Tamsulosin Hydrochloride MR + Dutasteride Tablet (0.4mg+0.5mg)

Tamsulosin Hydrochloride MR + Dutasteride Tablet (0.4mg+0.5mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Tamsulosin Hydrochloride MR+ Dutasteride Tablet 0.4mg+0.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Tamsulosin Hydrochloride MR+ Dutasteride Tablet 0.4mg+0.5mg
  Each Film-coated tablet contains:
  Tamsulosin Hydrochloride I.P.…………..0.4mg
  (As modified release)
  Dutasteride I.P……………………………0.5mg
  Excipients…………………………………. q.s
  Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Dutasteride and tamsulosin combination is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. </br>

CAUTION & WARNING:

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

Exposure of women-Risk fetus: Dutasteride present in this tablet is absorbed through the skin. Therefore, women who are pregnant or may be pregnant should not handle crushed or broken tablets of alfusin-D because of the possibility of absorption of the medicine and the potential risk of a foetal anomaly to a male foetus.

SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.
Do not freeze.
Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

Introduction to Tamsulosin Hydrochloride MR + Dutasteride Tablet (0.4mg+0.5mg)

This fixed-dose combination includes:

• Tamsulosin Hydrochloride MR (0.4mg) – An alpha-blocker that relaxes bladder neck and prostate muscles, improving urine flow.

• Dutasteride (0.5mg) – A 5-alpha reductase inhibitor that reduces prostate size by lowering DHT levels.

Key Medical Uses

• Treatment of Benign Prostatic Hyperplasia (BPH)

• Reduction of prostate gland size

• Relief from urinary symptoms such as:

  • Weak urine stream

  • Frequent urination

  • Nocturia

  • Incomplete bladder emptying

Global Market Demand

The global BPH treatment market is projected to grow significantly due to:

• Increasing ageing population

• Rising healthcare awareness

• Growing demand for combination therapy

• Higher adoption of cost-effective generics from India

This positions India—and specifically Taj Pharma—as a crucial supplier for international pharmaceutical buyers.

Comprehensive Information for Importers, Distributors & Global Buyers

Regulatory Documentation by Taj Pharma

Taj Pharma provides complete export-compliant documentation including:

• WHO-GMP Certificate

• EU-GMP support (where applicable)

• COPP (Certificate of Pharmaceutical Product)

• CTD/ACTD Dossier

• Free Sale Certificate (FSC)

• COA (Certificate of Analysis)

• MSDS (Material Safety Data Sheet)

• Stability Data (Accelerated & Real-Time)

• Batch Manufacturing Records (BMR & BPR)

This allows seamless registration in global markets.

 Custom Packaging & Private Labeling

Taj Pharma offers full flexibility:

• Alu-Alu / Blister packs

• Moisture-protective packaging

• Customized branding for private label buyers

• Regional language printing

• Barcoding (GS1 compliant)

• Serialized packaging support

 Shelf Life, Dosage Form & Storage

Export Certifications of Taj Pharma

Taj Pharma is certified by:

• WHO-GMP

• ISO 9001:2015

• ISO 14001

• GLP Certified

• FDA-Approved Manufacturing Sites

Export buyers benefit from regulatory-ready batches compliant with global quality standards.

 Target Export Markets

Taj Pharma exports Tamsulosin Hydrochloride MR + Dutasteride Tablet (0.4mg+0.5mg) to:

• Latin America

• CIS nations

• Middle East

• Southeast Asia

• Africa

• South Asia

• Central America

• European tender buyers (where permitted)

 Why Taj Pharma Is the Most Trusted Tamsulosin + Dutasteride Tablets Manufacturer & Exporter

  1. State-of-the-Art Manufacturing Infrastructure

• Advanced WHO-GMP compliant plant in Vapi, Gujarat

• Dedicated tablet compression lines

• Modern QC/QA laboratories

• Automated packaging & serialization

 2. Affordable Pricing With Guaranteed Purity

Taj Pharma is known for:

• Cost-effective bulk manufacturing

• High API purity

• Zero-contamination processes

• Excellent dissolution & stability results

  3. Strong Global Presence & Supply Chain Support

With exports to over 80+ countries, Taj Pharma guarantees:

• On-time shipment

• Assistance in product registration

• Fast document turnaround

• Sea/Air shipment support

 Top 20 Countries 

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

Technical Product Specification Table

Call to Action

If you are a global importer, government tender agency, distributor, or PCD pharma franchise seeker, Taj Pharma offers the most reliable, regulatory-compliant, and competitively priced supply of:

Tamsulosin Hydrochloride MR + Dutasteride Tablet (0.4mg+0.5mg)

📩 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📦 Request Free Samples, COA & Dossier Today

Top 20 FAQs 

1. What is Tamsulosin Hydrochloride MR + Dutasteride Tablet used for?

It is used to treat BPH symptoms and reduce prostate size.

2. Is Taj Pharma a WHO-GMP certified manufacturer?

Yes, Taj Pharma is fully WHO-GMP, ISO, and GLP certified.

3. What is the dosage strength?

0.4mg Tamsulosin MR + 0.5mg Dutasteride.

4. Can this product be exported internationally?

Yes, Taj Pharma exports to 80+ countries.

5. What packaging options are available?

Alu-Alu, blister, HDPE bottles, and custom private-label packaging.

6. Does Taj Pharma provide regulatory dossiers?

Yes, CTD/ACTD dossiers and COPP are supplied.

7. What is the shelf life?

Typically 24–36 months.

8. Is this combination safe for long-term use?

Yes, under medical supervision.

9. What are the common side effects?

Reduced libido, dizziness, ejaculation issues, breast tenderness.

10. When should it be taken?

About 30 minutes after the same meal daily.

11. Does it improve urine flow?

Yes, significantly.

12. Can it shrink the prostate?

Dutasteride helps reduce prostate size over time.

13. Are stability batches available?

Yes, real-time and accelerated stability reports can be provided.

14. Is private labeling allowed?

Yes, Taj Pharma offers OEM/contract manufacturing.

15. Do you provide samples for registration?

Yes, authorized buyers can request samples.

16. Does Taj Pharma manufacture API too?

Taj Pharma sources high-quality APIs from approved vendors.

17. Can buyers get customized pack designs?

Absolutely—full branding customization is supported.

18. What is the minimum export order?

Varies by region—typically 1–2 pallets.

19. How long does shipping take?

15–30 days, depending on region and documentation.

20. Why choose Taj Pharma?

For unmatched quality, regulatory compliance, and global reliability.