Ropinirole Extended-Release Tablet 12mg

Ropinirole Extended-Release Tablets 12mg 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 Understanding Ropinirole Extended-Release Tablet 12mg and Its Global Demand

Ropinirole Extended-Release Tablet 12mg is a dopamine agonist used to treat Parkinson’s disease, a progressive nervous system disorder that affects movement and muscle control. It works by stimulating dopamine receptors in the brain, helping to manage symptoms such as tremors, stiffness, and slow movements.

The extended-release (ER) form allows for once-daily dosing, improving patient adherence and maintaining stable drug levels throughout the day. A 12mg dose is often used as a maintenance therapy following careful titration under medical supervision.

Globally, the demand for Ropinirole Extended-Release Tablets 12mg is rising due to the increasing prevalence of Parkinson’s disease, especially among aging populations. As healthcare providers seek high-quality, cost-effective generics, India’s pharmaceutical manufacturers—led by Taj Pharma—play a crucial role in meeting this global need.

 Clinical Uses and Benefits

• Primary Indication: Parkinson’s Disease (monotherapy or adjunct to levodopa therapy)

• Mechanism of Action: Non-ergoline dopamine agonist that mimics dopamine effects

• Dosage Form: Once-daily extended-release tablets (12mg strength)

• Benefits:

  • Reduces “off” episodes in Parkinson’s therapy

  • Maintains consistent plasma concentration

  • Enhances patient compliance with single daily dose

  • Suitable for long-term management

Common side effects may include dizziness, fatigue, nausea, anxiety, and mild gastrointestinal discomfort, all of which are typically manageable with dose adjustments.

Ropinirole Extended-Release Tablet 12mg Manufacturer and Supplier in India 

Taj Pharma Ltd., headquartered in Vapi, Gujarat, India, is a well-established WHO-GMP, ISO, and FDA-approved pharmaceutical manufacturer, renowned for its excellence in producing high-quality generics. As a leading Ropinirole Extended-Release Tablet 12mg manufacturer and supplier, Taj Pharma provides superior formulations at affordable prices to global partners and domestic markets.

Taj Pharma ensures that every Ropinirole Extended-Release Tablet 12mg batch is produced under stringent quality standards, ensuring efficacy, purity, and safety.

Key Advantages of Taj Pharma’s Ropinirole Extended-Release Tablet 12mg:

• Extended-release formulation ensures steady therapeutic levels.

• Manufactured in WHO-GMP certified facilities meeting global regulatory standards.

• Custom packaging options for export partners.

• Comprehensive regulatory documentation for market registration.

• Global distribution network across more than 80 countries.

Technical Product Specifications 

Comprehensive Support for Importers, Exporters, and Buyers

1. Regulatory Documentation

Taj Pharma provides complete regulatory support, including:

• CTD/eCTD Dossiers

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Stability Data (Zone-wise)

• Free Sale Certificate (FSC)

• Bioequivalence Reports (if required)

2. Packaging and Labeling

Customizable packaging solutions ensure compliance with target country regulations:

• Private labeling and language customization

• Tamper-proof and moisture-resistant packaging

• Batch coding and serialization compliant with global track & trace norms

3. Storage and Shelf-Life

The product’s shelf life extends up to 36 months, ensuring long-term stability. It should be stored at controlled room temperature, away from excessive heat and humidity.

4. Export Certifications

Taj Pharma holds international approvals, including:

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

• EU-GMP equivalence

• COPP (Certificate of Pharmaceutical Product)

• ISO 9001:2015 certification

• Comprehensive CTD Dossiers

5. Target Export Markets

Taj Pharma’s Ropinirole Extended-Release Tablet 12mg is exported across multiple continents:

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

• Asia: Vietnam, Philippines, Sri Lanka, Thailand, Cambodia

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

• CIS & Europe: Russia, Ukraine, Georgia, Kazakhstan

• Latin America: Peru, Colombia, Chile, Guatemala

Why Taj Pharma is the Most Trusted Ropinirole Extended-Release Tablet 12mg Manufacturer & Exporter

1. State-of-the-Art Manufacturing

Taj Pharma’s advanced manufacturing plant in Vapi, Gujarat operates under strict WHO-GMP guidelines, employing automated production lines and cleanroom facilities that ensure high-quality output for regulated and semi-regulated markets.

2. Uncompromising Quality Assurance

Every product undergoes multi-stage quality testing—from raw material sourcing to finished product release—ensuring compliance with Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP) standards.

3. Global Supply Chain Network

Taj Pharma’s robust global logistics and PAN India distribution ensure seamless supply to hospitals, pharmacies, and distributors worldwide. The company’s efficient export team manages end-to-end documentation and shipping.

