Ropinirole Extended-Release Tablets 4mg

Ropinirole Extended-Release Tablets  4mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Ropinirole Extended-Release Tablets USP 1mg
B) Ropinirole Extended-Release Tablets USP 2mg
C) Ropinirole Extended-Release Tablets USP 4mg
D) Ropinirole Extended-Release Tablets USP 6mg
E) Ropinirole Extended-Release Tablets USP 8mg
F) Ropinirole Extended-Release Tablets USP 12mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ropinirole Extended-Release Tablets USP 1mg
Each extended-Release film coated tablet contains:
Ropinirole Hydrochloride USP
Equivalent to Ropinirole………….1mg
Excipients…………………………………q.s.
Colours: Quinizarine green ss

B) Ropinirole Extended-Release Tablets USP 2mg
Each extended-Release film coated tablet contains:
Ropinirole Hydrochloride USP
Equivalent to Ropinirole………….2mg
Excipients…………………………………q.s.
Colours: Red oxide of iron

C) Ropinirole Extended-Release Tablets USP 4mg
Each extended-Release film coated tablet contains:
Ropinirole Hydrochloride USP
Equivalent to Ropinirole………….4mg
Excipients…………………………………q.s.
Colours: Ponceau 4 R

D) Ropinirole Extended-Release Tablets USP 6mg
Each extended-Release film coated tablet contains:
Ropinirole Hydrochloride USP
Equivalent to Ropinirole………….6mg
Excipients…………………………………q.s.
Colours: Titanium dioxide

E) Ropinirole Extended-Release Tablets USP 8mg
Each extended-Release film coated tablet contains:
Ropinirole Hydrochloride USP
Equivalent to Ropinirole………….8mg
Excipients…………………………………q.s.
Colours: Brilliant blue lake

F) Ropinirole Extended-Release Tablets USP 12mg
Each extended-Release film coated tablet contains:
Ropinirole Hydrochloride USP
Equivalent to Ropinirole………….12mg
Excipients…………………………………q.s.
Colours: Pigment yellow 3

THERAPEUTIC INDICATIONS:

Ropinirole is used alone or with other medications to treat Parkinson’s disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness.

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.

Attach dispensing label as per end country..

Introduction to Ropinirole Extended-Release Tablets 4mg

Ropinirole Extended-Release Tablets 4mg are an essential medication in the treatment of Parkinson’s disease and Restless Leg Syndrome (RLS). As a non-ergot dopamine agonist, ropinirole works by directly stimulating dopamine receptors in the brain, thereby improving symptoms such as tremors, stiffness, muscle spasms, slowed movements, and poor muscle control.

Unlike immediate-release versions, Ropinirole Extended-Release Tablets 4mg are designed for once-daily dosing, providing continuous therapeutic effects over a 24-hour period. This enhances patient compliance, reduces symptom fluctuations, and improves the overall quality of life.

With the increasing prevalence of neurological disorders worldwide, the demand for Ropinirole Extended-Release Tablets 4mg is growing rapidly. India has become a major hub for manufacturing and exporting affordable, high-quality generics, and Taj Pharma leads the way as the most trusted Ropinirole Extended-Release Tablets 4mg manufacturer in India.

In-depth Details for Importers, Exporters, and Buyers

✅ Regulatory Documentation Provided

Taj Pharma ensures complete regulatory compliance, making global trade seamless. Documentation includes:

• WHO-GMP Certificate

• COPP (Certificate of Pharmaceutical Product)

• ISO 9001:2015 certification

• Certificate of Analysis (CoA) with every batch

• Stability Data (accelerated & real-time)

• CTD/ACTD Dossiers for international registration

• Free Sale Certificate for multiple export markets

✅ Custom Packaging & Labeling

Taj Pharma provides packaging solutions tailored to market-specific needs:

• Alu-Alu Blister packs

• PVC Blister packs

• HDPE bottles (bulk or hospital packs)

• Private labeling & branding for global distributors

✅ Shelf-life, Storage & Dosage Form

• Dosage Form: Extended-Release Tablets

• Strength: 4mg

• Shelf-life: 24–36 months

• Storage: Store below 25°C in a cool, dry place, away from light and moisture

✅ Export Certifications

Taj Pharma is accredited with multiple international certifications:

