GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Mexiletine Hydrochloride Capsule USP 150mg
C) Mexiletine Hydrochloride Capsule USP 200mg
D) Mexiletine Hydrochloride Capsule USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…...........50mg
Excipients………………………………………..q.s.
B) Mexiletine Hydrochloride Capsule USP 150mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…...........150mg
Excipients………………………………………..q.s.
C) Mexiletine Hydrochloride Capsule USP 200mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…...........200mg
Excipients………………………………………..q.s.
D) Mexiletine Hydrochloride Capsule USP 250mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…...........250mg
Excipients………………………………………..q.s.
THERAPEUTIC INDICATIONS:
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:
Dosage: As directed by the Physician
Attach dispensing label here.
Mexiletine Hydrochloride Capsule 250mg Technical Specification:
| Product Name: | Mexiletine Hydrochloride Capsule USP |
| Brand Name: | Generic |
| Strength: | 50mg, 150mg, 200mg, 250mg |
| Dosage Form: | Capsules (Hard gelatin) |
| 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: | Anti-arrhythmic |
| Indication: | Mexiletine belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm. Mexiletine produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive. Mexiletine is available only with your doctor’s prescription |
| Storage: | Store at 20° to 25°C (68° to 77°F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Mexiletine Hydrochloride Capsule USP 50mg
- Mexiletine Hydrochloride Capsule USP 150mg
- Mexiletine Hydrochloride Capsule USP 200mg
- Mexiletine Hydrochloride Capsule USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Mexiletine Hydrochloride Capsule USP 50mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…………..50mg
Excipients………………………………………..q.s. - Mexiletine Hydrochloride Capsule USP 150mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…………..150mg
Excipients………………………………………..q.s. - Mexiletine Hydrochloride Capsule USP 200mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…………..200mg
Excipients………………………………………..q.s. - Mexiletine Hydrochloride Capsule USP 250mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…………..250mg
Excipients………………………………………..q.s.
THERAPEUTIC INDICATIONS:
- Mexiletine belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm. Mexiletine produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive. Mexiletine is available only with your doctor’s prescription
CAUTION & WARNING:
- CAUTION: Dispense in well-closed containers.
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).
- Dosage: As directed by the Physician
Attach dispensing label as per end county.
Introduction to Mexiletine Hydrochloride Capsule 250mg
Mexiletine Hydrochloride Capsule 250mg is a Class I antiarrhythmic drug specifically designed for managing documented ventricular arrhythmias. Physicians prescribe it when they judge these arrhythmias as life-threatening. While Class I antiarrhythmic drugs like Mexiletine regulate abnormal heart rhythms, they have not been proven to improve survival rates in all patients with ventricular arrhythmias.
Taj Pharma, a prominent Mexiletine Hydrochloride Capsule 250mg manufacturer in India, provides global buyers with top-quality, WHO-GMP-certified capsules. Mexiletine works by blocking abnormal electrical signals in the heart, effectively controlling irregular heartbeats and minimizing potential cardiac complications.
The global demand for Mexiletine Hydrochloride Capsule 250mg is rising due to:
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Increased prevalence of cardiovascular diseases and arrhythmias
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Expansion of healthcare infrastructure worldwide
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Growing awareness among physicians and patients regarding antiarrhythmic medications
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Rising requirement for high-quality, certified medicines from trusted manufacturers
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma ensures international compliance by providing:
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WHO-GMP and EU-GMP certifications
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Certificate of Pharmaceutical Product (COPP)
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CTD/eCTD dossiers for regulatory approvals
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Batch records, quality validation certificates, and stability reports
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Free Sale Certificates (FSC) for global exports
Custom Packaging & Labeling
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Private labeling and multi-language packaging
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Blister packs, strip packs, and bottles
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Compliance with international shipping, safety, and regulatory standards
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Tailored branding solutions for PCD Pharma Franchise and distributors
Shelf-Life, Storage, and Dosage Form
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Dosage Strength: 250mg
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Dosage Form: Capsule
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Shelf-Life: 24–36 months
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Storage: Store below 25°C, in a dry place away from sunlight
Export Certifications
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WHO-GMP and EU-GMP certified
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ISO 9001:2015 compliance
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COPP and CTD dossier documentation
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Stability and quality assurance reports
Target Countries & Export Markets
Taj Pharma exports Mexiletine Hydrochloride Capsule 250mg to over 50 countries including:
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Asia: Nepal, Bangladesh, Sri Lanka, Vietnam
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Africa: Nigeria, Kenya, South Africa, Ghana
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Middle East: UAE, Saudi Arabia, Oman, Iraq
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Latin America: Peru, Colombia, Chile, Bolivia
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Europe & CIS: Russia, Kazakhstan, Uzbekistan, Kyrgyzstan
Why is the Most Trusted Manufacturer/Supplier/Exporter
Taj Pharma stands out as a leading Mexiletine Hydrochloride Capsule 250mg manufacturer in India for quality, reliability, and global reach.
