GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains:
Acetyl leucine……………….500mg
Excipients…………………………q.s.
THERAPEUTIC INDICATIONS:
Acetylleucine is also being developed as a possible treatment for several neurological disorders.
CAUTION & WARNING:
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 Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Acetylleucine Tablets 500mg Technical Specification:
| Product Name: | Acetylleucine Tablets |
| Brand Name: | Generic |
| Strength: | 500mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Neurology, Treatment of vertigo, Central nervous system |
| Indication: | Acetylleucine is a drug that is used for symptomatic treatment of acute vestibular vertigo and dizziness. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Acetylleucine Tablets 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Acetyl leucine Tablets 500mg
Each tablet contains:
Acetyl leucine……………….500mg
Excipients…………………………q.s.
THERAPEUTIC INDICATIONS:
Acetylleucine is a modified amino acid used in the treatment of vertigo and cerebellar ataxia.
Acetylleucine is also being developed as a possible treatment for several neurological disorders.
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 Registered Medical Practitioner 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 Physician.
Introduction to Acetylleucine Tablets 500mg
Acetylleucine Tablets 500mg are widely recognized for treating dizziness (vertigo), a condition that affects millions globally. Vertigo can result from inner ear disorders, neurological conditions, or age-related vestibular dysfunction, often leading to nausea, imbalance, and impaired daily activities.
Acetylleucine works by modulating neurotransmission and stabilizing vestibular function, providing significant relief from symptoms. The global demand for Acetylleucine 500mg tablets is increasing steadily, driven by rising awareness about vestibular disorders, an aging population, and the growing need for effective, reliable treatment options.
Taj Pharma, as a trusted Acetylleucine Tablets 500mg manufacturer in India, supplies high-quality formulations adhering to international safety and efficacy standards, making it a preferred choice for distributors and healthcare providers worldwide.
Trusted Acetylleucine Tablets 500mg Manufacturer in India
Taj Pharma Ltd., Vapi, Gujarat, has established itself as a leading manufacturer, supplier, and exporter of Acetylleucine Tablets 500mg in India. Taj Pharma ensures premium-quality tablets with guaranteed purity, following WHO-GMP guidelines and stringent quality checks at every stage of production.
Therapeutic Benefits of Acetylleucine Tablets 500mg
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Relieves dizziness and vertigo symptoms
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Reduces nausea, imbalance, and motion sensitivity
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Supports vestibular system function and neurological stability
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Promotes better quality of life for patients with vertigo
The formulation is suitable for patients of all age groups suffering from acute or chronic vestibular disorders.
Details for Importers, Exporters, and Global Buyers
Taj Pharma provides comprehensive support for international buyers, ensuring smooth and compliant trade operations.
Regulatory Documentation Provided
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WHO-GMP Certification
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Certificate of Analysis (COA)
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Certificate of Pharmaceutical Product (COPP)
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Free Sale Certificate (FSC)
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Stability Data and CTD/ACTD Dossiers
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ISO Certification and Manufacturing License
Custom Packaging & Labeling
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Alu-Alu blister packs (10×10 tablets) or strip packs
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Private labeling and custom branding options
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Tamper-proof, moisture-resistant packaging
Shelf-Life, Storage, Dosage Form
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Shelf-Life: 24–36 months
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Storage: Store below 30°C, away from moisture and sunlight
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Dosage Form: Oral tablet, 500mg per tablet
Export Certifications
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WHO-GMP, EU-GMP, COPP, CTD Dossier, and other country-specific export documentation
Target Countries & Export Markets
Taj Pharma exports Acetylleucine Tablets 500mg to Africa, Middle East, Southeast Asia, Latin America, and Europe, ensuring timely delivery and compliance with local regulations.
Why is the Most Trusted Manufacturer and Exporter
1. State-of-the-Art Manufacturing
Taj Pharma operates modern WHO-GMP and ISO-certified facilities in Vapi, Gujarat, ensuring precision formulation, strict quality control, and consistent product efficacy.
2. Affordable Pricing & Quality Assurance
Optimized manufacturing processes enable competitive pricing while maintaining strict QA/QC testing to ensure purity, efficacy, and safety.
