Ropinirole Extended-Release Tablet 2mg

Ropinirole Extended-Release Tablets  2mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Ropinirole Extended-Release Tablets USP 1mg
• Ropinirole Extended-Release Tablets USP 2mg
• Ropinirole Extended-Release Tablets USP 4mg
• Ropinirole Extended-Release Tablets USP 6mg
• Ropinirole Extended-Release Tablets USP 8mg
• Ropinirole Extended-Release Tablets USP 12mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• 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
• 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
• 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
• 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
• 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
• 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 & SHEDULE:

• CAUTION: Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
• SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

• Storage: Store below 30°C.Protect from Light and moisture.
• Dosage: As directed by the Physician

Introduction to Ropinirole Extended-Release Tablet 2mg

Ropinirole Extended-Release Tablet 2mg is a prescription medication classified as a dopamine agonist, primarily used for the management of Parkinson’s disease (PD) and Restless Legs Syndrome (RLS). It acts by stimulating dopamine receptors in the brain, helping to control movement-related symptoms such as tremors, stiffness, muscle spasms, and poor muscle control.

The extended-release (ER) formulation of Ropinirole offers 24-hour symptom control with once-daily dosing, significantly improving patient adherence and quality of life. The 2mg dosage often represents the initial or titration phase, helping patients adjust to the medication before moving to higher doses (4mg, 6mg, or 12mg).

Globally, there is a growing demand for Ropinirole Extended-Release Tablet 2mg due to the increasing prevalence of neurological disorders and the preference for sustained-release medications that provide steady plasma levels and fewer side effects.

In this growing pharmaceutical segment, Taj Pharma has established itself as a leading manufacturer, supplier, and exporter of Ropinirole Extended-Release Tablet 2mg from Vapi, Gujarat, India—delivering excellence in both quality and affordability.

Product Overview and Global Demand

Taj Pharma’s Ropinirole Extended-Release Tablet 2mg meets stringent international pharmacopoeial standards (IP/BP/USP) and is manufactured under WHO-GMP and ISO 9001:2015-certified facilities.

Ropinirole ER is often prescribed alone or alongside levodopa therapy to manage Parkinson’s disease effectively. The 2mg strength is crucial during the titration phase, allowing gradual adjustment while minimizing side effects like dizziness or nausea.

The increasing global prevalence of Parkinson’s disease, coupled with the demand for cost-effective generic formulations, has made India—especially Taj Pharma—a preferred source for bulk procurement and contract manufacturing of Ropinirole ER formulations.

 In-depth Details for Importers, Exporters, and Global Buyers

Regulatory Documentation Provided

Taj Pharma provides full regulatory support for Ropinirole Extended-Release Tablet 2mg, including:

• COA (Certificate of Analysis)

• WHO-GMP Certificate

• COPP (Certificate of Pharmaceutical Product)

• CTD/ACTD Dossier

• Free Sale Certificate

• Batch Manufacturing Records (BMR/BPR)

• Stability Data under ICH guidelines

• Bioequivalence and Validation Reports

All documentation adheres to international requirements for regulatory filings in Asia, Africa, Latin America, and the CIS region.

Custom Packaging & Labeling

Taj Pharma offers complete customization options for global buyers:

• Blister or Alu-Alu packaging in boxes of 10, 14, or 28 tablets.

• Private labeling with your brand name and design.

• Packaging compliant with country-specific pharmaceutical norms.

• Export-grade cartons and moisture-resistant primary packs to ensure stability.

Shelf-life, Storage, and Dosage Form

• Dosage Form: Extended-release oral tablets

• Strength: 2mg

• Shelf-life: 24–36 months (depending on stability data)

• Storage Conditions: Store below 25°C, protect from moisture and direct sunlight.

Export Certifications

Taj Pharma’s manufacturing units are accredited with globally recognized certifications, including:

• WHO-GMP Certification

• EU-GMP (in process for selected facilities)

• ISO 9001:2015

• COPP (for multiple countries)

• PIC/S Compliant Manufacturing Practices

• CTD/ACTD Dossiers ready for regulatory submission

Target Countries & Export Markets

Taj Pharma exports Ropinirole Extended-Release Tablet 2mg to over 50 countries worldwide, including:

• Asia: Vietnam, Philippines, Myanmar, Sri Lanka, Bangladesh

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

• CIS Countries: Ukraine, Georgia, Uzbekistan, Kazakhstan

• Middle East: Iraq, UAE, Oman, Yemen

• Latin America: Peru, Bolivia, Ecuador

• Europe: Belarus, Romania (for tender supply)

Why  is the Most Trusted Ropinirole Extended-Release Tablet 2mg Manufacturer in India

A. State-of-the-Art Manufacturing Facilities

Taj Pharma’s advanced manufacturing plant in Vapi, Gujarat is equipped with modular cleanrooms, automated production lines, and cutting-edge quality control laboratories. The facility complies with cGMP and PIC/S guidelines, ensuring superior purity, stability, and uniformity of each tablet.

