Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg

Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Carbidopa, Levodopa and Entacapone Tablets 12.5mg+50mg+200mg
B) Carbidopa, Levodopa and Entacapone Tablets 18.75mg+75mg+200mg
C) Carbidopa, Levodopa and Entacapone Tablets 37.5mg+150mg+200mg
D) Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+200mg
E) Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg
F) Carbidopa, Levodopa and Entacapone Tablets 31.25mg+125mg+200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Carbidopa, Levodopa and Entacapone Tablets 12.5mg+50mg+200mg
Each film coated tablet contains:
Carbidopa USP
Equivalent to Carbidopa anhydrous………….12.5mg
Levodopa USP………………………………………………50mg
Entacapone USP……………………………………………200mg
Excipients…………………………………………………… q.s.
Colours: Quinizarine green ss

B) Carbidopa, Levodopa and Entacapone Tablets 18.75mg+75mg+200mg
Each film coated tablet contains:
Carbidopa USP
Equivalent to Carbidopa anhydrous………….18.75mg
Levodopa USP………………………………………………75mg
Entacapone USP……………………………………………200mg
Excipients…………………………………………………… q.s.
Colours: Red oxide of iron

C) Carbidopa, Levodopa and Entacapone Tablets 37.5mg+150mg+200mg
Each film coated tablet contains:
Carbidopa USP
Equivalent to Carbidopa anhydrous………….37.5mg
Levodopa USP………………………………………………150mg
Entacapone USP……………………………………………200mg
Excipients…………………………………………………… q.s.
Colours: Ponceau 4 R

D) Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+200mg
Each film coated tablet contains:
Carbidopa USP
Equivalent to Carbidopa anhydrous………….50mg
Levodopa USP………………………………………………100mg
Entacapone USP……………………………………………200mg
Excipients…………………………………………………… q.s.
Colours: Titanium dioxide

E) Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg
Each film coated tablet contains:
Carbidopa USP
Equivalent to Carbidopa anhydrous………….50mg
Levodopa USP………………………………………………200mg
Entacapone USP……………………………………………200mg
Excipients…………………………………………………… q.s.
Colours: Indigo carmine aluminum lake

F) Carbidopa, Levodopa and Entacapone Tablets 31.25mg+125mg+200mg
Each film coated tablet contains:
Carbidopa USP
Equivalent to Carbidopa anhydrous………….31.25mg
Levodopa USP………………………………………………125mg
Entacapone USP……………………………………………200mg
Excipients…………………………………………………… q.s.
Colours: Lake of indigo carmine

THERAPEUTIC INDICATIONS:

Carbidopa, entacapone, and levodopa combination is used to treat Parkinson’s disease, sometimes called shaking palsy. Parkinson’s disease is a disorder of the central nervous system (brain and spinal cord).

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 Neurologist 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 Neurologist.

Introduction to Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg: High-Potency Management of Advanced Parkinson’s Disease

Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg represent a sophisticated high-strength triple-combination therapy specifically formulated for patients with moderate to advanced Parkinson’s disease who require substantial dopaminergic support. This enhanced formulation delivers a significantly higher dose of both carbidopa and levodopa compared to standard combinations, while maintaining the optimal 200mg entacapone strength for comprehensive COMT inhibition. The strategic 50mg+200mg+200mg ratio provides robust symptom control through enhanced dopaminergic activity, making it particularly valuable for patients with significant motor fluctuations and pronounced “wearing-off” phenomena.

The elevated carbidopa component (50mg) provides enhanced peripheral dopa-decarboxylase inhibition, ensuring more efficient central delivery of levodopa while minimizing peripheral side effects. The increased levodopa content (200mg) delivers substantial dopamine precursor for conversion to active dopamine in the brain, addressing the profound dopaminergic deficiency characteristic of advanced Parkinson’s disease. The entacapone component (200mg) maintains its crucial role as a catechol-O-methyltransferase inhibitor, extending levodopa’s plasma half-life and promoting more sustained therapeutic effects throughout the dosing interval.

