Amlodipine and Valsartan Tablets 10mg+160mg

Amlodipine and Valsartan Tablets  10mg+160mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Amlodipine and Valsartan Tablets USP 5mg+80mg
2. Amlodipine and Valsartan Tablets USP 5mg+160mg
3. Amlodipine and Valsartan Tablets USP 5mg+320mg
4. Amlodipine and Valsartan Tablets USP 10mg+160mg
5. Amlodipine and Valsartan Tablets USP 10mg+320mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Amlodipine and Valsartan Tablets USP 5mg+80mg
Each film-coated tablet contains:
Amlodipine Besylate USP 6.9mg
Equivalent to Amlodipine………………5mg
Valsartan USP………………………………80mg
Excipients………………………………………q.s
Colour: Ponceau 2R

2. Amlodipine and Valsartan Tablets USP 5mg+160mg
Each film-coated tablet contains:
Amlodipine Besylate USP 6.9mg
Equivalent to Amlodipine……………………5mg
Valsartan USP……………………………………..160mg
Excipients…………………………………………….q.s
Colour:  Orange G

3. Amlodipine and Valsartan Tablets USP 5mg+320mg
Each film-coated tablet contains:
Amlodipine Besylate USP 6.9mg
Equivalent to Amlodipine……………………5mg
Valsartan USP………………………………………320mg
Excipients……………………………………………..q.s
Colour: Red Oxide of Iron

4. Amlodipine and Valsartan Tablets USP 10mg+160mg
Each film-coated tablet contains:
Amlodipine Besylate USP 13.9mg
Equivalent to Amlodipine……………………10mg
Valsartan USP………………………………………160mg
Excipients………………………………………………q.s
Colour: Caramel

5. Amlodipine and Valsartan Tablets USP 10mg+320mg
Each film-coated tablet contains:
Amlodipine Besylate USP 13.9mg
Equivalent to Amlodipine………………10mg
Valsartan USP…………………………………320mg
Excipients…………………………………………q.s
Colour: Ferric oxide yellow

THERAPEUTIC INDICATIONS:

Amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

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 defined in the USP with a child-resistant closure.
Keep the container tightly closed.

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) ; excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction to Amlodipine and Valsartan Tablets 10mg+160mg

Amlodipine and Valsartan Tablets 10mg+160mg are a trusted combination medicine used in the effective management of hypertension (high blood pressure). Hypertension is a growing global health concern affecting millions of people worldwide, and combination therapies are considered more effective than monotherapy in achieving consistent blood pressure control.

This combination contains:

• Amlodipine (10mg): A calcium channel blocker (CCB) that relaxes blood vessels, making it easier for the heart to pump blood.

• Valsartan (160mg): An angiotensin receptor blocker (ARB) that prevents the constriction of blood vessels, lowering overall blood pressure.

Together, these two drugs work synergistically to improve cardiovascular health, reduce the risk of stroke, heart attack, and kidney damage, and provide patients with more stable blood pressure control.

Globally, the demand for Amlodipine and Valsartan Tablets 10mg+160mg is steadily rising, especially in developing countries where the prevalence of hypertension is increasing due to urban lifestyles, stress, and dietary changes.

In-depth Details for Importers/Exporters/Buyers

When sourcing Amlodipine and Valsartan Tablets 10mg+160mg manufacturer in India, global buyers prioritize regulatory compliance, product quality, and supply consistency. Taj Pharma ensures that all international pharmaceutical buyers receive end-to-end support.

1. Regulatory Documentation Provided

Taj Pharma provides complete export documentation including:

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (CoA)

• WHO-GMP and EU-GMP certificates

• Drug Master File (DMF) and CTD dossiers

• Free Sale Certificate

• Stability data and regulatory support documents

2. Custom Packaging & Labeling

Buyers benefit from customized packaging and labeling solutions tailored to specific market requirements. Taj Pharma adheres to country-specific language, design, and compliance needs, ensuring smooth registrations and product acceptance.

