Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+200mg

Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+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.

Attach dispensing label as per end country.

Introduction to Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+200mg: Precision Balancing in Parkinson’s Therapy

Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+200mg represent a meticulously calibrated triple-combination therapy specifically formulated to address the complex needs of patients with moderate Parkinson’s disease who require enhanced therapeutic support without the full intensity of maximum dosing. This balanced formulation delivers an optimized ratio of components that provides substantial dopaminergic activity while maintaining a favorable side effect profile. The strategic 50mg+100mg+200mg combination offers a sophisticated middle-ground approach, making it particularly valuable for patients transitioning from standard levodopa preparations to more advanced combination therapies.

The enhanced carbidopa component (50mg) provides robust peripheral dopa-decarboxylase inhibition, ensuring efficient central nervous system delivery of levodopa while minimizing peripheral conversion and associated side effects. The moderate levodopa content (100mg) delivers sufficient dopamine precursor for meaningful symptomatic control while reducing the risk of peak-dose dyskinesias that can occur with higher doses. The full entacapone strength (200mg) maintains comprehensive catechol-O-methyltransferase inhibition, extending levodopa’s therapeutic window and promoting more consistent symptom control throughout the dosing interval.

Global Demand and Therapeutic Applications:
The international demand for Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+200mg demonstrates consistent growth, driven by several pivotal factors:

• Moderate Disease Management: Increasing recognition of patients in intermediate Parkinson’s disease stages requiring more than basic therapy but not yet needing maximum dosing.

• Therapeutic Transition Protocols: Essential role in treatment escalation pathways as patients advance from standard to enhanced combination therapies.

• Balanced Efficacy-Safety Profile: Growing preference for formulations that offer meaningful symptom control while minimizing treatment-emergent complications.

• Individualized Treatment Approaches: Enhanced focus on tailored dosing strategies that match specific patient needs and tolerance levels.

This substantial global demand underscores the necessity for a highly reliable and precision-focused Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+200mg Supplier capable of maintaining exacting quality standards for this balanced combination therapy.

 Essential Details for Importers & Exporters

Procuring balanced 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 precise ratio 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 balanced neurological medications:

• Protective Blister Packing: Alu-Alu blister packs with superior moisture barrier properties and clear strength identification.

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

• Precise Ratio Labeling: Clear labeling with exact strength designation for all three active components.

• Comprehensive Information Leaflets: Detailed patient information with specific guidance for balanced triple therapy administration.

➤ 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 Balanced Triple Therapy Manufacturer

Selecting Taj Pharma for precision 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 precision combination drug manufacturing and comprehensive quality control systems. We employ sophisticated manufacturing technologies including calibrated granulation processes, precision compression systems, and advanced 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+100mg+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 balanced 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 balanced 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 therapeutic advantage of this balanced formulation?
It provides enhanced carbidopa coverage for better levodopa utilization while maintaining moderate levodopa dosing to balance efficacy and dyskinesia risk.

2. Who is the licensed manufacturer?
Taj Pharma Ltd. is a leading Carbidopa, Levodopa and Entacapone Tablets 50mg+100mg+200mg Manufacturer in India with comprehensive regulatory approvals.

3. How does this formulation benefit patients with moderate motor fluctuations?
It offers extended therapeutic coverage through entacapone while providing optimized levodopa delivery for patients beyond basic therapy needs.

4. What is the typical dosing schedule?
Usually administered 3 to 4 times daily, with timing adjusted to match individual motor fluctuation patterns.

5. How does the enhanced carbidopa component improve therapy?
The 50mg carbidopa provides more complete peripheral decarboxylase inhibition, reducing peripheral conversion and enhancing central nervous system delivery.

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

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

8. How is manufacturing precision ensured for specific ratio combinations?
Through validated blending processes, precision weighing systems, and comprehensive content uniformity testing.

9. Can you supply to markets with specific combination therapy regulations?
Yes, we have extensive experience meeting regulatory requirements for balanced combination 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 patient population is ideally suited for this strength?
Patients with moderate Parkinson’s disease experiencing motor fluctuations who require enhanced therapy beyond basic levodopa/carbidopa.

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

13. What is your production capacity for balanced combination therapies?
We have dedicated production lines with precision controls for specific ratio formulations.

14. What are the key monitoring parameters?
Regular assessment of motor function, monitoring for dyskinesias, and evaluation of “off” time reduction.

15. How should treatment be initiated with this formulation?
Typically started in patients already stabilized on levodopa who require enhanced therapy for improved symptom control.

16. Are there specific administration considerations?
Should be taken on an empty stomach to optimize absorption, with consistent timing relative to meals.

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

18. Can this formulation be used as initial therapy?
Generally reserved for patients who have demonstrated response to levodopa and require enhanced combination therapy.

19. How can healthcare institutions request technical documentation?
Qualified institutions can request comprehensive technical data through our official channels with proper credentials.

20. What support materials do you provide for healthcare professionals?
We offer detailed product monographs, clinical data summaries, and patient education materials for comprehensive support.