Terbinafine Tablets 500mg

Terbinafine Tablets  500mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Terbinafine Tablets IP 250mg
B) Terbinafine Tablets IP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Terbinafine Tablets IP 250mg
Each uncoated tablet contains:
Terbinafine Hydrochloride IP
Equivalent to Terbinafine…………250mg
Excipients………………………………….q.s.

B) Terbinafine Tablets IP 500mg
Each uncoated tablet contains:
Terbinafine Hydrochloride IP
Equivalent to Terbinafine………..500mg
Excipients…………………………………q.s.

THERAPEUTIC INDICATIONS:

Terbinafine is an antifungal medication used to treat pityriasis versicolor, fungal nail infections, and ringworm including jock itch and athlete’s foot.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store in a dry place at a temperature not exceeding 25°c.
Protect from Light.
Dosage: As directed by the Physician.

Introduction to Terbinafine Tablets 500mg: What It Is, Uses & Global Demand

Terbinafine Tablets 500mg are a widely prescribed antifungal medication used to treat fungal infections of the skin, hair, and nails, including onychomycosis (toenail and fingernail fungus), tinea capitis (scalp ringworm), athlete’s foot, and jock itch. The active ingredient, terbinafine hydrochloride, works by inhibiting squalene epoxidase, an essential enzyme required for fungal cell membrane synthesis, ultimately killing the fungi responsible for infections.

This powerful antifungal medication has become a first-line treatment for dermatophyte infections globally due to its high efficacy, excellent absorption, and safety profile. It is especially preferred in chronic nail infections that are difficult to treat with topical agents alone.

Why Global Demand is Growing

With the global rise in fungal infections and increasing awareness of personal hygiene, Terbinafine Tablets 500mg are witnessing significant demand growth in both regulated and semi-regulated markets. Healthcare systems worldwide are turning to reliable Indian pharmaceutical exporters like Taj Pharma for high-quality, cost-effective antifungal solutions.

Terbinafine Tablets 500mg by Taj Pharma India

Taj Pharma, a leading Terbinafine Tablets 500mg manufacturer in India, ensures premium-quality formulations that meet international quality and safety standards. Based in Vapi, Gujarat, the company is well known for its WHO-GMP-certified production and commitment to excellence.

Terbinafine Tablets 500mg are formulated to ensure optimal absorption and therapeutic efficacy while minimizing potential side effects. Taj Pharma’s manufacturing facilities follow Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), maintaining consistency in every batch exported worldwide.

Therapeutic Indications of Terbinafine Tablets 500mg

Taj Pharma’s Terbinafine Tablets 500mg are used for:

• Fungal infections of the toenails and fingernails (onychomycosis)

• Tinea capitis (scalp fungal infection)

• Tinea pedis (athlete’s foot)

• Tinea cruris (jock itch)

• Tinea corporis (ringworm)

Mechanism of Action:
Terbinafine blocks the enzyme squalene epoxidase, preventing ergosterol synthesis — a key component of the fungal cell membrane. This causes an accumulation of squalene and disruption of the fungal cell wall, resulting in fungal death.

Possible Side Effects of Terbinafine Tablets 500mg

Most patients tolerate Terbinafine well, but possible side effects include:

• Headache, rash, diarrhea, upset stomach

• Itching, taste disturbances, and mild nausea

• Rare: liver toxicity, severe skin reactions, or blood disorders

Taj Pharma ensures strict pharmacovigilance and batch testing to ensure global patients receive only safe, high-quality antifungal medication.

To Make Terbinafine Tablets 500mg Safe for Use

Before starting Terbinafine Tablets 500mg, inform your healthcare provider if you:

• Have liver or kidney issues

• Are pregnant, planning to conceive, or breastfeeding

• Take other medications (to prevent drug interactions)

Taj Pharma’s product leaflets and labeling include complete safety, dosage, and warning information compliant with global pharmacovigilance guidelines.

For Importers, Exporters, and Global Buyers: Complete Product & Regulatory Details

Regulatory Documentation Provided

Taj Pharma provides full regulatory and export documentation, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate

• Certificate of Analysis (COA)

• Stability Data

• Batch Manufacturing Record (BMR)

• Drug Master File (DMF)

• CTD / ACTD Dossiers

• Analytical Method Validation

This ensures hassle-free registration and importation in both regulated and semi-regulated markets worldwide.

Custom Packaging & Private Labeling

Taj Pharma offers customized export packaging and private-label solutions as per client requirements. Packaging formats include:

• Blister Packs (Alu-Alu or PVC/Alu)

• HDPE or PET Bottles

• Bulk Pack for Institutional Supply

• Multilingual Artwork (English, French, Spanish, Arabic, etc.)

All packs include tamper-proof seals, batch traceability, and clearly printed expiry and manufacturing details.

Shelf-Life, Storage & Dosage Form

• Shelf Life: 24–36 months

• Storage: Below 30°C, away from direct sunlight and moisture

• Dosage Form: Oral tablets (film-coated, 500mg)

• Color & Shape: White to off-white, round tablet

Export Certifications

Taj Pharma’s facilities are certified and audited by leading regulatory authorities. Major certifications include:

• WHO-GMP (World Health Organization Good Manufacturing Practice)

• EU-GMP (European Union GMP)

• ISO 9001:2015 Quality System Certification

• COPP & Free Sale Certificates

• PIC/S GMP Compliance

These accreditations position Taj Pharma as a trusted pharmaceutical exporter to over 60+ countries.

