Safinamide Tablet 100mg

Safinamide Tablets 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Safinamide Tablets 50mg
• Safinamide Tablets 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Safinamide Tablets 50mg
  Each film coated tablet contains:
  Safinamide Methane Sulphonate IP
  Equivalent to Safinamide …………………….50mg
  Excipients………………………………………………q.s.
  Colour: Fast green FCF
• Safinamide Tablets 100mg
  Each film coated tablet contains:
  Safinamide Methane Sulphonate IP
  Equivalent to Safinamide …………………….100mg
  Excipients………………………………………………q.s.
  Colour: Ponceau 4 R

THERAPEUTIC INDICATIONS:

• Safinamide is a drug used as an add-on treatment for Parkinson’s disease with “off” episodes; it has multiple modes of action, including the inhibition of monoamine oxidase B.

CAUTION & WARNING:

• CAUTION: Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
• WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A Neurologists.

STORAGE & DOSAGE:

• Storage: Store at a temperature not exceeding 30°C. Protect from Light and moisture.
• Dosage: As directed by the neurologist.

Introduction: Safinamide Tablet 100mg – A Breakthrough in Parkinson’s Disease Management

Safinamide Tablet 100mg is a highly effective medication used in combination with levodopa and carbidopa to manage Parkinson’s disease (PD) — a neurodegenerative disorder affecting millions worldwide. As a MAO-B inhibitor, Safinamide works by increasing and extending the effects of levodopa, a cornerstone therapy for Parkinson’s. By reducing “off” episodes — periods when the medication wears off and symptoms return — Safinamide Tablet 100mg helps improve motor control, mobility, and overall quality of life for patients.

The global demand for Safinamide Tablet 100mg has surged, driven by the rising prevalence of Parkinson’s disease in aging populations and the growing preference for combination therapies offering improved symptom control. Among the top producers, Taj Pharma India stands as a reputed manufacturer, supplier, and exporter of Safinamide Tablet 100mg, recognized for its commitment to high-quality, WHO-GMP-certified formulations.

Safinamide Tablet 100mg – Composition, Use, and Benefits

Each Safinamide Tablet 100mg contains Safinamide Mesylate equivalent to Safinamide 100mg. It is taken once daily, with or without food, preferably at the same time each day. Safinamide helps reduce motor fluctuations and extends the therapeutic effect of levodopa, providing a smoother and longer symptom-free period.

Key Uses of Safinamide Tablet 100mg:

• Adjunctive treatment for Parkinson’s disease with “off” episodes

• Enhances dopamine activity by inhibiting MAO-B

• Improves motor function and daily mobility

• Reduces stiffness, tremors, and slowness

• Helps maintain consistent symptom control

Common Side Effects:

• Headache

• Insomnia

• Nausea

• Hypertension

• Dyskinesia (involuntary movement)

• Drowsiness

Taj Pharma ensures each batch of Safinamide Tablet 100mg is manufactured under strict quality control to minimize adverse effects and ensure consistent efficacy.

Safinamide Tablet 100mg Manufacturer, Supplier, and Exporter

Taj Pharma, the well-known Safinamide Tablet 100mg manufacturer in India, guarantees high-quality, purity, and international standards in every product it delivers. Based in Vapi, Gujarat, Taj Pharma operates a WHO-GMP, EU-GMP-certified facility equipped with cutting-edge technology and automation for large-scale production.

As a leading pharmaceutical manufacturer and exporter, Taj Pharma caters to a wide range of global markets including Asia, Africa, Latin America, the Middle East, and Europe. The company’s commitment to excellence and compliance with international standards makes it a preferred choice for global importers, distributors, and PCD Pharma franchise partners.

Regulatory Documentation and Export Support for Global Buyers

Taj Pharma provides full regulatory, technical, and logistical support to its international partners, ensuring a smooth import process and compliance with each country’s pharmaceutical standards.

Regulatory & Technical Documentation Provided:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP and EU-GMP Certificates

• Certificate of Analysis (COA)

• Stability Data

• CTD / ACTD Dossiers

• Batch Manufacturing Records

• Free Sale Certificate

• Method of Analysis (MOA)

Packaging and Labeling Options:

Taj Pharma offers custom packaging and private labeling options tailored to client needs:

• Blister Packs / Alu-Alu / Strip Packs

• HDPE Bottles / Carton Boxes

• Customized branding with logo and market language

Shelf-Life, Storage, and Dosage Form:

• Shelf Life: 24–36 months from the date of manufacture

• Storage: Store below 25°C, in a dry place, away from sunlight

• Dosage Form: Film-coated oral tablets

Certifications and Quality Standards:

Taj Pharma adheres to globally accepted manufacturing norms:

• WHO-GMP Certified Plant

• EU-GMP Compliant

• ISO 9001:2015 Certified

• FDA-Approved Manufacturing

• Environmental and Safety Compliant

Global Export Presence – Target Markets and Reach

Taj Pharma has an extensive global footprint, with exports of Safinamide Tablet 100mg reaching over 80+ countries. The company’s international reputation is built on regulatory compliance, superior quality, and timely delivery.

