Cilostazol tablets 100mg

Cilostazol tablets 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Cilostazol tablets USP 50mg
2. Cilostazol tablets USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Cilostazol tablets USP 50mg
Each Un-coated tablet contains:
Cilostazol USP………………..……………50mg
Excipients………………………………..q.s
Colour: Sunset yellow FCF

2. Cilostazol tablets USP 100mg
Each Un-coated tablet contains:
Cilostazol USP………………..……………100mg
Excipients………………………………..q.s
Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Cilostazol improves the flow of blood through the blood vessels. It is used to reduce leg pain caused by poor circulation (intermittent claudication). Cilostazol makes it possible to walk farther before having to rest because of leg pain. Cilostazol is also indicated for secondary prevention in patients with a history of transient ischemic attacks or non-cardioembolic ischaemic stroke.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINES IN THE USP.

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician.

Attach dispensing label as per end country.

1. Introduction to Cilostazol Tablets 100mg 

Cilostazol Tablets 100mg represents the pinnacle of pharmacological intervention for severe intermittent claudication, offering the highest recommended dosage for patients with significant walking impairment due to peripheral artery disease. This maximum-strength formulation provides enhanced therapeutic benefits through its potent vasodilatory and antiplatelet actions, making it particularly valuable for patients with advanced disease or those requiring maximum therapeutic effect.

• Pharmacological Superiority: Cilostazol operates through selective inhibition of phosphodiesterase III, significantly increasing cyclic adenosine monophosphate (cAMP) levels in vascular smooth muscle and platelets. The 100mg dosage provides maximum inhibition of platelet aggregation and optimal vasodilation in the peripheral vasculature, particularly enhancing blood flow to the lower extremities. This high-potency formulation demonstrates significantly greater improvement in maximal walking distance compared to lower doses, typically showing substantial clinical benefits within 2-4 weeks of treatment initiation in responsive patients.

• Advanced Therapeutic Applications: This maximum-strength 100mg formulation serves critical roles in advanced cardiovascular therapeutics:

  • Severe symptomatic intermittent claudication management

  • Patients refractory to 50mg Cilostazol therapy

  • Advanced peripheral artery disease with significant functional limitation

  • Critical limb ischemia as adjunctive therapy

  • Diabetic patients with severe vasculopathic complications

  • Post-revascularization maintenance therapy

The international demand for Cilostazol 100mg continues to grow substantially, driven by the increasing prevalence of advanced cardiovascular diseases, aging global populations, and the need for effective high-potency treatments for severe peripheral artery disease. As a leading Cilostazol Tablets 100mg supplier, Taj Pharma addresses this critical healthcare need with precisely formulated tablets that ensure consistent maximum-strength therapeutic performance and optimal patient outcomes.

2. Comprehensive Export Solutions for International Pharmaceutical Importers

Regulatory Documentation & Quality Certifications

We provide exhaustive regulatory documentation packages with every international shipment:

• Enhanced Certificate of Analysis with comprehensive dissolution profiling

• WHO-formatted Certificate of Pharmaceutical Product (CPP)

• Complete CTD Dossier for streamlined regulatory submissions

• Stability studies data supporting 36-month shelf life

• Method validation reports and comparative bioavailability data

• High-potency manufacturing process validation documentation

Our advanced manufacturing infrastructure maintains prestigious international certifications:

• WHO-GMP Certified Manufacturing Facilities

• EU-GMP Compliance Standards

• ISO 9001:2015 Quality Management Systems

• ISO 14001:2015 Environmental Management Systems

• Validated high-potency cardiovascular drug manufacturing processes

Packaging Options & Product Specifications

• Primary Packaging: Pharmaceutical-grade blister packs (Alu-Alu) with enhanced cavity design

• Secondary Packaging: Professional carton systems with comprehensive multilingual information

• Shelf Life: 36 months from manufacturing date under proper storage conditions

• Storage Conditions: Below 30°C in dry environment, protected from light and moisture

• Labeling: Fully compliant with destination country regulations and high-potency cardiovascular medicine requirements

Global Export Network

Taj Pharma exports high-potency cardiovascular medications to numerous countries with established regulatory pathways:

3.   Competitive Advantages in High-Potency Cardiovascular Manufacturing

Advanced Manufacturing Infrastructure

Our WHO-GMP certified manufacturing plant incorporates specialized capabilities for high-potency formulations:

• Dedicated high-potency manufacturing suites with advanced environmental controls

• Precision granulation and compression technology for maximum-strength formulations

• Advanced coating systems for optimal high-dose drug delivery

• Comprehensive in-process quality control with automated monitoring systems

• State-of-the-art analytical instrumentation for high-potency quality verification

Enhanced Quality Assurance Protocols

• Raw Material Qualification: Rigorous testing of Cilostazol API and specialized excipients

• Content Uniformity Testing: Ensuring precise 100mg dosage accuracy across all tablets