3. Global Presence & Supply Chain Support
With exports to over 40 countries, Taj Pharma provides end-to-end logistics, regulatory documentation, and support for international buyers and distributors.
4. Top 20 Countries Exporting
Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Brand Name | Taj Pharma / OEM Branding |
| Generic Name | Acetylleucine Tablets 500mg |
| Strength | 500mg |
| Dosage Form | Oral Tablet |
| Therapeutic Class | Vertigo & Dizziness Treatment |
| Composition | Acetylleucine 500mg per tablet |
| Packaging | 10×10 tablets / Alu-Alu or Strip Packs |
| Storage Conditions | Below 30°C, away from moisture & sunlight |
| Shelf Life | 24–36 months |
| Manufacturer | Taj Pharmaceuticals Ltd., India |
| Certifications | WHO-GMP, ISO, COPP, FSC, CTD Dossier |
| Export Markets | Asia, Africa, Middle East, Latin America |
Usage Guidelines and Safety
Acetylleucine Tablets 500mg should be:
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Taken with food or immediately after meals
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Taken at the same time every day for consistent effects
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Dissolved immediately if using effervescent tablets for oral solution
Common Side Effects
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Gastrointestinal issues: nausea, vomiting, abdominal pain
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Symptoms are usually mild and self-limiting
Dietary Recommendations
Fruits like bananas, citrus fruits, berries, apples, pomegranates, watermelons, and avocados are beneficial due to their potassium, vitamin C, magnesium, and antioxidants, supporting fluid balance, nerve function, and brain health to alleviate vertigo.
PCD Pharma Franchise for Acetylleucine Tablets 500mg
Taj Pharma offers PCD Pharma Franchise opportunities PAN India for distributors and entrepreneurs:
Franchise Benefits:
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Exclusive territorial rights
-
Marketing and promotional support
-
WHO-GMP certified products
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Affordable pricing and reliable supply
-
Regulatory and technical assistance
Call to Action for Buyers and Distributors
If you are seeking a trusted Acetylleucine Tablets 500mg manufacturer, supplier, or exporter in India, Taj Pharma is your ideal partner.
📞 Contact Details:
Taj Pharmaceuticals Ltd.
Corporate Office: Mumbai, Maharashtra, India
Manufacturing Unit: Vapi, Gujarat
🌐 www.tajpharma.com
✉️ info@tajpharma.com
Partner with Taj Pharma for premium-quality Acetylleucine Tablets 500mg, global supply reliability, and complete regulatory support.
Top 20 FAQs
1. What is Acetylleucine Tablets 500mg used for?
For treating vertigo and dizziness.
2. Who manufactures it in India?
Taj Pharma Ltd., Vapi, Gujarat.
3. Can it be taken long-term?
Yes, under doctor supervision.
4. What are common side effects?
Nausea, vomiting, abdominal pain (usually mild).
5. How should it be taken?
With food or immediately after meals, at the same time each day.
6. Can it be taken as an effervescent tablet?
Yes, dissolve in a glass of water and drink immediately.
7. Does diet affect vertigo symptoms?
Yes, fruits high in potassium, magnesium, and antioxidants help.
8. Is it exported globally?
Yes, Taj Pharma exports to over 40 countries.
9. What certifications does Taj Pharma hold?
WHO-GMP, ISO, COPP, FSC, CTD Dossier.
10. Is private labeling available?
Yes, custom branding and packaging are offered.
11. What is the shelf life?
24–36 months under proper storage conditions.
12. How should it be stored?
Below 30°C, away from sunlight and moisture.
13. Can it be combined with other medications?
Yes, with doctor supervision.
14. Are bulk orders accepted?
Yes, for distributors, exporters, and franchise partners.
15. Does it cause severe side effects?
Rarely; most effects are mild and temporary.
16. How quickly does it work?
Symptom improvement may be noticed within days.
17. Who should avoid it?
Patients with allergies to acetylleucine or severe gastrointestinal disorders.
18. Can it be given to elderly patients?
Yes, with monitoring of response and tolerance.
19. How does it improve vertigo?
It stabilizes vestibular function and supports nerve signaling, reducing dizziness.
20. Why choose Taj Pharma?
Premium quality, WHO-GMP certification, global supply reliability, affordable pricing, and complete regulatory support.






