Carbidopa, Levodopa and Entacapone Tablets 18.75mg+75mg+200mg

Carbidopa, Levodopa and Entacapone Tablets 18.75mg+75mg+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 18.75mg+75mg+200mg: Foundation of Advanced Parkinson’s Therapy

Carbidopa, Levodopa and Entacapone Tablets 18.75mg+75mg+200mg represent a meticulously calibrated triple-combination therapy specifically formulated to serve as the foundation for patients initiating advanced Parkinson’s disease treatment. This entry-level formulation delivers a carefully balanced ratio that introduces the benefits of triple therapy while maintaining a favorable side effect profile for treatment-naïve patients. The strategic 18.75mg+75mg+200mg combination offers a gentle yet effective introduction to comprehensive Parkinson’s management, making it particularly valuable for patients transitioning from basic levodopa therapy or those beginning combination treatment for the first time.

The moderate carbidopa component (18.75mg) provides sufficient peripheral dopa-decarboxylase inhibition to ensure efficient central nervous system delivery of levodopa while minimizing the risk of peripheral side effects. The conservative levodopa content (75mg) delivers adequate dopamine precursor for meaningful symptomatic control while carefully managing the potential for early-onset dyskinesias. The full entacapone strength (200mg) introduces comprehensive catechol-O-methyltransferase inhibition from therapy initiation, extending levodopa’s therapeutic window and establishing consistent symptom control patterns from the outset.

Global Demand and Therapeutic Applications:
The international demand for Carbidopa, Levodopa and Entacapone Tablets 18.75mg+75mg+200mg demonstrates consistent growth, driven by several critical factors:

• Early Combination Therapy: Increasing recognition of the benefits of introducing triple therapy earlier in Parkinson’s disease management.

• Treatment Initiation Protocols: Essential role in structured treatment algorithms for patients beginning advanced therapeutic regimens.

• Optimized Introduction Strategy: Growing preference for gentle introduction to combination therapy that balances efficacy with tolerability.

• Progressive Treatment Approach: Enhanced focus on establishing comprehensive treatment foundations that allow for smooth future escalation.

This substantial global demand underscores the necessity for a highly reliable and precision-focused Carbidopa, Levodopa and Entacapone Tablets 18.75mg+75mg+200mg Supplier capable of maintaining exacting quality standards for this foundational combination therapy.

Essential Details for Importers & Exporters

Procuring initial 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 initial 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 initial neurological medications:

• Starter Pack Blister Packing: Alu-Alu blister packs with superior moisture barrier properties and clear initial therapy identification.

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

• Clear Initial Therapy Labeling: Prominent labeling with exact strength designation highlighting the introductory therapeutic ratio.

• Comprehensive Starter Leaflets: Detailed patient information with specific guidance for initial triple therapy administration and titration.

➤ 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 Initial Triple Therapy Manufacturer

Selecting Taj Pharma for precision initial 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 18.75mg+75mg+200mg at competitive prices while maintaining uncompromised quality standards. This enables sustainable access to initial Parkinson’s combination 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 initial combination therapies is crucial for ensuring consistent supply of quality medications for patients beginning advanced Parkinson’s treatment. 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 initial 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 role of this initial formulation?
It serves as the foundation for introducing triple therapy to Parkinson’s patients, providing gentle yet effective symptom control with optimized tolerability.

2. Who is the licensed manufacturer?
Taj Pharma Ltd. is a leading Carbidopa, Levodopa and Entacapone Tablets 18.75mg+75mg+200mg Manufacturer in India with comprehensive regulatory approvals.

3. How does this formulation benefit patients beginning combination therapy?
It introduces the benefits of enhanced levodopa delivery and extended duration of action while minimizing initial side effect risks.

4. What is the recommended administration schedule?
Typically initiated with 3 to 4 doses daily, with timing adjusted based on individual symptom patterns and response.

5. How does the initial carbidopa component support therapy?
The 18.75mg carbidopa provides adequate peripheral decarboxylase inhibition for efficient central delivery while maintaining excellent initial tolerability.

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

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

8. How is manufacturing precision ensured for initial therapy ratios?
Through validated precision blending processes, automated weighing systems, and comprehensive content uniformity testing across all components.

9. Can you supply to markets with specific initial therapy regulations?
Yes, we have extensive experience meeting regulatory requirements for initial combination medications across multiple international 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 initial strength?
Patients beginning advanced Parkinson’s treatment who require enhanced therapy beyond basic levodopa but need gentle introduction to combination approaches.

12. Do you offer PCD Pharma Franchise for initial formulations?
We collaborate with qualified distributors demonstrating expertise in neurological disease management and patient education.

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

14. What are the essential monitoring parameters during initiation?
Regular assessment of symptom control, monitoring for emerging side effects, and evaluation of motor function improvement.

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

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

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

18. Can this formulation be used as first-line Parkinson’s therapy?
It serves as an excellent option for patients beginning advanced treatment who may benefit from early introduction of combination therapy.

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

20. What professional support materials do you provide?
We offer comprehensive product monographs, initial therapy guidelines, and patient education materials for optimal therapeutic implementation.