• WHO-GMP approved facilities

• EU-GMP certifications (selected plants)

• FDA (India) approval

• ISO-certified quality systems

• Global regulatory dossiers (CTD/ACTD)

✅ Target Countries & Export Markets

Taj Pharma has a strong footprint in more than 85 countries, making it a reliable partner for global buyers. Key markets include:

• Asia: Vietnam, Philippines, Myanmar, Sri Lanka

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

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

• CIS Countries: Uzbekistan, Kazakhstan, Georgia

• Latin America: Peru, Ecuador, Bolivia

• Eastern Europe: Ukraine, Belarus

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

1. State-of-the-Art Manufacturing Facilities

Taj Pharma operates cutting-edge plants in Vapi, Gujarat, adhering to WHO-GMP, EU-GMP, and ISO standards. Strict quality checks are performed at every stage—API sourcing, formulation, packaging, and dispatch.

2. Affordable Pricing with Assured Purity

As a leading generic medicine manufacturer, Taj Pharma offers cost-effective yet high-quality formulations, making Ropinirole Extended-Release Tablets 4mg export from India accessible to both developed and emerging markets.

3. Strong Global Supply Chain

With a presence in 85+ countries, Taj Pharma ensures timely delivery, customized packaging, and regulatory support, enabling smooth business for distributors and importers.

4. Top 20 Export Destinations for Ropinirole Extended-Release Tablets 4mg

1. Vietnam

2. Kenya

3. Nigeria

4. UAE

5. Iraq

6. Saudi Arabia

7. Myanmar

8. Sri Lanka

9. Uzbekistan

10. Ghana

11. South Africa

12. Oman

13. Tanzania

14. Philippines

15. Peru

16. Ecuador

17. Georgia

18. Kazakhstan

19. Bolivia

20. Yemen

Technical Product Specification

Call to Action for Buyers and Distributors

Are you searching for a trusted Ropinirole Extended-Release Tablets 4mg manufacturer in India?

👉 Partner with Taj Pharma, a globally recognized WHO-GMP certified manufacturer and exporter.

We provide:

• Bulk supply & contract manufacturing

• PCD Pharma Franchise opportunities

• Custom branding & private labeling

• Affordable pricing for global buyers

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

Top 20 FAQs on Ropinirole Extended-Release Tablets 4mg

1. What is Ropinirole Extended-Release Tablets 4mg used for?
It is used to treat Parkinson’s disease and Restless Leg Syndrome (RLS).

2. How does it work?
It stimulates dopamine receptors, improving movement and muscle control.

3. How should it be taken?
Once daily, preferably at the same time each day.

4. How long does it take to work?
About 1.5 to 2 hours after intake.

5. Can it be taken with levodopa?
Yes, as monotherapy or in combination with levodopa.

6. What are the side effects?
Dizziness, fatigue, nausea, heartburn, anxiety, and twitching.

7. What is the shelf-life?
24–36 months.

8. How long does it stay in the system?
About 24–36 hours.

9. Is it safe long term?
Yes, when prescribed and monitored by a physician.

10. Is Taj Pharma WHO-GMP certified?
Yes, all plants are WHO-GMP and ISO compliant.

11. Does Taj Pharma provide export dossiers?
Yes, CTD/ACTD dossiers are available.

12. What packaging is available?
Blister packs, HDPE bottles, and custom export packaging.

13. Can buyers opt for private labeling?
Yes, Taj Pharma offers private branding support.

14. Which countries import this medicine?
Kenya, UAE, Nigeria, Vietnam, Peru, and others.

15. Does Taj Pharma provide PCD Pharma Franchise?
Yes, across PAN India.

16. Is it cost-effective compared to global brands?
Yes, Taj Pharma provides highly competitive prices.

17. What certifications does Taj Pharma have?
WHO-GMP, EU-GMP, ISO, CoA, and more.

18. Is bulk supply available?
Yes, institutional and wholesale bulk orders are supported.

19. How is quality tested?
Through stability studies, HPLC, GC, and strict QA protocols.

20. Why choose Taj Pharma?
For its affordability, compliance, purity, and strong global presence.