• Dissolution Profile Testing: Verifying optimal drug release characteristics for high-potency formulation

• Stability Monitoring: Ongoing real-time and accelerated stability studies

• Impurity Profiling: Comprehensive identification and control of related substances

Global Supply Chain Expertise

Our specialized export management for high-potency cardiovascular medications provides:

• Advanced temperature-controlled shipping with environmental monitoring

• Real-time shipment tracking and enhanced security protocols

• Efficient customs clearance with comprehensive regulatory documentation

• Flexible logistics solutions for diverse market requirements

• Strict compliance with international pharmaceutical regulations

4. Technical Product Specifications

5. Contact Taj Pharma for Partnership Opportunities

We collaborate with various stakeholders in the global healthcare ecosystem:

• International pharmaceutical distributors and specialty wholesalers

• Government advanced healthcare programs and vascular medicine initiatives

• Specialized hospital networks and cardiovascular treatment centers

• PCD Pharma Franchise partners

• Vascular specialists and advanced cardiology practitioners

For competitive pricing and partnership opportunities, contact Taj Pharma today:

Contact Details:

• Telephone: +91-22-2637 4592 / +91-22-2637 4593 (IST)

• Fax: +91-22-2634 1274

• General Enquiries: +91-84484 44095

• Mobile/WhatsApp: +91-74000 09975 / +91-74000 09976

• Email: info@tajpharma.com

• Website: https://www.tajpharma.com

• Address: Taj Pharma Ltd, Vapi, Gujarat, India

6. Comprehensive FAQ Section

Q1. What is the primary indication for Cilostazol 100mg?
A1. Treatment of severe intermittent claudication symptoms in patients requiring maximum therapeutic effect for significant walking impairment.

Q2. How does the 100mg strength compare to lower doses?
A2. Provides superior improvement in maximal walking distance and is specifically for patients with severe symptoms or inadequate response to 50mg dosage.

Q3. What is the typical dosing schedule for 100mg tablets?
A3. Usually administered twice daily on an empty stomach, at least 30 minutes before or 2 hours after meals for optimal absorption.

Q4. Can you supply samples for bioequivalence studies?
A4. Yes, we provide comprehensive sample packages for regulatory testing and bioequivalence studies of high-potency formulations.

Q5. What is your production capacity for high-potency cardiovascular medications?
A5. We maintain significant dedicated production capacity with specialized high-potency manufacturing lines.

Q6. Are you certified for high-potency cardiovascular medicine manufacturing?
A6. Yes, we are a certified WHO-GMP manufacturer in India with specific expertise in high-potency cardiovascular medications.

Q7. What is the shelf life of your Cilostazol 100mg Tablets?
A7. 36 months when stored in original packaging under recommended conditions.

Q8. Do you offer specialized packaging for high-potency medications?
A8. Yes, we provide enhanced packaging with clear high-potency identification and safety features.

Q9. What export documentation do you provide for high-strength formulations?
A9. Complete documentation including enhanced COA, CPP, stability data, and all required international shipping documents.

Q10. Can you provide technical support for high-potency regulatory submissions?
A10. Yes, we offer comprehensive technical documentation and support for regulatory approvals of high-strength formulations.

Q11. How do you ensure content uniformity in high-potency manufacturing?
A11. Through advanced manufacturing technology, rigorous process validation, and enhanced quality testing protocols for high-dose formulations.

Q12. What stability testing protocols do you follow for high-potency products?
A12. ICH-guided stability protocols including accelerated and long-term condition studies with enhanced monitoring.

Q13. Do you offer PCD franchise opportunities for high-potency products?
A13. Yes, we provide exclusive franchise territories with comprehensive regulatory and marketing support.

Q14. What is your lead time for high-potency international orders?
A14. Typically 3-4 weeks from order confirmation to shipment for specialized high-strength formulations.

Q15. Are your high-potency manufacturing processes validated?
A15. Yes, all manufacturing processes undergo comprehensive validation including enhanced cleaning validation for high-potency products.

Q16. What payment terms do you offer for high-value orders?
A16. Flexible terms including LC, advance payment, and secure transaction methods tailored to client needs.

Q17. How do you manage product integrity for high-potency medications during shipping?
A17. Through advanced packaging solutions, climate-controlled logistics, and continuous environmental monitoring.

Q18. Can you supply clinical trial materials for high-dose studies?
A18. Yes, we can manufacture clinical supplies under appropriate GMP standards for high-potency research purposes.

Q19. What makes your high-potency cardiovascular manufacturing superior?
A19. Advanced technology, rigorous quality systems, extensive high-potency manufacturing experience, and competitive pricing structure.

Q20. Why choose Taj Pharma for high-potency cardiovascular medications?
A20. Technical expertise in high-potency formulations, pharmaceutical-grade quality, regulatory compliance, and reliable global supply chain establish us as the preferred international partner for advanced cardiovascular medicines.