Miltefosine 50mg Capsules

Miltefosine 50mg Capsules Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Miltefosine 50mg Capsules

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Miltefosine 50mg Capsules
   Each Hard Gelatin capsule contains:
   Miltefosine.………………50mg
   Excipients………………………………………..q.s.

THERAPEUTIC INDICATIONS:

to treat Leishmaniasis, a parasitic disease, specifically Visceral Leishmaniasis (Kala-azar) and both Cutaneous (skin) and Mucosal (nose/throat) forms caused by Leishmania species

CAUTION & WARNING:

CAUTION: (strict contraception needed for 5 months after) due to fetal harm, and fertility impairment (reversible in males but persistent in some).

WARNING: if you are pregnant, suspect you are pregnant, or are trying to become pregnant. It is known to cause death and birth defects in the fetus based on animal studies.

STORAGE & DOSAGE:

STORAGE:   store in a cool , dry & dark place . Do not store in Bathroom.

Dosage: As Directed  By the Physician.

Introduction to Miltefosine 50mg Capsules

Miltefosine 50mg Capsules are a globally recognized oral antileishmanial medicine primarily used in the treatment of kala-azar (visceral leishmaniasis), a life-threatening parasitic disease prevalent in parts of Asia, Africa, and Latin America. As one of the first effective oral therapies for kala-azar, Miltefosine has transformed disease management by offering a convenient, non-injectable alternative with proven efficacy.

With increasing global health initiatives, WHO programs, and government-backed eradication campaigns targeting leishmaniasis, the international demand for Miltefosine 50mg Capsules manufacturer in India has grown steadily. Buyers worldwide seek reliable, WHO-GMP–certified suppliers capable of delivering consistent quality, regulatory compliance, and cost-effective pricing.

Taj Pharma, a well-known Miltefosine 50mg Capsules Manufacturer Supplier in India, assures high quality, purity, safety, and global regulatory compliance, making it the preferred partner for importers, NGOs, hospitals, and public health procurement agencies.

About Miltefosine 50mg Capsules

Miltefosine 50mg Capsules belong to the class of drugs known as antimicrobial agents. They are specifically formulated to treat kala-azar by targeting the causative parasite Leishmania donovani.

Taj Pharma is a well-established Manufacturer, Exporter and Supplier of Miltefosine 50mg Capsules from Vapi, Gujarat, India, supplying both domestic PAN India markets and international buyers.

Mechanism of Action

Miltefosine interacts with essential proteins and biochemical pathways required for the growth and survival of the parasite. By disrupting cell membrane integrity and intracellular signaling, it ultimately causes parasite death, leading to clinical recovery.

Therapeutic Uses of Miltefosine 50mg Capsules

• Visceral leishmaniasis (kala-azar)

• Certain forms of cutaneous leishmaniasis (as prescribed)

• WHO-recommended oral therapy in endemic regions

As a trusted Miltefosine 50mg Capsules Manufacturer in India, Taj Pharma ensures optimal formulation, bioavailability, and therapeutic reliability.

Safety Profile & Side Effects

Taj Pharma Ltd India, a well-recognized Miltefosine 50mg Capsules Manufacturer Supplier in India, manufactures medicines under stringent quality controls to ensure patient safety.

Common Side Effects

Most side effects do not require medical attention and resolve as the body adjusts to the medicine. However, consult a doctor if symptoms persist.

• Headache

• Nausea

• Itching

• Sleepiness

• Decreased appetite

• Abdominal pain

• Diarrhea

• Vomiting

• Dizziness

• Weakness

• Motion sickness

• General discomfort

• Fever

• Lymphangitis

Important Usage Guidelines

• Take Miltefosine with food to avoid stomach upset.

• Do not skip doses and complete the full treatment course even if symptoms improve.

• It may cause dehydration—drink plenty of fluids.

• Inform your doctor if abdominal pain, nausea, or diarrhea occurs.

In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

As a reliable Miltefosine 50mg Capsules Supplier and Exporter from India, Taj Pharma offers comprehensive regulatory support:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certification

• EU-GMP (subject to requirement)

• CTD / ACTD Dossiers

• Certificate of Analysis (COA)

• Stability Studies & Data

• Free Sale Certificate (FSC)

Custom Packaging & Labeling

• HDPE bottles and blister packs

• Export-compliant secondary packaging

• Multilingual labels as per importing country regulations

• Private labeling & NGO/government tender support

• PCD Pharma Franchise customization

Shelf-Life, Storage & Dosage Form

• Dosage Form: Capsules

• Strength: 50mg

• Shelf Life: 24–36 months

• Storage: Store below 25°C, protected from moisture and light

Export Certifications

• WHO-GMP Manufacturer India

• ISO Certified Facilities

• Pharmacovigilance compliance

• Batch traceability & documentation support

Target Export Markets

Taj Pharma exports Miltefosine 50mg Capsules to:

• Africa (Sudan, Ethiopia, Kenya, Nigeria)

• South Asia (India, Bangladesh, Nepal)

• Southeast Asia

• Latin America

• Middle East

• CIS Countries

Why Taj Pharma is the Most Trusted Manufacturer & Exporter

State-of-the-Art Manufacturing

Taj Pharma operates WHO-GMP–certified manufacturing facilities in Vapi, Gujarat, equipped with advanced technology, validated processes, and strict quality assurance systems.