State-of-the-Art Manufacturing
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Advanced production facility in Vapi, Gujarat
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WHO-GMP and EU-GMP certified
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Fully equipped R&D and quality control laboratories
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High-precision machinery ensures consistent potency and purity
Affordable Pricing & Quality Assurance
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Competitive pricing for bulk and retail orders
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Multi-step quality control ensures high purity and safety
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Cost-effective capsules without compromising quality
Global Presence & Supply Chain Support
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Exports to over 50 countries worldwide
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Reliable, timely delivery with secure logistics
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Regulatory support for market registration and approvals
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 |
|---|---|
| Product Name | Mexiletine Hydrochloride Capsule 250mg |
| Dosage Form | Capsule |
| Strength | 250mg |
| Active Ingredient | Mexiletine Hydrochloride |
| Pharmacological Class | Antiarrhythmic (Class I) |
| Indications | Life-threatening ventricular arrhythmias |
| Packaging Options | Blister / Strip Packs / Bottles |
| Storage Conditions | Store below 25°C, dry, away from sunlight |
| Shelf-life | 24–36 months |
| Certifications | WHO-GMP, EU-GMP, ISO, COPP |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
Clinical Benefits and Usage Guidelines
Clinical Benefits:
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Manages life-threatening ventricular arrhythmias
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Regulates abnormal heart rhythms
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Improves patient quality of life
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Reduces risk of sudden cardiac events
Usage Guidelines:
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Take capsules as prescribed by a cardiologist
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May be taken with or without food for optimal absorption
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Avoid driving or performing activities requiring focus until response to medication is known
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Regular monitoring of heart rhythm and blood parameters is recommended
Precautions:
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Inform your physician of any liver, kidney, or cardiac disorders
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Caution during pregnancy and breastfeeding; only use if clearly prescribed
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Report side effects like dizziness, tremors, or palpitations
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Avoid abrupt discontinuation without medical guidance
PCD Pharma Franchise Opportunities with US
Taj Pharma offers PCD Pharma Franchise opportunities for Mexiletine Hydrochloride Capsule 250mg:
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Monopoly rights for specific regions
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Marketing and promotional support
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Attractive profit margins
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Access to a wide range of cardiovascular and antiarrhythmic medications
Top 20 FAQs
1. What is Mexiletine Hydrochloride 250mg used for?
Life-threatening ventricular arrhythmias
2. Who is the manufacturer in India?
Taj Pharma, Vapi, Gujarat
3. Are these capsules WHO-GMP certified?
Yes, fully certified
4. How does Mexiletine work?
Blocks abnormal electrical signals in the heart
5. What are common side effects?
Nausea, vomiting, dizziness, tremors, chest pain, palpitations
6. Is custom packaging available?
Yes, multi-language and private labeling options
7. What is the shelf-life?
24–36 months
8. Are these capsules exported globally?
Yes, to over 50 countries
9. Can hospitals and distributors procure directly?
Yes
10. Does Taj Pharma offer PCD franchise?
Yes, PAN India opportunities available
11. Can it be taken with food?
Yes, follow physician’s advice
12. Can it cause dizziness?
Yes, avoid activities requiring focus
13. What dosage strengths are available?
250mg and other approved strengths
14. Does Taj Pharma provide bulk export solutions?
Yes, for hospitals, tenders, and distributors
15. What export certifications are provided?
WHO-GMP, EU-GMP, COPP, CTD dossiers
16. Is it safe during pregnancy?
Only if prescribed by a cardiologist
17. What are the storage requirements?
Store below 25°C, dry, away from sunlight
18. Does it require regular monitoring?
Yes, monitor heart rhythm and blood parameters
19. Can it be used for chronic arrhythmias?
Yes, under physician supervision
20. How to contact Taj Pharma?
Website: www.tajpharma.com, Email: info@tajpharma.com






