Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+5mg+12.5mg)

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+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 (40mg+5mg+12.5mg)

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+5mg+12.5mg) are a triple-combination antihypertensive medication used to effectively control high blood pressure (hypertension) in patients not adequately managed by monotherapy or dual therapy.

• Olmesartan Medoxomil: An angiotensin II receptor blocker (ARB) that prevents blood vessel constriction.

• Amlodipine: A calcium channel blocker (CCB) that relaxes blood vessels and improves blood flow.

• Hydrochlorothiazide: A thiazide diuretic that helps remove excess water and salt through urine, reducing blood volume and pressure.

By combining these three proven mechanisms, this fixed-dose formulation significantly reduces the risk of stroke, heart attack, and kidney damage, offering comprehensive cardiovascular protection.

The demand for Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+5mg+12.5mg) is growing globally, especially in Latin America, Africa, Southeast Asia, and the Middle East, where hypertension prevalence is rising. As a result, global buyers and importers are looking for trusted Indian manufacturers with WHO-GMP certification, regulatory support, and high-quality assurance — and Taj Pharma leads this space.

 A Trusted Manufacturer from India

Taj Pharma Ltd, headquartered in Mumbai with world-class facilities in Vapi, Gujarat, is a WHO-GMP, EU-GMP-certified manufacturer, exporter, and supplier of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+5mg+12.5mg).

Taj Pharma’s dedication to quality, innovation, and regulatory compliance makes it one of the most reliable names in the global pharmaceutical export market. With a strong presence across 70+ countries, Taj Pharma provides cost-effective and globally accepted formulations that meet international pharmacopoeial standards.

In-depth Details for Importers, Exporters, and Buyers

1. Regulatory Documentation & Compliance

Taj Pharma ensures seamless market entry with comprehensive documentation support:

• WHO-GMP, EU-GMP, and ISO certifications

• COPP (Certificate of Pharmaceutical Product)

• CTD / ACTD Dossier (Soft & Hard Copy)

• Product Registration Dossier support

• Bioequivalence & Stability data available on request

All documentation complies with Stringent International Regulatory Authorities (SRA) including FDA, EMA, TGA, and MHRA guidelines where applicable.

2. Packaging, Labeling, and Customization

Taj Pharma provides customized packaging solutions based on client market needs:

• Blister packs / Alu-Alu / PVC options

• Private label and custom branding available

• Multilingual labeling as per importing country’s language

• Tamper-proof and moisture-resistant packaging to ensure shelf stability

3. Shelf-life, Storage, and Dosage Form

• Dosage form: Film-coated tablets

• Strength: 40mg Olmesartan Medoxomil + 5mg Amlodipine + 12.5mg Hydrochlorothiazide

• Packaging: 10×10 tablets / customized export pack

• Shelf life: 24–36 months from the date of manufacture

• Storage: Store below 30°C in a dry, dark place

4. Export Certifications

Taj Pharma holds multiple international certifications, ensuring global acceptance:

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

• EU-GMP (European Union)

• ISO 9001:2015

• FDA (India) approved facility

• COPP, Free Sale Certificate, COA (Certificate of Analysis)

• DMF (Drug Master File) Support

These accreditations make Taj Pharma a preferred choice for pharmaceutical tenders, government supplies, and private label contracts across continents.

5. Target Export Markets

Taj Pharma exports Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+5mg+12.5mg) to major international markets:

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

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

• CIS Countries: Uzbekistan, Kazakhstan, Armenia, Georgia

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

• Latin America: Peru, Chile, Ecuador, Bolivia

Why Taj Pharma is the Most Trusted Manufacturer and Exporter

1. Advanced Manufacturing Infrastructure

Taj Pharma’s state-of-the-art facility in Vapi, Gujarat is equipped with modern technology, cleanroom environments, and automated production lines. All processes follow Good Manufacturing Practices (GMP), ensuring product consistency and purity.

2. Strict Quality Assurance

From raw material sourcing to final packaging, every batch undergoes multi-level quality checks under expert supervision. The in-house analytical labs use HPLC, UV spectrophotometry, and dissolution testers for precise validation.

3. Competitive & Affordable Pricing

Taj Pharma offers value-based pricing without compromising on quality, making it a preferred supplier for governments, distributors, and healthcare institutions worldwide.

4. Global Presence & Supply Chain Excellence

With an extensive distribution network across Asia, Africa, and Latin America, Taj Pharma ensures timely deliveries, regulatory support, and long-term business partnerships with clients.

5. Top 20 Export Destinations

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

For importers, distributors, and global buyers seeking a reliable manufacturer of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+5mg+12.5mg) with international certifications and competitive prices,
📩 Contact Taj Pharma today!

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

Top 20 FAQs  

1. What is Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet used for?
It is used to treat hypertension and reduce the risk of cardiovascular events like stroke and heart attack.

2. How does this combination work?
It relaxes blood vessels, enhances blood flow, and removes excess water, effectively lowering blood pressure.

3. Who manufactures it in India?
Taj Pharma Ltd, a WHO-GMP-certified company in Vapi, Gujarat, is a leading manufacturer and exporter.

4. Is this medication available for export?
Yes, Taj Pharma exports it to more than 70 countries globally.

5. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO 9001:2015, and COPP.

6. What is the shelf life of the product?
24–36 months from the manufacturing date.

7. Can importers request private labeling?
Yes, Taj Pharma offers private label and contract manufacturing options.

8. Is the product registered in other countries?
Yes, it is registered in several African and Asian regulatory markets.

9. What is the dosage form?
Film-coated oral tablets.

10. What are the common side effects?
Dizziness, fatigue, headache, diarrhea, and mild swelling.

11. What packaging formats are available?
10×10 tablets, blister/Alu-Alu packs, or customized export packs.

12. What regulatory documents are provided?
COPP, CTD dossier, COA, stability data, GMP certificate, and Free Sale Certificate.

13. What is the target market for this product?
Asia, Africa, CIS, and Latin America.

14. Is this product suitable for tender supply?
Yes, it is approved for government and NGO tender participation.

15. How can distributors order bulk quantities?
Orders can be placed directly through www.tajpharma.com or via official email.

16. What is the minimum order quantity (MOQ)?
MOQ varies by market—typically 10,000 tablets per order.

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

18. What languages are available for labeling?
English, French, Arabic, and Spanish (customizable).

19. Is the product bioequivalent to branded versions?
Yes, it complies with international pharmacokinetic standards.

20. Why choose Taj Pharma?
Because of its global reliability, WHO-GMP compliance, regulatory excellence, and customer-focused export services.