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 200mg 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 200mg
Mexiletine Hydrochloride Capsule 200mg is a Class I antiarrhythmic medication widely used for managing documented ventricular arrhythmias, which, in the physician’s judgment, can be life-threatening. Mexiletine regulates the heartbeat by blocking abnormal electrical signals in the heart, restoring normal rhythm and minimizing risks associated with arrhythmias.
Globally, the demand for Mexiletine Hydrochloride Capsule 200mg is increasing due to:
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Rising prevalence of cardiac arrhythmias and cardiovascular disorders
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Expansion of healthcare infrastructure in emerging and developed markets
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Growing awareness among physicians and patients about safe and effective antiarrhythmic treatment
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Need for WHO-GMP-certified, high-quality antiarrhythmic capsules
Taj Pharma, a premier Mexiletine Hydrochloride Capsule 200mg manufacturer in India, is recognized worldwide for quality, purity, and reliability, catering to distributors, hospitals, and global pharmaceutical buyers.
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma ensures full compliance with international pharmaceutical standards. Buyers and importers receive:
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WHO-GMP and EU-GMP certification
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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, stability reports, and quality validation certificates
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Free Sale Certificates for international export
Custom Packaging & Labeling
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Private labeling and branding for distributors and franchises
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Multi-language packaging for global markets
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Packaging options include blister packs, strip packs, and bottles
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Compliance with international safety, transport, and regulatory standards
Shelf-Life, Storage, and Dosage Form
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Dosage Strength: 200mg
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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, dry, away from direct sunlight
Export Certifications
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WHO-GMP, 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 200mg to over 50 countries worldwide, 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 it is the Most Trusted Manufacturer/Supplier/Exporter
Taj Pharma is recognized globally as a reliable Mexiletine Hydrochloride Capsule 200mg manufacturer in India, known for quality, affordability, and timely global supply.
State-of-the-Art Manufacturing
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Advanced facility located in Vapi, Gujarat
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WHO-GMP and EU-GMP-certified production
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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 for high purity and safety
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Cost-effective, high-quality capsules for international buyers
Global Presence & Supply Chain Support
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Reliable exports to over 50 countries
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Timely delivery with secure logistics
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Assistance with regulatory approvals and market registration
Top 20 Countries Exporting
India | UAE | Saudi Arabia | Oman | Kenya | Nigeria | South Africa | Ghana | Vietnam | Myanmar | Philippines | UK | Germany | France | Brazil | Chile | Peru | Colombia | Mexico | USA
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Product Name | Mexiletine Hydrochloride Capsule 200mg |
| Dosage Form | Capsule |
| Strength | 200mg |
| Active Ingredient | Mexiletine Hydrochloride |
| Pharmacological Class | Antiarrhythmic (Class I) |
| Indications | Ventricular Arrhythmias, Life-threatening cardiac conditions |
| 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 by preventing sudden cardiac events
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Supports overall cardiovascular stability
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 operating machinery 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 in pregnancy and breastfeeding; use only if clearly needed
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Report any side effects such as dizziness, tremors, or palpitations
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Avoid abrupt discontinuation without medical guidance
PCD Pharma Franchise Opportunities with Taj Pharma
Taj Pharma offers PCD Pharma Franchise opportunities for Mexiletine Hydrochloride Capsule 200mg:
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Monopoly rights for specific regions
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Marketing support and promotional materials
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Attractive profit margins
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Access to a wide range of antiarrhythmic and cardiovascular medications
Top 20 FAQs on Mexiletine Hydrochloride Capsule 200mg
1. What is Mexiletine Hydrochloride 200mg used for?
Treats 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 to restore rhythm.
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, Taj Pharma caters to both.
10. Does Taj Pharma offer PCD franchise?
Yes, PAN India opportunities available.
11. Can it be taken with food?
Yes, but follow physician’s advice.
12. Can it cause dizziness?
Yes, avoid activities requiring focus until known.
13. What dosage strengths are available?
200mg 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






