Mefloquine Hydrochloride Tablets USP 250mg Technical Specification:
| Product Name: | Mefloquine Hydrochloride Tablets USP |
| Brand Name: | Generic |
| Strength: | 250mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 4’s , 10’s , 30’s 100’s and 500’s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antimalarial |
| Indication: | Mefloquine Hydrochloride is an antimalarial medicine. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Mefloquine Hydrochloride Tablets USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Each film coated tablet contains:
Mefloquine Hydrochloride USP
Equivalent to Mefloquine……………………250mg
Excipients…………………………………………. q.s.
Colour: Titanium Dioxide USP.
THERAPEUTIC INDICATIONS:
Mefloquine is a medication used to prevent or treat malaria. When used for prevention it is typically started before potential exposure and continued for several weeks after potential exposure.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Warning: May cause dizziness or disturbed sense of blance. If affected do not drive or operate machinery.Mefloquine may cause neuropsychiartic adverse reactions that can persist after mefloquine has been discontinued.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Physician.
Introduction to Mefloquine Hydrochloride Tablets USP 250mg
Mefloquine Hydrochloride Tablets USP 250mg are prescription antimalarial tablets containing mefloquine hydrochloride. Mefloquine is an established antimalarial medicine that may be used for the treatment or prevention of malaria in circumstances where its use is appropriate under current clinical guidelines and approved prescribing information.
Taj Pharma serves pharmaceutical buyers seeking a Mefloquine Hydrochloride Tablets USP 250mg Manufacturer in India, supplier, and exporter. From Vapi, Gujarat, India, Taj Pharma supports qualified importers, pharmaceutical distributors, wholesalers, institutional procurement organizations, healthcare supply companies, and other international buyers.
Malaria remains an important infectious disease in many tropical and subtropical regions. Consequently, reliable access to quality-assured antimalarial medicines remains important to healthcare systems and pharmaceutical supply chains.
The choice of antimalarial medicine depends on numerous factors, including the geographical area, parasite species, local drug-resistance patterns, patient characteristics, previous medicines, contraindications, and applicable national or international treatment recommendations.
For global procurement organizations, selecting the right Mefloquine Hydrochloride Tablets USP 250mg Supplier involves much more than comparing prices. Product quality, manufacturing controls, regulatory documentation, stability, packaging, labeling, supply continuity, and export capability are equally important.
What Are Mefloquine Hydrochloride Tablets USP 250mg?
Mefloquine is an antimalarial medicine with activity against susceptible malaria parasites. Products containing mefloquine hydrochloride are prescription medicines and should be used only according to qualified medical advice and the approved product information.
The precise relationship between a labeled amount of mefloquine hydrochloride and mefloquine base depends on how the individual product specification expresses strength. Therefore, buyers should confirm the exact salt/base equivalence from the approved product specification and labeling rather than assuming that all products use identical strength conventions.
Mefloquine can be used in certain circumstances for malaria treatment and prophylaxis. However, it is not suitable for every patient or every geographical region.
Medical professionals must consider current malaria resistance information and important contraindications, particularly the medicine’s neurological and psychiatric safety profile.
How Does Mefloquine Work Against Malaria?
Mefloquine acts against susceptible malaria parasites during the blood stage of infection. Its antimalarial activity involves disruption of essential parasite processes, although its complete molecular mechanism is complex.
Malaria parasites invade red blood cells during part of their life cycle. Antimalarial medicines such as mefloquine interfere with parasite survival and multiplication, helping control susceptible infections.
The simplified statement that mefloquine merely “increases haeme in the blood” does not adequately describe its pharmacology and should not be used as the sole scientific explanation on professional product literature.
Importantly, drug resistance varies geographically. Mefloquine should therefore only be selected when appropriate for the relevant malaria region and according to current clinical recommendations.
Uses of Mefloquine Hydrochloride Tablets USP 250mg
Depending on the approved product labeling and current clinical guidance, Mefloquine Hydrochloride Tablets USP 250mg may be indicated for malaria treatment and/or prevention.
Its suitability depends upon the patient’s medical history, travel destination, local resistance patterns, age or weight requirements, concurrent medicines, and other clinical factors.
Malaria can become a serious or life-threatening illness. Suspected malaria requires prompt medical evaluation rather than self-treatment.
Similarly, travelers requiring malaria prophylaxis should obtain professional advice before travel so that the appropriate antimalarial medicine and mosquito-prevention measures can be selected.