Top Export Markets for Safinamide Tablet 100mg:

India | UAE | Saudi Arabia | Oman | Kenya | Nigeria | South Africa | Ghana | Vietnam | Myanmar | Philippines | UK | Germany | France | Brazil | Chile | Peru | Colombia | Mexico | USA

With strategic partnerships and robust logistics, Taj Pharma ensures efficient global distribution from India to any international destination.

Why Taj Pharma is the Most Trusted Safinamide Tablet 100mg Manufacturer & Exporter

1. State-of-the-Art Manufacturing Infrastructure

Taj Pharma’s ultra-modern facilities in Vapi, Gujarat, are equipped with automated production lines, advanced quality testing laboratories, and cleanroom environments. Each batch of Safinamide Tablet 100mg undergoes rigorous testing at every stage — from raw material sourcing to final packaging.

2. Strict Quality Assurance and Compliance

Quality assurance is central to Taj Pharma’s operations. The company follows ICH Q7, Q8, and Q9 guidelines and maintains full traceability for all products. Every Safinamide Tablet 100mg produced is compliant with WHO-GMP, FDA, and EU regulatory requirements.

3. Affordable and Competitive Pricing

Taj Pharma offers the best market price for Safinamide Tablet 100mg, ensuring affordability without compromising on efficacy or safety. Its cost-effective manufacturing and bulk production capabilities benefit global buyers and PCD Pharma franchisees.

4. Global Presence and Supply Chain Strength

With an expansive global logistics network, Taj Pharma ensures on-time delivery to every corner of the world. Dedicated export managers oversee each shipment to guarantee smooth customs clearance and regulatory adherence.

5. Customer-Centric Approach

Taj Pharma maintains long-term relationships with clients by offering end-to-end assistance — from regulatory submission to brand registration and supply continuity.

Technical Product Specification 

• Safinamide Tablet 100mg PAN India Manufacturer

• Safinamide Tablet 100mg Manufacturer Supplier and PCD Pharma Franchise

• Safinamide Tablet 100mg Manufacturer from Mumbai & Vapi, Gujarat

• Safinamide Tablet 100mg Best Price in Mumbai, Maharashtra – Taj Pharma

• Safinamide Tablet 100mg Manufacturers PAN India, Suppliers, Exporters

• Leading #1 Safinamide Tablet 100mg Manufacturer & Supplier in India

If you’re a pharmaceutical importer, distributor, or healthcare franchise owner, now is the time to partner with Taj Pharma India, the #1 Safinamide Tablet 100mg manufacturer and exporter.
With WHO-GMP-certified production, proven export track record, and competitive pricing, Taj Pharma is your trusted source for high-quality Parkinson’s disease medication.

📞 Contact Taj Pharma Today:
Email: info@tajpharma.com
Website: www.tajpharma.com
Location: Vapi, Gujarat, India

Top 20 FAQs 

1. What is Safinamide Tablet 100mg used for?
It is used with levodopa/carbidopa to treat Parkinson’s disease, improving movement and reducing “off” episodes.

2. How does Safinamide work?
It inhibits monoamine oxidase-B (MAO-B), increasing dopamine levels and prolonging the effect of levodopa.

3. Is Safinamide safe for long-term use?
Yes, when used under medical supervision. Regular monitoring is advised.

4. Who manufactures Safinamide Tablet 100mg in India?
Taj Pharma Ltd., Vapi, Gujarat, is a leading Safinamide Tablet 100mg manufacturer in India.

5. What certifications does Taj Pharma have?
WHO-GMP, EU-GMP, ISO 9001:2015, and COPP approvals.

6. Can Taj Pharma provide export documentation?
Yes, including COA, COPP, and CTD dossiers.

7. Does Taj Pharma offer private labeling?
Yes, customized branding and labeling are available for international buyers.

8. What is the shelf life of Safinamide Tablet 100mg?
Typically 24–36 months.

9. Is Taj Pharma a WHO-GMP manufacturer in India?
Yes, fully certified under WHO-GMP and EU-GMP norms.

10. What are the storage conditions?
Store below 25°C, away from light and moisture.

11. Does Taj Pharma export globally?
Yes, to over 80 countries across Africa, Asia, and Latin America.

12. What is the standard packaging?
Blister or Alu-Alu packs, customizable as per market needs.

13. Are samples available for regulatory filing?
Yes, Taj Pharma provides product samples and documentation.

14. Can it be combined with other anti-Parkinson’s drugs?
Yes, primarily used alongside levodopa/carbidopa.

15. What are common side effects?
Dyskinesia, nausea, headache, and sleep disturbance.

16. Is Taj Pharma open to PCD franchise inquiries?
Absolutely. Taj Pharma supports PAN India and global franchises.

17. What is the minimum export order quantity?
MOQ depends on the target country and regulatory requirements.

18. How is pricing determined?
Based on volume, packaging, and documentation requirements.

19. How soon can orders be shipped?
Within 2–4 weeks post regulatory clearance and payment.

20. Why choose Taj Pharma for Safinamide Tablet 100mg?
For unmatched quality, WHO-GMP compliance, and global trust built over decades.