Global Demand and Therapeutic Applications:
The international demand for Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg demonstrates consistent growth, driven by several critical factors:

• Advanced Disease Management: Increasing prevalence of patients progressing to moderate and advanced Parkinson’s disease stages requiring higher-dose therapy.

• Optimized Symptom Control: Growing recognition of the need for robust dopaminergic support in patients with significant motor complications.

• Therapeutic Escalation Protocols: Essential role in treatment algorithms as patients require upward dose titration for adequate symptom management.

• Quality of Life Preservation: Enhanced focus on maintaining functional independence and reducing disabling “off” periods in advanced disease.

This substantial global demand underscores the necessity for a highly reliable and precision-focused Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg Supplier capable of maintaining exacting quality standards for this high-potency combination therapy.

Essential Details for Importers & Exporters

Procuring high-potency neurological combination therapies requires a manufacturer with advanced technological capabilities, robust quality systems, and comprehensive regulatory expertise. Taj Pharma is systematically structured to provide a seamless and compliant sourcing experience for international partners requiring specialized neurological medications.

➤ Regulatory Documentation and Compliance

We provide a complete suite of documentation to facilitate smooth market entry and regulatory compliance:

• Certificate of Pharmaceutical Product (COPP): Issued in accordance with WHO specifications and international regulatory standards.

• WHO-GMP Certificate: Our manufacturing facility maintains full compliance with WHO Good Manufacturing Practices.

• EU-GMP Compliance: Our plant is designed and operated to meet stringent European Good Manufacturing Practice standards.

• Certificate of Analysis (CoA): Batch-specific documentation providing comprehensive analytical results for all three active components with enhanced potency verification.

• CTD Dossier: Complete Common Technical Document prepared for regulatory submissions across various international markets.

• Stability Studies Data: Extensive data supporting the product’s shelf life under recommended storage conditions.

➤ Custom Packaging & Labeling

We offer specialized packaging solutions tailored to high-potency neurological medications:

• Enhanced Barrier Blister Packing: Alu-Alu blister packs with superior moisture protection and clear high-strength identification.

• Secure Bottle Packaging: HDPE bottles with induction seals, tamper-evident closures, and desiccant canisters.

• Prominent Strength Labeling: Clear labeling with precise high-strength designation for all three active ingredients.

• Comprehensive Information Leaflets: Detailed patient information with specific guidance for high-potency triple therapy.

➤ Shelf-Life, Storage, and Dosage Form

• Dosage Form: Film-coated tablet for optimal stability and precise dosing of multiple high-potency ingredients.

• Shelf-Life: 24 months from the date of manufacture when stored under recommended conditions.

• Storage Conditions: Store below 30°C in a dry place. Protect from light and moisture. Maintain in original packaging until administration.

➤ Target Export Markets & Certifications

Why Taj Pharma is the Most Trusted High-Strength Triple Therapy Manufacturer

Selecting Taj Pharma for high-potency combination therapy manufacturing means partnering with an organization where technological innovation, quality assurance, and manufacturing precision are fundamental to our operational philosophy.

➤ State-of-the-Art Manufacturing & Quality Systems

Our advanced manufacturing facility in Vapi features specialized equipment for high-potency combination drug manufacturing and comprehensive quality control systems. We employ sophisticated manufacturing technologies including precision high-shear granulation, advanced compression systems, and multi-layer coating capabilities, supported by rigorous quality testing using HPLC, dissolution apparatus, and other advanced analytical instruments for all three active components.

➤ Competitive Pricing & Quality Commitment

Through manufacturing expertise and operational efficiency, we offer Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg at competitive prices while maintaining uncompromised quality standards. This enables sustainable access to advanced Parkinson’s therapy while providing our partners with reliable commercial value.

➤ Global Supply Chain & Regulatory Expertise

Our experienced regulatory and logistics teams ensure consistent international distribution with complete documentation support. We maintain established partnerships with global pharmaceutical logistics providers and offer comprehensive regulatory guidance for specific market requirements.

