Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg

Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Irbesartan & Hydrochlorothiazide Tablets USP 150mg+12.5mg
B) Irbesartan & Hydrochlorothiazide Tablets USP 300mg+12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Irbesartan & Hydrochlorothiazide Tablets USP 150mg+12.5mg
Each film coated tablet contains:
Irbesartan USP…………………………150mg
Hydrochlorothiazide USP………….12.5mg
Excipients………………………………….q.s
Colour: Red Oxide of Iron

B) Irbesartan & Hydrochlorothiazide Tablets USP 300mg+12.5mg
Each film coated tablet contains:
Irbesartan USP…………………………300mg
Hydrochlorothiazide USP………….12.5mg
Excipients………………………………….q.s
Colour: Lake of Erythrosine

THERAPEUTIC INDICATIONS:

This drug is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains two medications: irbesartan and hydrochlorothiazide. Irbesartan is an angiotensin receptor blocker (ARB) and works by relaxing blood vessels so that blood can flow more easily. Hydrochlorothiazide is a “water pill” (diuretic) that causes you to make more urine, which helps your body get rid of extra salt and water.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

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) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician

Introduction to Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg

Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg are a combination antihypertensive medication widely prescribed to manage high blood pressure (hypertension). The combination brings together two powerful agents:

• Irbesartan (300mg): An angiotensin II receptor blocker (ARB) that relaxes blood vessels, improving blood flow and reducing blood pressure.

• Hydrochlorothiazide (12.5mg): A thiazide diuretic (“water pill”) that helps eliminate excess salt and water through urine, reducing fluid retention and supporting better blood pressure control.

By working synergistically, this combination helps reduce strain on the heart and arteries, significantly lowering risks of stroke, kidney damage, and cardiovascular complications.

The global demand for this medicine is rising due to the alarming prevalence of hypertension. According to the WHO, more than 1.28 billion adults worldwide suffer from high blood pressure, making antihypertensive drugs one of the fastest-growing therapeutic segments.

This growing need creates vast opportunities for Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg manufacturers in India to cater to both domestic and international markets.

Regulatory & Export Support for Importers/Buyers

Taj Pharma understands the complexity of pharmaceutical imports. As a trusted Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg exporter from India, we provide comprehensive regulatory and export documentation to ease global trade.

1. Regulatory Documentation Provided:

• WHO-GMP Certificate

• EU-GMP compliance support

• Certificate of Pharmaceutical Product (CoPP)

• Drug Master File (DMF) & CTD/eCTD dossiers

• Free Sale Certificate

• Stability Data (Zone IVa/IVb)

• Bioequivalence (BE) data, if required

2. Packaging & Labeling Options:

• Custom branding for distributors & PCD franchise partners

• Blister packs / Alu-Alu / Strip packs

• Bulk packaging for institutional supply

• Labeling compliant with importing country regulations

3. Shelf-life & Storage:

• Standard shelf-life: 24–36 months

• Storage: Below 30°C, protected from light & moisture

4. Dosage Form:

• Film-coated tablets: 300mg+12.5mg combination

• Available in 10×10 blister/Alu-Alu packs

5. Export Certifications:

Taj Pharma complies with stringent international quality norms:

• WHO-GMP certified

• EU-GMP & PIC/S support

• ISO 9001:2015 & ISO 14001 certified

• USFDA & MHRA audit-ready facilities

6. Target Export Markets:

Our export footprint extends to 40+ countries, including:

• Asia-Pacific: Vietnam, Philippines, Sri Lanka, Bangladesh

• Africa: Kenya, Nigeria, South Africa, Ghana

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

• CIS & Eastern Europe: Russia, Ukraine, Kazakhstan

• Latin America: Peru, Chile, Brazil, Mexico

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

Taj Pharma stands as a leader in Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg manufacturing in India due to its quality-first philosophy and unmatched supply chain reliability.

1. State-of-the-Art Manufacturing

• Located in Vapi, Gujarat, with fully automated WHO-GMP/EU-GMP plants.

• Dedicated antihypertensive formulation units with strict segregation.

• In-house R&D for formulation stability, BE studies, and continuous innovation.

2. Affordable Pricing & Quality Assurance

• Competitive pricing structure for global buyers.

• Rigorous quality control (QC) checks at every stage: raw material, in-process, and final product.

• International pharmacopoeia compliance: USP, BP, IP, Ph. Eur.

3. Global Presence & Supply Chain Support

• 20+ years in exports to regulated & semi-regulated markets.

• Robust logistics network with temperature-controlled shipping.

• End-to-end documentation support for hassle-free registration.

4. Top 20 Export Countries of Taj Pharma

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specifications

Side Effects of Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg

Like all medicines, this combination may cause some side effects:

• Dizziness or lightheadedness

• Headaches

• Nausea or vomiting

• Diarrhea

• Muscle or joint pain

• Rare: blurred vision, bleeding gums, tarry stools, or skin rashes

Note: Most side effects are temporary. Seek medical attention if serious symptoms occur.

PCD Pharma Franchise Opportunities with Taj Pharma

Taj Pharma offers Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg PCD Pharma Franchise opportunities across India.

• Monopoly-based distribution rights

• Marketing & promotional support

• Attractive margins for distributors

• PAN-India supply chain

Top 20 FAQs 

1. What are Irbesartan & Hydrochlorothiazide Tablets used for?
They treat high blood pressure (hypertension) and reduce risks of heart disease and stroke.

2. Who manufactures Irbesartan & Hydrochlorothiazide Tablets 300mg+12.5mg in India?
Taj Pharma is a leading WHO-GMP-certified manufacturer in Vapi, Gujarat, India.

3. Can I import Irbesartan & Hydrochlorothiazide Tablets from India?
Yes. Taj Pharma provides all export certifications and dossiers for global registrations.

4. What is the standard packaging?
Available in 10×10 blister or Alu-Alu packs, customized as per buyer needs.

5. What is the shelf life of this medicine?
Typically 24–36 months under proper storage.

6. Is it safe during pregnancy?
No, it is contraindicated in pregnancy. Consult a physician.

7. Can it be taken with food?
Yes, it can be taken with or without food, preferably at the same time daily.

8. Are there generic versions available?
Yes, Taj Pharma supplies cost-effective generic formulations.

9. What certifications does Taj Pharma have?
WHO-GMP, EU-GMP, ISO, CoPP, and regulatory dossiers.

10. Does Taj Pharma offer PCD Pharma Franchise?
Yes, PAN-India PCD opportunities are available.

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

12. Can it cause dizziness?
Yes, initial doses may cause dizziness. Doctors may advise taking it at bedtime.

13. Is weight gain a side effect?
No, weight gain was not reported in clinical studies.

14. What should be avoided while on this medication?
Avoid alcohol and potassium-rich salt substitutes unless prescribed.

15. Can it be exported to Africa?
Yes, Taj Pharma exports to Kenya, Nigeria, Ghana, South Africa, and more.

16. How soon does it start working?
Within a few hours, with maximum benefit in 2–4 weeks.

17. Is it available in bulk packaging?
Yes, for hospitals, institutions, and tender supply.

18. Does Taj Pharma offer bioequivalence data?
Yes, on request, for regulatory submissions.

19. Can Irbesartan & Hydrochlorothiazide Tablets be combined with other antihypertensives?
Yes, under medical supervision.

20. How do I place a bulk order with Taj Pharma?
Contact Taj Pharma’s export division at Taj Pharma Official Website.