Important Safety Information About Mefloquine
Mefloquine requires particular attention because it has been associated with neuropsychiatric and neurological adverse reactions.
Depending upon applicable prescribing information, reported adverse effects can include dizziness, headache, nausea, vomiting, abdominal discomfort, diarrhea, sleep disturbance, abnormal or vivid dreams, insomnia, vertigo, balance problems, anxiety, mood changes, and other neurological or psychiatric effects.
Some reactions may require prompt medical assessment and discontinuation or replacement of the medicine according to professional medical guidance.
Patients with certain psychiatric histories, seizure disorders, cardiac conditions, or other contraindications may not be suitable candidates for mefloquine.
Consequently, Mefloquine Hydrochloride Tablets USP 250mg must be supplied and used as a prescription medicine under appropriate medical supervision.
Administration Considerations
Mefloquine should be taken exactly as directed by the prescribing healthcare professional and according to the approved product information.
Where recommended by the applicable prescribing information, taking mefloquine with food and sufficient water may improve gastrointestinal tolerability.
For malaria treatment, patients should follow the complete prescribed regimen. A patient should not independently reduce, increase, repeat, or discontinue an antimalarial regimen.
For malaria prophylaxis, administration schedules are different from treatment schedules and may begin before entering a malaria-risk area and continue during and after exposure. The exact schedule should be determined by current authoritative guidance and a qualified healthcare professional.
Malaria Prevention Requires More Than Medication
Antimalarial prophylaxis does not replace mosquito-bite prevention.
Travelers and residents in malaria-risk regions should use appropriate measures to reduce mosquito exposure. Depending on local recommendations, these may include wearing long-sleeved or appropriately protective clothing, using effective insect repellents, sleeping under suitable insecticide-treated mosquito nets, and staying in screened or air-conditioned accommodation where practical.
Mosquito exposure can occur at different times depending upon the mosquito species and region, so travelers should follow current destination-specific public-health recommendations.
Any fever or malaria-like illness during or after travel to a malaria-endemic region requires prompt medical assessment.
Mefloquine Hydrochloride Tablets USP 250mg Manufacturer in India
India is one of the world’s major pharmaceutical manufacturing and sourcing centers, supplying medicines to domestic and international healthcare markets.
Taj Pharma supports customers seeking a Mefloquine Hydrochloride Tablets USP 250mg Manufacturer in India with an export-oriented approach covering pharmaceutical supply, commercial documentation, packaging discussions, regulatory coordination, and international logistics.
For importers, choosing an appropriate pharmaceutical supplier requires careful qualification.
The evaluation should consider the manufacturing facility, quality-management system, regulatory status, batch-testing procedures, analytical capabilities, stability documentation, packaging systems, supply reliability, and previous export experience.
Taj Pharma works with qualified business partners to understand these requirements before commercial supply.
Technical Product Specification
| Product Parameter | Specification / Information |
|---|---|
| Product Name | Mefloquine Hydrochloride Tablets USP 250mg |
| Active Ingredient | Mefloquine Hydrochloride |
| Strength | 250mg, subject to approved salt/base expression |
| Dosage Form | Tablet |
| Therapeutic Category | Antimalarial |
| Route of Administration | Oral |
| Prescription Status | Prescription Medicine |
| Pharmacological Category | Antimalarial Agent |
| Pharmacopoeial Standard | USP, where supported by approved specification |
| Packaging | Buyer/market-specific configuration subject to approval |
| Labeling | Customized options subject to regulatory requirements |
| Shelf Life | According to validated stability data and approved specification |
| Storage | According to approved product labeling |
| Manufacturing/Supply Origin | India |
| Supplier/Exporter | Taj Pharma |
| Certificate of Analysis | Batch-specific, as applicable |
| Regulatory Documentation | Subject to product and destination-market requirements |
| Dossier Support | Subject to availability and agreed project scope |
| MOQ | According to commercial and packaging requirements |
| Export Supply | Subject to destination-country registration and import regulations |
Technical disclaimer: The final composition, salt/base equivalence, excipients, appearance, dissolution specification, assay, impurities, packaging, shelf life, storage conditions, and other specifications must be confirmed from the current approved product specification, Certificate of Analysis, dossier, and applicable registration documentation.
Pharmaceutical Manufacturing and Quality Assurance
Quality assurance begins long before a finished tablet reaches the packaging line.