Each batch of Ropinirole Extended-Release Tablet 2mg undergoes rigorous in-process and post-production testing, guaranteeing consistent quality and therapeutic efficacy.

B. Affordable Pricing & Quality Assurance

Taj Pharma believes in making global healthcare affordable. The company ensures competitive pricing without compromising on quality through:

• Economies of scale in bulk production

• In-house API sourcing and formulation

• Strict adherence to pharmacopoeial standards (BP/USP/EP/IP)

• Robust Quality Management System (QMS) for zero-defect manufacturing

C. Global Presence & Supply Chain Support

Taj Pharma’s export division ensures seamless logistics and documentation support for buyers across continents. The company offers:

• Door-to-port delivery

• Assistance with import permits, registration dossiers, and tenders

• Regulatory compliance support

• On-time shipment tracking and inventory management

With its reliable global supply chain, Taj Pharma has become a preferred partner for government institutions, hospitals, distributors, and NGOs.

D. Top 20 Countries Exporting

Taj Pharma currently exports Ropinirole Extended-Release Tablet 2mg and other neurological drugs to:

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification

Partner with Taj Pharma Today

If you are an importer, distributor, or pharmaceutical buyer, looking for a trusted WHO-GMP-certified manufacturer of Ropinirole Extended-Release Tablet 2mg, Taj Pharma is your most reliable partner.

Contact Taj Pharma today for:

• Competitive bulk export prices

• Private labeling and contract manufacturing

• Regulatory dossier support

• PCD Pharma Franchise opportunities across India and abroad

📞 Contact:
Taj Pharmaceuticals Ltd.
Vapi, Gujarat, India
🌐 www.tajpharma.in
✉️ Email: info@tajpharma.com

7. Top 20 FAQs 

1. What is Ropinirole Extended-Release Tablet 2mg used for?
It is used to treat Parkinson’s disease and Restless Legs Syndrome, helping improve muscle control and reduce tremors.

2. Who manufactures Ropinirole Extended-Release Tablet 2mg in India?
Taj Pharma is a leading Ropinirole Extended-Release Tablet 2mg manufacturer and supplier in India, exporting globally.

3. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma’s facility in Vapi, Gujarat is WHO-GMP, ISO 9001:2015, and COPP-certified.

4. Can buyers request private labeling?
Yes, Taj Pharma offers custom branding, labeling, and packaging for international clients.

5. What is the shelf-life of Ropinirole ER 2mg?
The standard shelf life is 24 to 36 months under recommended storage conditions.

6. Does Taj Pharma export to Africa and Latin America?
Yes, Taj Pharma exports to 50+ countries, including African, Latin American, and CIS regions.

7. What is the therapeutic class of Ropinirole?
Ropinirole belongs to the dopamine agonist class of drugs.

8. What are common side effects?
Dizziness, nausea, fatigue, and heartburn are common and usually mild.

9. Is Ropinirole ER 2mg safe with other Parkinson’s drugs?
Yes, it can be combined with Levodopa or Carbidopa under medical supervision.

10. Can Taj Pharma supply for government tenders?
Absolutely, Taj Pharma regularly participates in MOH and institutional supply tenders.

11. What is the export packaging standard?
Taj Pharma uses moisture-proof Alu-Alu or blister packs with export-grade cartons.

12. Does Taj Pharma provide CTD dossiers?
Yes, complete CTD/ACTD dossiers are available for regulatory filings.

13. How long does shipping take?
Standard delivery time is 4–6 weeks, depending on the destination and regulatory clearance.

14. Can small distributors order minimum quantities?
Yes, Taj Pharma accepts low MOQ orders for distributors and franchise partners.

15. What is the dosage frequency?
Typically, it’s once daily, as prescribed by a neurologist.

16. What storage conditions are required?
Store below 25°C in a dry, cool place, away from light.

17. Does Taj Pharma offer contract manufacturing?
Yes, Taj Pharma provides CMO and PCD Franchise services across India and globally.

18. What pharmacopoeia standard is followed?
Manufactured under BP/USP/IP specifications.

19. Can it be used for restless leg syndrome?
Yes, it is also indicated for Restless Legs Syndrome (RLS).

20. How can importers contact Taj Pharma?
Visit www.tajpharma.in or email info@tajpharma.com for quotes and documentation.

Taj Pharma continues to lead the Indian pharmaceutical export industry as a trusted manufacturer of Ropinirole Extended-Release Tablet 2mg. With WHO-GMP-certified facilities, strong regulatory support, and consistent global supply, Taj Pharma remains the 1 choice for importers and distributors worldwide.

Whether you’re seeking bulk supply, private label manufacturing, or franchise opportunities, Taj Pharma ensures quality, reliability, and global trust in every tablet produced.