Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+5mg+12.5mg)

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+5mg+12.5mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+ 5mg+12.5mg)
2. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 5mg+12.5mg)
3. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+10mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+ 5mg+12.5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP……….20mg
Amlodipine Besilate USP               6.94mg
Equivalent to Amlodipine……………5mg
Hydrochlorothiazide USP…………….12.5mg
Excipients……………………………………q.s
Color: Sunset yellow FCF

2. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 5mg+12.5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP…………40mg
Amlodipine Besilate USP               6.94mg
Equivalent to Amlodipine………………5mg
Hydrochlorothiazide USP………………12.5mg
Excipients………………………………………q.s
Color: Brilliant blue FCF

3. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 10mg+25mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP…………40mg
Amlodipine Besilate USP               6.94mg
Equivalent to Amlodipine………………10mg
Hydrochlorothiazide USP……………….25mg
Excipients………………………………………q.s
Color: Orange G

THERAPEUTIC INDICATIONS:

Olmesartan, amlodipine, and hydrochlorothiazide is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly.

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 container with a child-resistant closure.
It is dangerous to take this preparation except under Medical supervision.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

When pregnancy is detected, Olmesartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimester of pregnancy.

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: Understanding Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+5mg+12.5mg)

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+5mg+12.5mg) is a triple-combination therapy widely prescribed for the treatment of high blood pressure (hypertension). It provides an effective and convenient approach to blood pressure management, particularly in patients where monotherapy or dual therapy is insufficient.

This formulation contains:

• Olmesartan Medoxomil (20mg) – an angiotensin II receptor blocker (ARB) that relaxes blood vessels by blocking the action of a natural substance that tightens them.

• Amlodipine (5mg) – a calcium channel blocker (CCB) that enhances blood flow and prevents vessel constriction.

• Hydrochlorothiazide (12.5mg) – a thiazide diuretic that helps the body remove excess water and sodium, reducing overall blood volume and pressure.

This synergistic combination helps lower systolic and diastolic blood pressure, reducing the risk of stroke, heart attack, and kidney complications associated with hypertension. The medication is available by prescription and is particularly effective for long-term hypertension management.

Globally, hypertension affects nearly 1.3 billion adults, driving the demand for safe and affordable combination therapies like Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets. Indian manufacturers, led by Taj Pharma, have become preferred suppliers for international buyers seeking reliable WHO-GMP compliant production with guaranteed quality and regulatory support.

 India’s Leading Manufacturer and Exporter

Taj Pharma Ltd, headquartered in Mumbai with advanced manufacturing facilities in Vapi, Gujarat, is a well-known manufacturer, supplier, and exporter of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+5mg+12.5mg).

Taj Pharma stands among India’s top WHO-GMP and ISO-certified pharmaceutical companies, producing globally accepted formulations under strict international quality standards. Every batch undergoes multi-layered quality control, ensuring purity, stability, and efficacy that meet the needs of patients worldwide.

With a strong reputation across 70+ countries, Taj Pharma has established itself as a trusted partner for global importers, distributors, and PCD franchise holders seeking high-quality cardiovascular formulations.

In-Depth Details for Importers, Exporters, and Buyers

1. Regulatory Documentation Provided

Taj Pharma ensures complete export readiness with robust regulatory documentation support. The following documents are available to facilitate market registration and approval:

• WHO-GMP Certificate

• EU-GMP and ISO 9001:2015 Certification

• COPP (Certificate of Pharmaceutical Product)

• CTD / ACTD Dossier in soft and hard copy

• Stability data (zone-wise available)

• Certificate of Analysis (COA)

• Free Sale Certificate and COA

• Bioequivalence Data (on request)

All products are manufactured under strict Good Manufacturing Practices (GMP), ensuring full compliance with global health authorities such as WHO, EMA, and FDA guidelines.

2. Custom Packaging & Labeling

Taj Pharma provides flexible packaging and labeling solutions to meet client-specific requirements:

• Packaging Options: Blister, Alu-Alu, PVC, or bottle packaging

• Pack Size: Standard 10×10 tablets / customized as per export requirement

• Private Label Manufacturing: Available for global pharmaceutical distributors

• Multilingual Labels: English, French, Arabic, or any preferred language

• Tamper-proof Sealing: Ensuring stability during transportation

All packaging complies with pharmacopoeial standards (BP, USP, IP) for enhanced shelf-life and international acceptability.