Affordable Pricing & Quality Assurance

As a Leading #1 Miltefosine 50mg Capsules Manufacturer & Supplier in India, Taj Pharma offers:

• Competitive export pricing

• Bulk manufacturing capacity

• International quality benchmarks

Global Presence & Supply Chain Support

• Reliable logistics & shipping partners

• On-time delivery schedules

• Support for NGOs, WHO programs & government tenders

Top 20 Exporting Countries

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

Technical Product Specification Table

PAN India & Mumbai Market Presence

• Miltefosine 50mg Capsules PAN India Manufacturer

• Miltefosine 50mg Capsules Manufacturer from Mumbai

• Best Price in Mumbai, Maharashtra – Taj Pharma

• Miltefosine 50mg Capsules Manufacturer Vapi, Gujarat

• Miltefosine 50mg Capsules PCD Pharma Franchise / Manufacturer and Supplier

Call to Action 

If you are searching for a Miltefosine 50mg Capsules Manufacturer Supplier and Exporter from India, Taj Pharma is your trusted global partner. Contact Taj Pharma today for bulk orders, export inquiries, NGO supplies, government tenders, and PCD pharma franchise opportunities.

Frequently Asked Questions (FAQs) – Miltefosine 50mg Capsules

1. What is Miltefosine 50mg Capsules used for?

Miltefosine 50mg Capsules are used for the treatment of Leishmaniasis, a parasitic infection caused by Leishmania species, including Visceral Leishmaniasis (Kala-azar), Cutaneous, and Mucosal Leishmaniasis, as prescribed by a physician.

2. Is Miltefosine an oral medicine?

Yes. Miltefosine is administered orally in capsule form, making it one of the first effective non-injectable therapies for leishmaniasis.

3. Who can take Miltefosine 50mg Capsules?

Miltefosine is indicated for adults and children aged 12 years and above, weighing 30 kg or more, strictly under medical supervision.

4. Should Miltefosine be taken with food?

Yes. It is recommended to take Miltefosine with food to minimize gastrointestinal side effects such as nausea or vomiting.

5. Is Miltefosine safe when used correctly?

Yes. Miltefosine is safe and effective when taken exactly as prescribed by a qualified healthcare professional. Regular monitoring may be advised during therapy.

6. What are the common side effects of Miltefosine?

Common side effects may include nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, weakness, and decreased appetite. Most effects are mild and resolve with continued treatment.

7. Is Miltefosine safe during pregnancy?

No. Miltefosine is contraindicated during pregnancy due to the risk of fetal harm. Strict contraception is required during treatment and for at least 5 months after therapy completion.

8. Can doses of Miltefosine be skipped?

No. Skipping doses is not recommended. Patients should complete the full prescribed course to ensure effective treatment and prevent resistance.

9. Does Miltefosine cause dehydration?

Yes, it may cause dehydration in some patients. Adequate fluid intake is strongly advised during treatment.

10. What is the recommended storage condition for Miltefosine Capsules?

Miltefosine Capsules should be stored in a cool, dry, and dark place, below 25°C, protected from moisture and direct sunlight. Do not store in bathrooms.

11. What is the shelf life of Miltefosine 50mg Capsules?

The typical shelf life is 24 to 36 months, depending on packaging and storage conditions.

12. Is Miltefosine a prescription medicine?

Yes. Miltefosine is classified as a Schedule H prescription drug and must be used only under medical supervision.

13. Is Miltefosine recommended by WHO?

Yes. Miltefosine is WHO-recommended for the treatment of leishmaniasis in endemic regions as part of national and global disease control programs.

14. Is Taj Pharma a WHO-GMP certified manufacturer?

Yes. Taj Pharma is a WHO-GMP certified manufacturer, ensuring global quality, safety, and regulatory compliance.

15. Does Taj Pharma provide regulatory documentation?

Yes. Taj Pharma provides complete documentation including COPP, COA, Stability Studies, CTD/ACTD Dossiers, FSC, and GMP certificates.

16. Does Taj Pharma offer private labeling and custom packaging?

Yes. Taj Pharma offers private labeling, customized packaging, multilingual labels, and NGO/government tender support.

17. Is Miltefosine available for bulk and institutional supply?

Yes. Taj Pharma has large-scale manufacturing capacity to support bulk orders, hospitals, NGOs, and government procurement agencies.

18. Does Taj Pharma export Miltefosine internationally?

Yes. Taj Pharma exports Miltefosine 50mg Capsules to Africa, Asia, Latin America, the Middle East, and CIS countries.

19. Can NGOs and public health programs source Miltefosine from Taj Pharma?

Yes. Taj Pharma actively supports NGOs, WHO programs, and government eradication initiatives worldwide.

20. Why choose Taj Pharma for Miltefosine 50mg Capsules?

Taj Pharma offers WHO-GMP quality, regulatory reliability, competitive pricing, bulk supply capability, and global export expertise, making it a trusted partner worldwide.

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