Pharmaceutical manufacturing requires appropriate controls covering raw-material qualification, dispensing, manufacturing, in-process testing, analytical testing, packaging, labeling, storage, documentation, and batch release.
Taj Pharma emphasizes quality-focused pharmaceutical sourcing and manufacturing support for customers seeking Mefloquine Hydrochloride Tablets USP 250mg from India.
For international procurement, buyers should request the documents necessary to conduct supplier qualification and verify the regulatory standing of the actual manufacturing facility involved in their order.
Regulatory Documentation for Importers
Every pharmaceutical destination market has its own registration and import requirements.
Depending upon the country and product, international buyers may require documents such as a Certificate of Analysis, product specification, manufacturing license, GMP documentation, stability information, manufacturing process information, analytical methods, packaging specifications, Free Sale documentation, COPP where applicable, and dossier materials.
Taj Pharma can discuss documentation requirements with qualified importers according to the destination country and proposed supply arrangement.
Buyers should submit a detailed regulatory checklist early in the procurement process. This makes it possible to establish which documents are available and which may require additional preparation.
WHO-GMP Manufacturer India – Understanding Certification Requirements
International buyers frequently search for a WHO-GMP manufacturer India when sourcing antimalarial products.
However, regulatory terminology should always be used accurately.
GMP certification relates to a particular manufacturing facility and defined scope. Therefore, buyers should request the current certificate applicable to the actual facility manufacturing the proposed product.
The existence of a general company profile or export activity should never be treated as automatic proof that every product or facility carries a particular certification.
Taj Pharma recommends verification of current documentation as part of buyer due diligence.
EU-GMP, COPP and CTD Dossier Support
Importers may request EU-GMP documentation, Certificate of Pharmaceutical Product (COPP), CTD dossier, stability data, Free Sale Certificate, or other regulatory documentation.
Availability depends upon the specific product, manufacturing facility, registration status, issuing authority, and target market.
EU-GMP status in particular should only be claimed when a current and applicable certificate or regulatory database record supports the manufacturing facility and scope concerned.
Similarly, COPP and CTD documentation should be confirmed specifically for Mefloquine Hydrochloride Tablets USP 250mg before being included in registration planning.
This transparent approach protects buyers and helps avoid unnecessary regulatory delays.
CTD Dossier for Mefloquine Hydrochloride Tablets USP 250mg
The Common Technical Document structure is widely used for pharmaceutical registration, although specific national requirements vary.
A quality dossier may include information about the active pharmaceutical ingredient, finished-product formulation, manufacturing process, controls of critical steps, finished-product specifications, analytical procedures, validation, container-closure systems, and stability.
Taj Pharma can discuss available dossier documentation with international customers seeking Mefloquine Hydrochloride Tablets USP 250mg export from India.
Buyers should provide the latest destination-country registration checklist so documentation can be evaluated against local requirements.
Customized Packaging and Labeling
Pharmaceutical packaging serves several functions: protecting product quality, supporting traceability, communicating safety information, and complying with regulatory requirements.
International buyers may require different blister configurations, bottle packs, carton sizes, pack quantities, languages, barcodes, artwork, package inserts, distributor information, or serialization elements.
Taj Pharma can discuss customized packaging and private-label solutions for eligible commercial orders.
All final artwork and labeling must conform to the approved registration and destination-country regulations before commercial production.
Shelf Life and Storage
Shelf life should never be assumed from another manufacturer’s mefloquine product.
The shelf life of Mefloquine Hydrochloride Tablets USP 250mg must be established through appropriate stability data for the specific formulation, manufacturing process, and packaging configuration.
This is particularly important for tropical export markets, where climatic conditions may affect pharmaceutical stability requirements.
Importers should request current shelf-life and storage information directly from the approved product specification.
Products should then be transported and stored according to the conditions stated on the authorized labeling.
Affordable Pricing and Quality-Focused Supply
Global pharmaceutical buyers need commercially sustainable pricing, but price alone should never determine the selection of an antimalarial medicine supplier.
The overall procurement value includes manufacturing quality, batch consistency, documentation, regulatory support, packaging, remaining shelf life, supply reliability, and export logistics.
Taj Pharma works to provide commercially competitive solutions for qualified buyers seeking Mefloquine Hydrochloride Tablets USP 250mg Supplier services.
Pricing depends on order quantity, pack configuration, artwork, documentation requirements, destination, shipment terms, production planning, and current input costs.
Buyers should request a current quotation rather than relying on historical pricing.
