Carbidopa, Levodopa and Entacapone Tablets 37.5mg+150mg+200mg

Carbidopa, Levodopa and Entacapone Tablets 37.5mg+150mg+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 37.5mg+150mg+200mg: Strategic Intermediate Therapy in Parkinson’s Management

Carbidopa, Levodopa and Entacapone Tablets 37.5mg+150mg+200mg represent a meticulously calibrated triple-combination therapy specifically formulated to address the therapeutic needs of patients progressing from initial Parkinson’s disease treatment to more advanced management strategies. This intermediate formulation delivers an optimized ratio that provides enhanced therapeutic benefits while maintaining careful control over potential side effects. The strategic 37.5mg+150mg+200mg combination offers a sophisticated stepping stone in treatment escalation, making it particularly valuable for patients who require more than basic levodopa therapy but are not yet ready for maximum dosing regimens.

The enhanced carbidopa component (37.5mg) provides substantial peripheral dopa-decarboxylase inhibition, ensuring efficient central nervous system delivery of levodopa while minimizing peripheral conversion and associated gastrointestinal side effects. The moderate levodopa content (150mg) delivers meaningful dopamine precursor for significant symptomatic control while carefully managing the risk of peak-dose dyskinesias. The full entacapone strength (200mg) maintains comprehensive catechol-O-methyltransferase inhibition, extending levodopa’s plasma half-life and promoting more consistent symptom control throughout the dosing interval, effectively reducing “wearing-off” phenomena.

Global Demand and Therapeutic Applications:
The international demand for Carbidopa, Levodopa and Entacapone Tablets 37.5mg+150mg+200mg demonstrates steady growth, driven by several critical factors:

• Progressive Disease Management: Increasing recognition of patients transitioning from early to moderate Parkinson’s disease stages requiring enhanced therapeutic support.

• Treatment Escalation Protocols: Essential role in structured treatment algorithms as patients advance from basic to intermediate combination therapies.

• Optimized Risk-Benefit Profile: Growing preference for formulations that offer substantial symptom control while carefully managing potential treatment complications.

• Individualized Dosing Strategies: Enhanced focus on tailored approaches that match specific patient progression patterns and tolerance levels.

This substantial global demand underscores the necessity for a highly reliable and precision-focused Carbidopa, Levodopa and Entacapone Tablets 37.5mg+150mg+200mg Supplier capable of maintaining exacting quality standards for this optimized combination therapy.

Essential Details for Importers & Exporters

Procuring optimized 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 intermediate 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 optimized neurological medications:

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

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

• Precise Intermediate Labeling: Clear labeling with exact strength designation highlighting the optimized therapeutic ratio.

• Comprehensive Information Leaflets: Detailed patient information with specific guidance for intermediate 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 Optimized Triple Therapy Manufacturer

Selecting Taj Pharma for precision intermediate 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 37.5mg+150mg+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 optimized combination therapies is crucial for ensuring consistent supply of quality medications for progressing 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 intermediate 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 positioning of this intermediate formulation?
It serves as an optimized step-up therapy for patients requiring enhanced treatment beyond basic levodopa but not yet needing maximum dosing regimens.

2. Who is the licensed manufacturer?
Taj Pharma Ltd. is a leading Carbidopa, Levodopa and Entacapone Tablets 37.5mg+150mg+200mg Manufacturer in India with comprehensive regulatory approvals.

3. How does this formulation benefit patients with emerging motor fluctuations?
It provides extended therapeutic coverage through entacapone while delivering enhanced levodopa support for patients developing “wearing-off” phenomena.

4. What is the typical administration schedule?
Usually administered 3 to 4 times daily, with precise timing adjusted to match individual motor fluctuation patterns and symptom severity.

5. How does the intermediate carbidopa component optimize therapy?
The 37.5mg carbidopa provides enhanced peripheral decarboxylase inhibition compared to standard formulations, improving central delivery while maintaining balanced side effect profile.

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

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

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

9. Can you supply to markets with specific intermediate therapy regulations?
Yes, we have extensive experience meeting regulatory requirements for intermediate 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 intermediate strength?
Patients with progressing Parkinson’s disease who experience emerging motor complications and require enhanced therapy beyond basic levodopa/carbidopa.

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

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

14. What are the essential monitoring parameters?
Regular assessment of motor fluctuations, monitoring for emerging dyskinesias, and evaluation of “off” time reduction and symptom control.

15. How should treatment transition to this formulation be managed?
Typically initiated in patients demonstrating suboptimal control with standard levodopa preparations, with careful upward titration from previous regimens.

16. Are there specific administration timing 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 initial combination therapy?
Generally reserved for patients who have demonstrated clear response to levodopa and require enhanced combination therapy for optimal symptom management.

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, clinical efficacy data, and patient management guidelines for optimal therapeutic implementation.