Target Countries & Export Markets for Terbinafine Tablets 500mg

Taj Pharma has a strong global presence with successful product registrations across continents:

Asia-Pacific: Philippines, Vietnam, Myanmar, Thailand, Malaysia, Sri Lanka
Middle East: UAE, Oman, Yemen, Iraq, Jordan, Saudi Arabia
Africa: Kenya, Nigeria, Ghana, Tanzania, Uganda, South Africa
Europe & CIS: Ukraine, Georgia, Armenia, Belarus, Moldova, Uzbekistan
Latin America: Peru, Chile, Ecuador, Bolivia, Dominican Republic

Each export order is backed by regulatory assistance, product dossier support, and custom logistics planning.

Why is the Most Trusted Terbinafine Tablets 500mg Manufacturer in India

Taj Pharma has earned a strong reputation for manufacturing high-quality generic pharmaceuticals with precision, consistency, and compliance.

1. State-of-the-Art Manufacturing Infrastructure

Located in Vapi, Gujarat, Taj Pharma’s facility is equipped with:

• Automated blending, granulation, and coating lines

• Advanced quality control labs

• Microbiology and stability testing units

• Dedicated R&D for process optimization

2. Quality Assurance & Global Compliance

Each batch of Terbinafine Tablets 500mg is tested as per:

• Indian Pharmacopoeia (IP)

• British Pharmacopoeia (BP)

• United States Pharmacopoeia (USP)

Taj Pharma follows ICH Q7, Q8, and Q10 standards ensuring superior consistency and quality.

3. Affordable Pricing & High Volume Capacity

As one of the largest bulk exporters of Terbinafine Tablets 500mg from India, Taj Pharma offers competitive pricing, supporting government tenders, hospital supply chains, and large distributors globally.

4. Strong Global Presence

With 60+ export destinations and partnerships with leading distributors, Taj Pharma provides seamless regulatory, logistics, and after-sales support.

Top 20 Export Countries for Terbinafine Tablets 500mg

UAE || Saudi || Arabia || Oman || Qatar || Kuwait || Nigeria || Kenya || Ghana || South Africa || Egypt || Germany || France || UK || Italy || Spain || Sri Lanka || Myanmar Malaysia || Philippines || Vietnam

Technical Product Specification: 

 Your Trusted Terbinafine Tablets 500mg Supplier

Are you a pharmaceutical importer, distributor, or procurement agency looking for a reliable WHO-GMP Terbinafine Tablets 500mg manufacturer in India?

Taj Pharma offers:

• Bulk export and private labeling

• Regulatory documentation and support

• Flexible MOQs

• Fast turnaround and global delivery

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

With over two decades of excellence, Taj Pharma continues to be a global leader in generic formulations and pharmaceutical exports trusted by distributors in 60+ nations.

Top 20 FAQs 

1. What are Terbinafine Tablets 500mg used for?
They treat fungal infections of the nails, scalp, and skin caused by dermatophytes.

2. How does Terbinafine work?
It blocks fungal cell wall synthesis by inhibiting the squalene epoxidase enzyme.

3. Who is the best manufacturer of Terbinafine Tablets 500mg in India?
Taj Pharma India Ltd, based in Vapi, Gujarat, is a leading WHO-GMP-certified manufacturer and exporter.

4. What are the common side effects?
Headache, nausea, rash, diarrhea, and taste changes.

5. Is it safe for long-term use?
Yes, under doctor supervision with periodic liver function monitoring.

6. Does Taj Pharma supply globally?
Yes, Taj Pharma exports to over 60+ countries worldwide.

7. What certifications does Taj Pharma have?
WHO-GMP, EU-GMP, ISO 9001:2015, COPP, and CTD dossiers.

8. What is the shelf life?
24 to 36 months from the date of manufacture.

9. What is the dosage form?
Film-coated oral tablets, 500mg.

10. Can it be used during pregnancy?
Consult a healthcare provider before use during pregnancy or breastfeeding.

11. What storage conditions are required?
Store below 30°C, away from light and moisture.

12. Does Taj Pharma offer private labeling?
Yes, custom branding and multilingual packaging are available.

13. Are samples available for registration?
Yes, Taj Pharma provides dossier and sample support for registration.

14. What is the MOQ for export?
Typically 50,000 tablets or as per country requirements.

15. Does Taj Pharma support dossier submissions?
Yes, with full CTD/ACTD formats for regulatory compliance.

16. What are the shipping timelines?
Exports are processed within 3–6 weeks.

17. Can Taj Pharma provide COPP and COA?
Yes, both are included in the export documentation set.

18. Are the tablets sugar-free?
Yes, available as per buyer specification.

19. Is the product compliant with ICH guidelines?
Absolutely. Stability and quality testing follow ICH Q1A standards.

20. How can buyers contact Taj Pharma?
Visit www.tajpharma.in or email info@tajpharma.com.

Taj Pharma stands as the 1 trusted Terbinafine Tablets 500mg manufacturer and exporter in India, known for its commitment to quality, affordability, and compliance.

With state-of-the-art manufacturing, global regulatory approvals, and customer-centric export services, Taj Pharma remains the preferred choice for importers and distributors worldwide seeking high-quality antifungal products backed by WHO-GMP standards.