Amlodipine and Valsartan Tablets 5mg+160mg

Amlodipine and Valsartan Tablets  5mg+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 5mg+160mg

Amlodipine and Valsartan Tablets 5mg+160mg are widely prescribed for the management of Hypertension (high blood pressure). This fixed-dose combination ensures effective blood pressure control by using two complementary mechanisms:

• Amlodipine (5mg): A calcium channel blocker (CCB) that relaxes blood vessels, reducing vascular resistance.

• Valsartan (160mg): An angiotensin II receptor blocker (ARB) that prevents narrowing of arteries, lowering the strain on the heart.

This dual therapy offers better control than monotherapy, reduces cardiovascular risks, and enhances patient compliance with a single daily dose.

With over 1.2 billion people worldwide affected by hypertension, the demand for Amlodipine and Valsartan Tablets 5mg+160mg is expanding rapidly in both regulated and semi-regulated markets. India, particularly Taj Pharma, is a leading supplier meeting this demand globally.

In-Depth Details for Importers, Exporters, and Buyers

Taj Pharma ensures that every batch of Amlodipine and Valsartan Tablets 5mg+160mg complies with global regulatory frameworks, making it an ideal partner for international buyers.

📑 Regulatory Documentation Provided

• WHO-GMP Certificate

• EU-GMP certification (for regulated markets)

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• CTD/ACTD dossiers for regulatory submissions

• Free Sale Certificate (FSC)

• Batch Manufacturing Records and Stability Data

📦 Custom Packaging & Labeling

• Blister packs, bottles, and bulk packaging available

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

• Tamper-proof export-grade cartons

• Private labeling support for PCD Pharma Franchise partners

📋 Shelf-Life, Storage & Dosage Form

• Dosage Form: Oral tablets

• Strength: Amlodipine 5mg + Valsartan 160mg

• Shelf-life: 24–36 months

• Storage: Store below 30°C, protected from moisture and light

🌍 Export Certifications

• WHO-GMP & ISO 9001:2015 certified plants

• EU-GMP (where applicable)

• COPP available for semi-regulated markets

• CTD/ACTD dossiers for fast approvals

• DMF support available on request

🌐 Target Countries & Export Markets

Taj Pharma exports Amlodipine and Valsartan Tablets 5mg+160mg to:

• Asia: Vietnam, Philippines, Sri Lanka, Nepal

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

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

• Latin America: Peru, Chile, Bolivia, Ecuador

• CIS & Eastern Europe: Ukraine, Kazakhstan, Uzbekistan

Why is the Most Trusted Manufacturer, Supplier & Exporter

Taj Pharma, based in Vapi, Gujarat, India, is recognized globally for its world-class pharmaceutical manufacturing and export capabilities.

🏭 State-of-the-Art Manufacturing

• WHO-GMP & EU-GMP certified facilities

• Fully automated production systems

• Strict compliance with USP, BP, and IP standards

💰 Affordable Pricing & Quality Assurance

• Competitive pricing to ensure accessibility

• In-house laboratories with stringent quality checks

• Stability-tested formulations ensuring efficacy till expiry

🌐 Global Presence & Supply Chain Support

• Exporting to 40+ countries worldwide

• Seamless logistics and documentation support

• Long-term collaborations with distributors, governments, and hospitals

🌍 Top 20 Countries Exporting Amlodipine and Valsartan Tablets 5mg+160mg

1. India (domestic supply PAN India)

2. Vietnam

3. Philippines

4. Sri Lanka

5. Bangladesh

6. Kenya

7. Nigeria

8. Ghana

9. South Africa

10. Ethiopia

11. UAE

12. Iraq

13. Saudi Arabia

14. Oman

15. Peru

16. Chile

17. Bolivia

18. Ecuador

19. Ukraine

20. Kazakhstan

Technical Product Specification Table

Call to Action for Buyers & Distributors

Are you searching for a reliable Amlodipine and Valsartan Tablets 5mg+160mg manufacturer in India? Taj Pharma offers quality, affordability, and global compliance all under one roof.

📩 Get in touch today for bulk supply, regulatory support, or PCD Pharma Franchise opportunities.

🌐 Website: www.tajpharma.com
📧 Email: info@tajpharma.com

Top 20 FAQs

1. What are Amlodipine and Valsartan Tablets 5mg+160mg used for?
They are used to manage high blood pressure and reduce cardiovascular risks.

2. Who manufactures them in India?
Taj Pharma is a leading WHO-GMP certified manufacturer and exporter.

3. How do they work?
Amlodipine relaxes blood vessels while Valsartan prevents narrowing, ensuring effective pressure control.

4. Are these WHO-GMP certified?
Yes, Taj Pharma’s facilities meet WHO-GMP and ISO standards.

5. What is the shelf life?
24–36 months under recommended storage conditions.

6. Can they be taken with food?
Yes, they can be taken with or without food.

7. Common side effects?
Dizziness, swelling (edema), nasopharyngitis, and respiratory infections.

8. Export availability?
Yes, exported to 40+ countries globally.

9. Are they prescription-only?
Yes, they should be prescribed by a healthcare provider.

10. Which pharmacopeias are followed?
USP, BP, IP standards based on buyer requirements.

11. Are custom packs available?
Yes, Taj Pharma provides tailored packaging and private labeling.

12. What regulatory support is provided?
COPP, COA, CTD dossiers, and stability data are shared.

13. Is this combination better than monotherapy?
Yes, it offers superior control of blood pressure than either drug alone.

14. Can distributors request samples?
Yes, samples are provided for quality verification.

15. Does Taj Pharma support government tenders?
Yes, they supply to hospitals and government health programs.

16. Are bulk orders supported?
Yes, Taj Pharma specializes in large-scale supply chains.

17. Does Taj Pharma offer franchise opportunities?
Yes, PCD Pharma Franchise PAN India is available.

18. What strength variations are available?
Other strengths like 5mg+320mg and 10mg+320mg are also produced.

19. What storage conditions are required?
Store in a cool, dry place below 30°C.

20. Why choose Taj Pharma?
Because Taj Pharma combines quality, affordability, regulatory expertise, and global trust.