Cilostazol tablets 50mg

Cilostazol tablets 50mg 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 50mg

Cilostazol Tablets 50mg represents a significant advancement in the pharmacological management of peripheral arterial disease, specifically addressing the debilitating symptoms of intermittent claudication. This unique vasodilator and antiplatelet agent offers patients improved mobility and enhanced quality of life through its dual mechanism of action.

• Pharmacological Excellence: Cilostazol functions as a selective phosphodiesterase III inhibitor, increasing cyclic adenosine monophosphate (cAMP) concentrations in platelets and blood vessels. This mechanism produces vasodilation primarily in the femoral artery bed while inhibiting platelet aggregation. The 50mg dosage provides optimal therapeutic effect for improving maximal and pain-free walking distances in patients with intermittent claudication, typically showing significant improvement within 4-12 weeks of treatment initiation.

• Therapeutic Applications: This strategic 50mg formulation serves critical roles in cardiovascular therapeutics:

  • Symptomatic treatment of intermittent claudication

  • Improvement of walking distance in peripheral artery disease

  • Reduction of leg pain and cramping during exercise

  • Adjunctive therapy in critical limb ischemia

  • Management of vasculopathic symptoms in diabetic patients

  • Secondary prevention in selected cardiovascular conditions

The international demand for Cilostazol 50mg continues to grow substantially, driven by aging populations, increasing prevalence of diabetes and cardiovascular diseases, and growing awareness of peripheral artery disease management. As a leading Cilostazol Tablets 50mg supplier, Taj Pharma addresses this essential healthcare need with precisely formulated tablets that ensure consistent 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:

• Comprehensive Certificate of Analysis with detailed 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

• 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 cardiovascular drug manufacturing processes

Packaging Options & Product Specifications

• Primary Packaging: Pharmaceutical-grade blister packs (Alu-Alu) with secure 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 cardiovascular medicine requirements

Global Export Network

3. Competitive Advantages in Cardiovascular Medicine Manufacturing

Advanced Manufacturing Infrastructure

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

• Dedicated cardiovascular drug manufacturing suites with environmental controls

• Precision granulation and compression technology

• Advanced coating systems for optimal drug delivery

• Comprehensive in-process quality control with automated monitoring

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

Enhanced Quality Assurance Protocols

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

• Content Uniformity Testing: Ensuring precise 50mg dosage accuracy across all tablets

• Dissolution Profile Testing: Verifying optimal drug release characteristics

• 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 cardiovascular medications provides:

• Temperature-controlled shipping with environmental monitoring

• Real-time shipment tracking and security protocols

• Efficient customs clearance with complete regulatory documentation

• Flexible logistics solutions for diverse market requirements

• Strict compliance with international pharmaceutical regulations

4. Technical Product Specifications

5. Contact for Partnership Opportunities

We collaborate with various stakeholders in the global healthcare ecosystem:

• International pharmaceutical distributors and wholesalers

• Government healthcare programs and public health initiatives

• Hospital networks and cardiovascular treatment facilities

• PCD Pharma Franchise partners

• Cardiology specialists and vascular medicine 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 50mg?
A1. Treatment of intermittent claudication symptoms to improve walking distance in patients with peripheral artery disease.

Q2. How long does it take to see improvement with Cilostazol?
A2. Most patients experience significant improvement in walking distance within 4-12 weeks of consistent therapy.

Q3. What dietary considerations are important with Cilostazol?
A3. Should be taken on an empty stomach, either 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.

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

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

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

Q8. Do you offer customized packaging solutions?
A8. Yes, we provide professional packaging designs tailored to specific market requirements.

Q9. What export documentation do you provide?
A9. Complete documentation including COA, CPP, stability data, and all required international shipping documents.

Q10. Can you provide technical support for regulatory submissions?
A10. Yes, we offer comprehensive technical documentation and support for regulatory approvals in target markets.

Q11. How do you ensure content uniformity in manufacturing?
A11. Through advanced manufacturing technology, rigorous process validation, and comprehensive quality testing protocols.

Q12. What stability testing protocols do you follow?
A12. ICH-guided stability protocols including accelerated and long-term condition studies.

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

Q14. What is your lead time for international orders?
A14. Typically 2-3 weeks from order confirmation to shipment for standard formulations.

Q15. Are your manufacturing processes validated?
A15. Yes, all manufacturing processes undergo comprehensive validation including cleaning validation.

Q16. What payment terms do you offer international clients?
A16. Flexible terms including LC, advance payment, and secure transaction methods.

Q17. How do you manage product quality during shipping?
A17. Through appropriate packaging solutions and environmental monitoring during transit.

Q18. Can you provide clinical trial materials?
A18. Yes, we can manufacture clinical supplies under appropriate GMP standards for research purposes.

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

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