4. Competitive Pricing

By leveraging in-house API sourcing and cost-effective manufacturing, Taj Pharma offers affordable prices without compromising on quality—making it a preferred partner for importers and government tenders globally.

5. Research & Innovation

The R&D division continuously enhances product bioavailability and release profiles, ensuring Taj Pharma’s formulations stay at par with international standards.

6. Strong Regulatory Reputation

Taj Pharma’s products are approved in over 80 global regulatory authorities, building trust among health ministries, tender boards, and private importers.

Top 20 Countries Exporting Ropinirole Extended-Release Tablet 12mg  

India | UAE | Saudi Arabia | Oman | Kenya | Nigeria | South Africa | Ghana | Vietnam | Myanmar | Philippines | UK | Germany | France | Brazil | Chile | Peru | Colombia | Mexico | USA

 PAN India Presence

Taj Pharma proudly supplies Ropinirole Extended-Release Tablet 12mg PAN India, covering cities like Mumbai, Delhi, Ahmedabad, Hyderabad, Chennai, Kolkata, Bengaluru, and Pune.
The company offers PCD Pharma Franchise opportunities, providing monopoly rights, marketing support, and promotional materials for distributors and healthcare partners.

Best Price and Availability

Taj Pharma offers Ropinirole Extended-Release Tablet 12mg at the best price in Mumbai, Maharashtra, and PAN India, ensuring affordability for both domestic and export buyers. Bulk purchase and long-term supply contracts are also available.

Call to Action: Partner with Taj Pharma Today

Are you looking for a reliable Ropinirole Extended-Release Tablet 12mg manufacturer, supplier, or exporter in India?
Join hands with Taj Pharma—your trusted pharmaceutical partner with decades of global experience, world-class infrastructure, and a commitment to healthcare excellence.

📞 Contact Taj Pharma:
Email: info@tajpharma.com
Website: www.tajpharma.com
Head Office: Vapi, Gujarat, India

Top 20 FAQs  

1. What is Ropinirole Extended-Release Tablet 12mg used for?
It’s used to treat Parkinson’s disease symptoms like tremor, stiffness, and slow movement.

2. Who manufactures Ropinirole Extended-Release Tablet 12mg in India?
Taj Pharma Ltd. is a top WHO-GMP certified manufacturer and exporter of this formulation.

3. Is Ropinirole 12mg safe for long-term use?
Yes, under medical supervision, it is safe for long-term Parkinson’s management.

4. What are the common side effects?
Dizziness, nausea, fatigue, anxiety, and mild stomach discomfort.

5. What certifications does Taj Pharma hold?
WHO-GMP, ISO 9001, COPP, and CTD Dossiers are available.

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

7. Can Ropinirole be exported to regulated markets?
Yes, Taj Pharma supports exports to semi-regulated and regulated markets with full documentation.

8. Does Taj Pharma offer custom packaging?
Yes, packaging and labeling can be tailored for each country’s requirements.

9. What is the minimum order quantity (MOQ)?
MOQ depends on buyer needs—flexible for importers and tenders.

10. What is the dosage frequency?
Once daily, due to its extended-release formulation.

11. Is it available under PCD Pharma Franchise?
Yes, Taj Pharma provides PCD franchise opportunities across India.

12. Is it suitable for all stages of Parkinson’s disease?
It is prescribed based on the stage and response to other therapies.

13. Can Taj Pharma supply samples for registration?
Yes, samples and technical documents are provided for dossier submission.

14. Does Taj Pharma offer contract manufacturing?
Yes, they provide third-party and contract manufacturing services.

15. How does Ropinirole Extended-Release differ from immediate-release?
ER tablets provide steady release for 24 hours, reducing dosing frequency.

16. Is it approved by health authorities?
Yes, approved by CDSCO India and recognized internationally.

17. How should it be stored?
Store below 25°C, protected from moisture and direct sunlight.

18. Can it be taken with levodopa?
Yes, it can be used as adjunct therapy to levodopa.

19. What makes Taj Pharma different from others?
Commitment to quality, affordability, global compliance, and reliable delivery.

20. How to order Ropinirole Extended-Release Tablet 12mg from Taj Pharma?
Email info@tajpharma.com or visit www.tajpharma.com for order inquiries and quotations.

Taj Pharma stands as a leading Ropinirole Extended-Release Tablet 12mg manufacturer and exporter in India, offering world-class quality, regulatory compliance, and global distribution support. With cutting-edge facilities, cost-efficient production, and a deep focus on innovation, Taj Pharma continues to be the preferred partner for importers, distributors, and PCD franchise seekers worldwide.