3. Shelf-life, Storage, and Dosage Form

• Dosage Form: Film-coated tablet

• Composition: Olmesartan Medoxomil 20mg + Amlodipine 5mg + Hydrochlorothiazide 12.5mg

• Shelf Life: 24 to 36 months from the date of manufacture

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

• Therapeutic Class: Antihypertensive / Cardiovascular

4. Export Certifications

Taj Pharma maintains globally recognized certifications that demonstrate its quality and compliance excellence:

• WHO-GMP & EU-GMP Certification

• ISO 9001:2015

• COPP (Certificate of Pharmaceutical Product)

• FDA (India) Approved Manufacturing Unit

• COA, FSC, COA with Batch Analysis Reports

• DMF (Drug Master File) Support

These certifications make Taj Pharma the preferred choice for government tenders, NGO procurements, and private label exports across continents.

5. Target Countries & Export Markets

Taj Pharma’s Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+5mg+12.5mg) are exported to over 70 countries across multiple continents:

• Africa: Nigeria, Kenya, Ghana, South Africa, Uganda, Tanzania

• Asia-Pacific: Vietnam, Sri Lanka, Myanmar, Philippines, Cambodia

• CIS Countries: Uzbekistan, Armenia, Kazakhstan, Georgia

• Latin America: Peru, Bolivia, Ecuador, Chile

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

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

1. State-of-the-Art Manufacturing

Taj Pharma’s production facility in Vapi, Gujarat adheres to WHO-GMP and PIC/S standards, featuring fully automated production lines, cleanroom environments, and advanced quality control labs. All equipment is validated for sterility and precision manufacturing.

2. Affordable Pricing & Quality Assurance

With a vertically integrated supply chain and efficient manufacturing processes, Taj Pharma delivers cost-effective yet high-quality formulations, enabling global buyers to remain competitive in their markets without compromising quality.

3. Global Presence & Regulatory Expertise

Taj Pharma has a global presence across Asia, Africa, CIS, Latin America, and the Middle East, offering complete regulatory support, timely product registration, and end-to-end logistics management for seamless export operations.

4. Top 20 Exporting Countries

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

Call to Action  

If you are a pharmaceutical importer, distributor, or PCD franchise owner seeking a reliable manufacturer and exporter of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+5mg+12.5mg) — Taj Pharma is your best choice.

With WHO-GMP-certified facilities, proven regulatory expertise, and competitive global pricing, Taj Pharma ensures you get the highest quality formulations with full compliance and documentation support.

📞 Contact Taj Pharma Today:
Email: info@tajpharma.com
Website: www.tajpharma.com
Address: Taj Pharma Ltd., Plot No. 15/16, GIDC, Vapi, Gujarat, India

Top 20 FAQs 

1. What is Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet used for?
It is prescribed to treat high blood pressure when single or dual medications are not effective.

2. How does this medicine work?
It combines three mechanisms: relaxing blood vessels, enhancing blood flow, and removing excess salt and water to lower blood pressure.

3. Who is the top manufacturer in India?
Taj Pharma Ltd, based in Vapi, Gujarat, is a leading WHO-GMP certified manufacturer and exporter.

4. What is the dosage form?
Film-coated oral tablets for once-daily administration.

5. Is it available for export?
Yes. Taj Pharma exports this product to over 70 international markets.

6. What certifications support export?
WHO-GMP, EU-GMP, ISO, COPP, and Free Sale Certificates are available.

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

8. Does Taj Pharma offer private labeling?
Yes, private label manufacturing and custom branding are available.

9. Are multilingual labels supported?
Yes, labeling can be done in English, French, Arabic, Spanish, and other languages.

10. Is WHO-GMP certification mandatory for export?
Yes, and Taj Pharma meets all WHO-GMP and EU-GMP quality standards.

11. What is the MOQ for export orders?
Typically 10,000 tablets or as per the importing country’s regulation.

12. What are the possible side effects?
Dizziness, nausea, fatigue, diarrhea, or mild swelling — all generally mild and transient.

13. Can this product be registered for tenders?
Yes, Taj Pharma supports registration and documentation for global tenders.

14. What therapeutic class does this belong to?
It belongs to the antihypertensive drug class.

15. What packaging formats are offered?
Blister, Alu-Alu, PVC, or custom packaging based on market needs.

16. What regions are targeted for export?
Africa, CIS, Asia-Pacific, Latin America, and the Middle East.

17. What is Taj Pharma’s manufacturing location?
Vapi, Gujarat, India — an industrial hub for WHO-GMP pharmaceutical production.

18. Does Taj Pharma offer regulatory submission support?
Yes, complete CTD dossiers and COPP documentation are provided.

19. Is it cost-effective compared to branded versions?
Yes, Taj Pharma offers globally competitive pricing with equivalent therapeutic efficacy.

20. Why choose Taj Pharma?
For its quality commitment, regulatory reliability, and global export excellence.