Carbidopa, Levodopa and Entacapone Tablets 31.25mg+125mg+200mg

Carbidopa, Levodopa and Entacapone Tablets 31.25mg+125mg+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 31.25mg+125mg+200mg: Advanced Synergy in Parkinson’s Therapy

Carbidopa, Levodopa and Entacapone Tablets 31.25mg+125mg+200mg represent a sophisticated triple-combination therapy that addresses the complex pharmacological needs of advanced Parkinson’s disease management. This innovative formulation combines three complementary mechanisms to optimize dopaminergic therapy while minimizing the motor complications that often develop with long-term levodopa treatment. The strategic combination delivers comprehensive symptom control through synergistic action on the dopaminergic pathway, making it particularly valuable for patients experiencing “wearing-off” phenomena and other motor fluctuations.

The specific ratio of 31.25mg Carbidopa, 125mg Levodopa, and 200mg Entacapone represents a carefully calibrated balance that maximizes therapeutic efficacy while managing side effect profiles. Carbidopa functions as a peripheral dopa-decarboxylase inhibitor, preventing the premature conversion of levodopa to dopamine in the periphery. Levodopa serves as the direct dopamine precursor that crosses the blood-brain barrier to replenish depleted dopamine stores in the substantia nigra. Entacapone provides the crucial third component as a catechol-O-methyltransferase (COMT) inhibitor, extending levodopa’s plasma half-life and promoting more sustained dopamine delivery to the brain.

Global Demand and Therapeutic Applications:
The international demand for Carbidopa, Levodopa and Entacapone Tablets 31.25mg+125mg+200mg continues to demonstrate significant growth, driven by several critical factors:

• Aging Global Population: Increasing prevalence of Parkinson’s disease associated with demographic shifts toward older populations worldwide.

• Treatment Optimization Needs: Growing recognition of the importance of managing motor complications in advanced Parkinson’s disease.

• Therapeutic Advancements: Shift toward combination therapies that address multiple aspects of Parkinson’s pathophysiology simultaneously.

• Quality of Life Focus: Enhanced emphasis on maintaining functional capacity and reducing “off” time in Parkinson’s disease management.

This substantial global demand underscores the necessity for a highly reliable and precision-focused Carbidopa, Levodopa and Entacapone Tablets 31.25mg+125mg+200mg Supplier capable of maintaining exacting quality standards for this complex combination therapy.

Essential Details for Importers & Distributors

Procuring sophisticated 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.

• 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 neurological medications:

• High-Barrier Blister Packing: Alu-Alu blister packs with superior moisture protection and enhanced patient-friendly features.

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

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

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

➤ Shelf-Life, Storage, and Dosage Form

• Dosage Form: Film-coated tablet for optimal stability and precise dosing of multiple active 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 Triple Therapy Manufacturer & Exporter

Selecting Taj Pharma for sophisticated 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 combination drug manufacturing and comprehensive quality control systems. We employ sophisticated manufacturing technologies including precision granulation, multi-layer compression capabilities, and advanced coating systems, 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 31.25mg+125mg+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

Call to Action:

Choosing the right manufacturing partner for sophisticated combination therapies is crucial for ensuring consistent supply of quality medications for 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 Parkinson’s disease 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 primary indication for this triple combination?
It is indicated for the treatment of Parkinson’s disease in patients experiencing “wearing-off” phenomena despite levodopa therapy.

2. Who is the licensed manufacturer?
Taj Pharma Ltd. is a leading Carbidopa, Levodopa and Entacapone Tablets 31.25mg+125mg+200mg Manufacturer in India with comprehensive regulatory approvals.

3. How does this combination improve upon standard levodopa therapy?
The addition of entacapone extends the duration of levodopa’s effect, reducing “off” time and smoothing motor fluctuations.

4. What is the recommended dosing schedule?
Typically administered 3 to 6 times daily, with individual dosing based on therapeutic response and tolerability.

5. How should this medication be taken relative to meals?
Should be taken on an empty stomach, at least 30-60 minutes before or 1-2 hours after meals, to optimize absorption.

6. Do you provide complete export documentation for combination products?
Yes, we supply all necessary documentation including COPP, WHO-GMP, and comprehensive Certificates of Analysis for all active ingredients.

7. What is your minimum order quantity?
We offer flexible MOQs to accommodate both institutional purchases and distributor requirements.

8. How is product quality consistency maintained for combination therapy?
Through validated manufacturing processes, rigorous in-process controls, and comprehensive finished product testing for all components.

9. Can you supply to markets with stringent neurological medication regulations?
Yes, we have extensive experience meeting specific regulatory requirements for anti-Parkinsonian medications across multiple markets.

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 are the important dietary considerations?
High-protein meals may interfere with absorption; patients should maintain consistent protein intake throughout the day.

12. Do you offer PCD Pharma Franchise opportunities?
We collaborate with qualified distributors who demonstrate understanding of neurological medication protocols.

13. What is your production capacity for combination therapies?
We have substantial production capacity with dedicated lines for complex combination formulations.

14. What are the most common side effects?
May include dyskinesia, nausea, dizziness, orthostatic hypotension, and urine discoloration.

15. How should treatment be initiated?
Typically started at lower doses with gradual upward titration based on individual response and tolerability.

16. Are there significant drug interactions?
Interactions may occur with iron supplements, MAO inhibitors, and certain antihypertensive medications.

17. What monitoring is recommended during therapy?
Regular assessment of motor function, blood pressure monitoring, and periodic liver function tests.

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

19. Can this medication cause sudden sleep episodes?
Yes, patients should be cautioned about the potential for sudden somnolence during daily activities.

20. How can qualified buyers request samples?
Healthcare institutions and serious distributors can request samples through our official channels with appropriate documentation.