Global Pharmaceutical Supply Chain Support
Reliable international pharmaceutical supply requires coordination between production, quality assurance, regulatory affairs, commercial teams, logistics providers, customs agents, and destination-country importers.
Taj Pharma supports export-oriented transactions by coordinating commercial and product documentation according to agreed requirements.
For an accurate quotation, buyers should provide the required quantity, annual forecast, pack size, destination country, registration status, regulatory-document checklist, shipping destination, and preferred Incoterms.
Complete information can help shorten the procurement cycle and reduce avoidable delays.
Top 20 Target Countries and Export Markets
Demand for antimalarial medicines is particularly relevant in regions where malaria transmission remains a public-health concern, although the suitability of mefloquine varies because of resistance patterns and national treatment policies.
Potential pharmaceutical sourcing markets may include:
Nigeria, Ghana, Kenya, Tanzania, Uganda, Ethiopia, Zambia, Zimbabwe, Mozambique, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Angola, South Africa, Bangladesh, Myanmar, Cambodia, Vietnam, Philippines, and Papua New Guinea.
These countries are listed as potential pharmaceutical markets only. The list does not mean Taj Pharma’s Mefloquine Hydrochloride Tablets USP 250mg are currently registered, approved, recommended, or exported in every listed country.
Furthermore, mefloquine resistance and malaria-treatment policies vary geographically. Buyers must consult current national malaria guidelines and regulatory requirements before registration or procurement.
Mefloquine Hydrochloride Tablets USP 250mg PAN India Manufacturer
Taj Pharma supports domestic and international buyers searching for Mefloquine Hydrochloride Tablets USP 250mg PAN India Manufacturer, Mefloquine Hydrochloride Tablets USP 250mg Manufacturer & Supplier, and Mefloquine Hydrochloride Tablets USP 250mg Manufacturers India Suppliers Exporters.
Business inquiries can be evaluated according to required quantities, distribution territory, packaging, regulatory documentation, and commercial requirements.
Mefloquine Hydrochloride Tablets USP 250mg Manufacturer in Mumbai
Organizations searching online for a Mefloquine Hydrochloride Tablets USP 250mg Manufacturer from Mumbai or Mefloquine Hydrochloride Tablets USP 250mg in Mumbai, Maharashtra | Taj Pharma can contact Taj Pharma regarding commercial supply.
Where the actual manufacturing facility is located outside Mumbai, marketing materials should distinguish accurately between the company’s commercial presence and the manufacturing site’s physical location.
This is particularly important for pharmaceutical regulatory documentation.
Mefloquine Hydrochloride Tablets USP 250mg Manufacturer Vapi, Gujarat
Vapi and Gujarat are important locations within India’s pharmaceutical and chemical manufacturing ecosystem.
Taj Pharma supports customers seeking a Mefloquine Hydrochloride Tablets USP 250mg Manufacturer, Supplier in Vapi, Gujarat and pharmaceutical export solutions from India.
International buyers can submit their specifications and regulatory requirements for commercial evaluation.
PCD Pharma Franchise and Distribution Opportunities
Buyers may also search for Mefloquine Hydrochloride Tablets USP 250mg Manufacturer Supplier and PCD Pharma Franchise opportunities.
Taj Pharma can discuss eligible distribution, private-label, institutional supply, or franchise arrangements depending upon product availability, territory, trademark considerations, regulatory permissions, minimum order quantities, and existing commercial agreements.
Prescription antimalarial medicines must only be marketed and distributed through appropriately authorized channels.
Why Global Buyers Consider Taj Pharma
Taj Pharma’s export-focused pharmaceutical approach combines product sourcing and manufacturing capability with quality assurance, documentation coordination, packaging discussions, commercial support, and international supply planning.
For buyers searching for a Mefloquine Hydrochloride Tablets USP 250mg Manufacturer in India, the objective is to provide an organized B2B procurement process.
Qualified importers can discuss specifications, registration documentation, pack configuration, pricing, order quantity, production lead time, shipping, and ongoing supply requirements with Taj Pharma.
Call to Action – Contact Taj Pharma for Mefloquine Hydrochloride Tablets USP 250mg
Are you a pharmaceutical importer, distributor, wholesaler, institutional procurement organization, healthcare supplier, government tender participant, or international pharmaceutical company looking for Mefloquine Hydrochloride Tablets USP 250mg from India?
Contact Taj Pharma with your complete procurement requirements.