3. Shelf-life, Storage, and Dosage Form

• Shelf-life: 24–36 months depending on country guidelines

• Storage: Store below 30°C, protect from moisture and sunlight

• Dosage Form: Film-coated tablets in blister packs/bottle packs

4. Export Certifications

Taj Pharma’s facilities are certified by:

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

• EU-GMP (European Union Good Manufacturing Practice)

• ISO 9001:2015 for quality management

• CTD Dossier availability for regulated markets

5. Target Countries & Export Markets

Taj Pharma exports to more than 40 countries, including:

• Africa: Nigeria, Kenya, South Africa, Ghana, Ethiopia

• Asia: Vietnam, Philippines, Myanmar, Sri Lanka, Bangladesh

• Middle East: UAE, Iraq, Saudi Arabia, Yemen, Jordan

• Latin America: Peru, Bolivia, Guatemala, Dominican Republic

• CIS & Eastern Europe: Russia, Ukraine, Kazakhstan

Why is the Most Trusted Manufacturer, Supplier, and Exporter

When choosing an Amlodipine and Valsartan Tablets 10mg+160mg manufacturer in India, buyers need reliability, consistent quality, and strong global supply capabilities. Taj Pharma meets and exceeds these requirements.

1. State-of-the-Art Manufacturing

• WHO-GMP and FDA-compliant facilities in Vapi, Gujarat, India.

• Automated production lines ensuring uniformity and contamination-free products.

• Dedicated R&D team for continuous innovation.

2. Affordable Pricing & Quality Assurance

• Competitive pricing models without compromising on purity, potency, or safety.

• Multi-layered quality checks from raw materials to finished packaging.

• Compliance with ICH, PIC/S, and international pharmacopoeias.

3. Global Presence & Supply Chain Support

• Strong logistics network ensuring timely deliveries.

• Partnerships with distributors, PCD franchise partners, and global importers.

• Active participation in international tenders and government supply programs.

4. Top 20 Countries Exporting

1. Nigeria

2. Kenya

3. Vietnam

4. Sri Lanka

5. Philippines

6. UAE

7. Saudi Arabia

8. South Africa

9. Iraq

10. Jordan

11. Myanmar

12. Ghana

13. Ethiopia

14. Russia

15. Ukraine

16. Peru

17. Bolivia

18. Bangladesh

19. Guatemala

20. Kazakhstan

Technical Product Specification Table

Looking for a leading Amlodipine and Valsartan Tablets 10mg+160mg manufacturer in India?
Partner with Taj Pharma, India’s most trusted exporter and supplier of high-quality generic medicines.

📞 Contact Taj Pharma today to discuss supply agreements, PCD franchise opportunities, and bulk export collaborations. Your trusted partner for affordable and globally compliant pharmaceuticals.

Top 20 FAQs  

Q1: What are Amlodipine and Valsartan Tablets 10mg+160mg used for?
A: They are prescribed for managing high blood pressure and preventing cardiovascular complications.

Q2: Who manufactures Amlodipine and Valsartan Tablets 10mg+160mg in India?
A: Taj Pharma is the leading WHO-GMP certified manufacturer in India.

Q3: How do Amlodipine and Valsartan work together?
A: Amlodipine relaxes blood vessels, while Valsartan prevents narrowing of blood vessels, resulting in improved blood flow.

Q4: What are common side effects?
A: Dizziness, edema, headache, and fatigue.

Q5: Can I buy these tablets for export markets?
A: Yes, Taj Pharma exports to 40+ countries globally.

Q6: What certifications does Taj Pharma hold?
A: WHO-GMP, EU-GMP, ISO 9001:2015, CTD Dossier availability.

Q7: Is custom packaging available?
A: Yes, packaging and labeling can be customized per market.

Q8: What is the shelf life?
A: 24–36 months.

Q9: Are these tablets available under PCD Pharma Franchise?
A: Yes, Taj Pharma offers PCD franchise opportunities PAN India.

Q10: Are these medicines affordable?
A: Yes, Taj Pharma ensures competitive pricing.

Q11: Can they be combined with other medicines?
A: Only under physician guidance.

Q12: Does Taj Pharma supply to government tenders?
A: Yes, Taj Pharma actively participates in tenders worldwide.

Q13: Can distributors from Africa import directly?
A: Yes, Taj Pharma exports widely to African markets.

Q14: Is there risk of drowsiness?
A: Mild dizziness may occur, so avoid driving initially.

Q15: Where is Taj Pharma based?
A: Vapi, Gujarat, India.

Q16: How long does it take to deliver international orders?
A: Typically 3–6 weeks, depending on country regulations.

Q17: Can these tablets be sold in Europe?
A: Yes, with EU-GMP compliance, they can be registered.

Q18: Does Taj Pharma offer bulk API supply?
A: Yes, both formulations and APIs are available.

Q19: Are dossiers available for registration?
A: Yes, Taj Pharma provides CTD dossiers for regulated markets.

Q20: Why choose Taj Pharma?
A: Quality, affordability, global presence, and WHO-GMP certified excellence.