Technical Product Specification Table

Partner with a Leader in Advanced Neurological Medicine

Choosing the right manufacturing partner for high-potency combination therapies is crucial for ensuring consistent supply of quality medications for advanced Parkinson’s disease patients. Taj Pharma offers a partnership built on manufacturing excellence, regulatory expertise, and shared commitment to advancing global neurological care.

Contact Taj Pharma today to discuss your requirements for high-potency Parkinson’s medications, request a competitive quotation, or obtain samples and comprehensive product documentation. Let us be your trusted partner for quality neurological pharmaceuticals.

Contact Taj Pharma

Head Office:
Tel. No.: +91 – 22 – 2637 4592 / 2637 4593 (IST)
Fax: +91 – 22 – 2634 1274
Gen. Enquiry: +91 84484 44095

WhatsApp Support:
Mobile: +91 74 0000 9975 / +91 74 0000 9976

Email: info@tajpharma.com

 Top 20 FAQs  

1. What is the specific indication for this high-strength combination?
It is indicated for advanced Parkinson’s disease patients with significant motor fluctuations who require higher dopaminergic support.

2. Who is the licensed manufacturer?
Taj Pharma Ltd. is a leading Carbidopa, Levodopa and Entacapone Tablets 50mg+200mg+200mg Manufacturer in India with comprehensive regulatory approvals.

3. How does this high-strength formulation benefit advanced patients?
Provides enhanced symptom control through increased levodopa delivery and extended duration of action for complex motor fluctuations.

4. What is the typical dosing frequency?
Usually administered 3 to 4 times daily, with individual dosing tailored to the patient’s specific motor fluctuation pattern.

5. How does the higher carbidopa component enhance therapy?
The increased carbidopa (50mg) provides more effective peripheral decarboxylase inhibition, reducing peripheral side effects and improving central delivery.

6. Do you provide enhanced documentation for high-potency products?
Yes, we supply comprehensive documentation including COPP, WHO-GMP, and detailed Certificates of Analysis with potency verification.

7. What is your minimum order quantity for high-strength formulations?
We offer flexible MOQs to accommodate both institutional requirements and distributor needs.

8. How is manufacturing precision ensured for high-potency combinations?
Through validated high-shear processes, precision blending technology, and enhanced content uniformity testing.

9. Can you supply to markets with stringent high-potency regulations?
Yes, we have extensive experience meeting specific regulatory requirements for high-strength neurological medications.

10. What is the shelf life?
We provide a 24-month shelf life from the date of manufacture when stored under recommended conditions.

11. What specific patient population requires this strength?
Patients with advanced Parkinson’s disease experiencing significant “wearing-off” phenomena despite standard-dose therapy.

12. Do you offer PCD Pharma Franchise for specialized strengths?
We collaborate with qualified distributors demonstrating expertise in neurological medication management.

13. What is your production capacity for high-potency combinations?
We have dedicated production lines with enhanced engineering controls for high-strength formulations.

14. What are the enhanced monitoring requirements?
Close observation for dyskinesias, orthostatic hypotension, and neuropsychiatric effects due to the higher dopaminergic load.

15. How should treatment be initiated with this high-strength formulation?
Typically reserved for patients already stabilized on lower doses who require upward titration for optimal symptom control.

16. Are there specific dietary considerations?
Maintain consistent protein distribution throughout the day to avoid interference with levodopa absorption.

17. What storage conditions are critical?
Store below 30°C in dry conditions, protected from light and moisture, in original packaging.

18. Can this formulation cause increased dyskinesias?
Yes, the higher levodopa content may initially increase dyskinesias, requiring careful dose adjustment.

19. How can healthcare institutions request samples?
Qualified institutions and distributors can request samples through our official channels with appropriate documentation.

20. What technical support do you provide for this high-strength product?
We offer comprehensive technical data, stability information, and clinical support materials for healthcare professionals.