Include your destination country, required quantity, annual forecast, pack size, registration status, documentation checklist, labeling requirements, preferred shipping terms, and destination port.
Qualified buyers can request current product specifications, Certificate of Analysis information, commercial quotation, MOQ, packaging options, dossier availability, applicable manufacturing credentials, shelf-life information, lead time, and export terms.
Top 20 FAQs About Mefloquine Hydrochloride Tablets USP 250mg
1. What are Mefloquine Hydrochloride Tablets USP 250mg?
They are prescription antimalarial tablets containing mefloquine hydrochloride. Their approved indications and exact strength expression should be confirmed from the applicable product labeling.
2. What is mefloquine used for?
Mefloquine may be used for the treatment or prevention of malaria in appropriate circumstances, depending on current guidelines, resistance patterns, patient characteristics, and approved indications.
3. Is mefloquine an antimalarial medicine?
Yes. Mefloquine is an antimalarial medication active against susceptible malaria parasites.
4. Can Mefloquine Hydrochloride Tablets USP 250mg prevent malaria?
Mefloquine can be used for malaria prophylaxis in appropriate travelers and geographical areas when recommended by a qualified healthcare professional.
5. Can mefloquine treat all types of malaria?
No. Treatment selection depends on parasite species, disease severity, geographic resistance patterns, and current clinical guidelines.
6. What are common side effects of mefloquine?
Reported effects include nausea, vomiting, abdominal discomfort, diarrhea, headache, dizziness, sleep disturbances, abnormal dreams, insomnia, vertigo, and balance problems.
7. Does mefloquine have psychiatric side effects?
Mefloquine has important neuropsychiatric safety warnings. Patients experiencing significant psychiatric or neurological symptoms should obtain prompt medical advice.
8. Can everyone take mefloquine?
No. Mefloquine may be unsuitable for patients with certain psychiatric, neurological, cardiac, or other medical conditions. Medical assessment is necessary.
9. Should Mefloquine Hydrochloride Tablets USP 250mg be taken with food?
Patients should follow their approved product instructions. Mefloquine is commonly administered with food and sufficient water where specified by the prescribing information.
10. Is Mefloquine Hydrochloride Tablets USP 250mg prescription-only?
Yes, mefloquine should be used under appropriate medical supervision and according to applicable national prescription requirements.
11. Does Taj Pharma supply Mefloquine Hydrochloride Tablets USP 250mg?
Taj Pharma accepts qualified B2B inquiries concerning Mefloquine Hydrochloride Tablets USP 250mg manufacturing and supply from India, subject to applicable regulatory requirements.
12. Can Taj Pharma export Mefloquine Hydrochloride Tablets USP 250mg?
International supply can be discussed subject to product registration, importing-country regulations, documentation, and commercial feasibility.
13. Is customized packaging available?
Customized packaging may be discussed according to commercial quantities, technical feasibility, approved product specifications, and destination-country regulations.
14. Does Taj Pharma offer private labeling?
Private-label opportunities can be evaluated for qualified buyers subject to regulatory, trademark, manufacturing, and commercial requirements.
15. Is a CTD dossier available?
Dossier availability must be confirmed for the specific product and market. Buyers should submit their regulatory checklist when requesting documentation.
16. Is WHO-GMP documentation available?
Buyers should request and verify current GMP documentation applicable to the actual manufacturing facility and proposed product supply.
17. Is EU-GMP documentation available?
EU-GMP status should only be claimed where supported by current, verifiable facility-specific regulatory documentation.
18. What is the shelf life of Mefloquine Hydrochloride Tablets USP 250mg?
The applicable shelf life should be confirmed from validated stability data and the approved specification for the actual supplied product.
19. What is the MOQ for export orders?
Minimum order quantity depends on packaging, production requirements, destination, documentation, and commercial terms. Buyers should request a current quotation.
20. Why choose Taj Pharma as a Mefloquine Hydrochloride Tablets USP 250mg Supplier?
Taj Pharma offers an export-oriented pharmaceutical supply approach combining quality-focused manufacturing, regulatory-document coordination, packaging flexibility, commercial support, and international supply-chain services.
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Mefloquine Hydrochloride USP
Equivalent to Mefloquine……………………250mg
Excipients…………………………………………. q.s.
Colour: Titanium Dioxide USP.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Warning: May cause dizziness or disturbed sense of blance. If affected do not drive or operate machinery.Mefloquine may cause neuropsychiartic adverse reactions that can persist after mefloquine has been discontinued.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.

