, regulatory support, competitive pricing, and dependable international logistics.

Call to Action 

For bulk inquiries, OEM/private label requests, and regulatory support for Rosuvastatin + Aspirin + Clopidogrel Tablets (20mg+75mg+75mg), contact Taj Pharma’s export team:

Taj Pharma Ltd.
Plot No. 513, GIDC Estate, Vapi – 396195, Gujarat, India
📧  info@tajpharma.com
📞 +91 74 0000 9975 
🌐 www.tajpharma.in

Request a CTD dossier, price quotation, and sample availability today. Taj Pharma’s export specialists will guide you through registration, private labeling, and logistics.