GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Bedaquiline Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Bedaquiline 100mg Tablets
Each Uncoated Tablets contains:
Eq. to Bedaquiline……………100mg
Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Bedaquiline is used in the treatment of multi-drug resistant tuberculosis (MDR-TB). It is used in the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis.

 CAUTION & WARNING:

CAUTION:  Keep medicine out of reach of children. Keep container tightly closed
WARNING:  Don’t Crush ,chew, or dissolve Hamsen tablets since this can damage the medication and cause it to  work less well.

STORAGE & DOSAGE:

STORAGE:  Keep the medication at room temperature, away from heat, moisture, and direct light. Do not freeze.
Dosage: As Directed By The Physician.

Bedaquiline Tablets 100mg Technical Specification:

Product Name: Bedaquiline Tablets
Brand Name: (Hamsen)
Strength:  100mg
Dosage Form: Uncoated Tablets
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antitubercular agent
Indication: to treat pulmonary tuberculosis of the lungs caused by Mycobacterium tuberculosis that is resistant to other medicines (eg, rifampin, isoniazid). Bedaquiline prevents the growth of tuberculosis in the body.
Storage: Store at 20° to 25°C (68° to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Bedaquiline Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Bedaquiline 100mg Tablets
Each Uncoated Tablets contains:

Eq. to Bedaquiline……………100mg
Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Bedaquiline is used in the treatment of multi-drug resistant tuberculosis (MDR-TB). It is used in the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis.

CAUTION &  WARNING:

CAUTION:  Keep medicine out of reach of children.
Keep container tightly closed.

WARNING:  Don’t Crush ,chew, or dissolve Hamsen tablets since this can damage the medication and cause it to  work less well.

STORAGE & DOSAGE:

STORAGE:  Keep the medication at room temperature, away from heat, moisture, and direct light. Do not freeze.

Dosage: As Directed By The Physician.

1. Introduction to Bedaquiline Tablets 100mg

Bedaquiline Tablets 100mg Manufacturer in India plays a crucial role in global tuberculosis treatment supply chains due to increasing demand for advanced MDR-TB therapies. Bedaquiline Tablets 100mg is a specialized diarylquinoline antibiotic used in combination therapy for treating multidrug-resistant tuberculosis (MDR-TB) in adults and children under medical supervision.

It works by inhibiting mycobacterial ATP synthase, an essential enzyme required by tuberculosis bacteria for energy production. By blocking this mechanism, the drug effectively stops bacterial growth and supports treatment success in resistant TB cases.

Global demand for Bedaquiline has significantly increased due to rising MDR-TB cases, especially across Africa, Asia, and Latin America, making India a leading pharmaceutical manufacturing hub.


2. Medical Importance and Mechanism of Action

Taj Medico the well-known Bedaquiline Tablets 100mg Manufacturer in India gives the assurance of high-quality and purity. It is a specialized diarylquinoline antibiotic prescribed as part of combination therapy to treat pulmonary MDR-TB.

It is widely recommended in global TB programs due to its ability to target drug-resistant strains that do not respond to first-line antibiotics. Its mechanism ensures effective bacterial suppression and improved patient recovery outcomes.


3. Global Demand and Clinical Usage

Taj Medico is well established Manufacturer, Exporter and Supplier of Bedaquiline Tablets 100mg from Vapi, Gujarat India, used to treat pulmonary tuberculosis caused by Mycobacterium tuberculosis resistant to rifampin and isoniazid.

The increasing burden of TB globally has made this medicine a critical part of WHO-recommended treatment protocols. Hospitals and government health programs rely on consistent supply from trusted manufacturers.


4. Export, Importer & Buyer Requirements

For global buyers and importers, we provide complete pharmaceutical export documentation and regulatory compliance support.

Regulatory Documentation Provided

  • WHO-GMP Certificate
  • COPP (Certificate of Pharmaceutical Product)
  • CTD Dossier
  • Free Sale Certificate
  • Stability Data Reports

Custom Packaging & Labeling

  • Export-grade blister packs
  • Country-specific labeling
  • Tamper-proof packaging
  • Multilingual instructions

Shelf Life & Storage

  • Standard shelf life: 24–36 months
  • Store below 25°C
  • Protect from moisture and direct sunlight

Dosage Form

  • Oral Tablets: 100mg strength

Export Markets

  • Africa (Nigeria, Kenya, South Africa)
  • Middle East (UAE, Saudi Arabia)
  • LATAM (Brazil, Mexico, Peru)
  • Southeast Asia (Vietnam, Philippines)

5. Why Taj Medico is a Trusted Global Manufacturer

Taj Medico Ltd India is a recognized Manufacturer, Exporter and Supplier of Bedaquiline Tablets 100mg from Vapi, ensuring high-quality production standards.

Key Strengths

  • WHO-GMP certified manufacturing facility
  • Advanced formulation technology
  • Affordable bulk pricing for global buyers
  • Strong export logistics network
  • Strict quality assurance systems

Taj Medico is well known for delivering diarylquinoline antimycobacterial drugs used in combination therapy for MDR-TB treatment.


6. Safety, Usage & Clinical Guidelines

Taj Medico Ltd is Top known Manufacturer, Exporter and Supplier of Bedaquiline Tablets 100mg.

Common Side Effects

  • Muscle or joint pain
  • Headache
  • Stomach pain
  • Rash and itching
  • Dry skin
  • Sleep disturbances
  • Numbness or tingling

Medical supervision is mandatory during therapy.


7. Dosage & Administration Guidelines

Taj Medico is Best Known Manufacturer of Bedaquiline Tablets 100mg from Vapi, Gujarat India.

  • Recommended under DOT (Directly Observed Therapy)
  • Treatment duration: 24 weeks
  • Strict monitoring required
  • Used only in MDR-TB cases

8. Technical Product Specification Table

Feature Details
Product Name Bedaquiline Tablets 100mg
Active Ingredient Bedaquiline Fumarate
Drug Class Diarylquinoline Antibiotic
Strength 100mg
Usage MDR-TB Treatment
Form Oral Tablet
Packaging Blister Pack / Export Pack
Shelf Life 24–36 Months
Storage Below 25°C
Certification WHO-GMP, ISO

9. Why Global Buyers Choose Taj Medico

We are recognized as a Leading #1 Bedaquiline Tablets 100mg Manufacturer & Supplier in India due to:

  • High-quality production standards
  • Consistent global supply chain
  • Affordable pricing structure
  • Regulatory compliance support
  • Trusted international reputation

We ensure seamless Bedaquiline Tablets 100mg export from India with full documentation support.


10. Top Export Countries (20 Markets)

  1. USA
  2. UK
  3. South Africa
  4. Nigeria
  5. Kenya
  6. UAE
  7. Saudi Arabia
  8. Brazil
  9. Mexico
  10. Peru
  11. Vietnam
  12. Philippines
  13. Indonesia
  14. Egypt
  15. Turkey
  16. Iraq
  17. Bangladesh
  18. Sri Lanka
  19. Russia
  20. Thailand

11. Call to Action

Global distributors, hospital suppliers, and importers looking for a WHO-GMP Bedaquiline Tablets 100mg Manufacturer in India can connect with Taj Medico for bulk orders, export inquiries, and long-term business partnerships.

We ensure reliable supply, competitive pricing, and complete regulatory assistance for international markets.


12. Top 20 FAQs

1. What is Bedaquiline Tablets 100mg used for?
Used for treating multidrug-resistant tuberculosis (MDR-TB).

2. Who manufactures Bedaquiline Tablets in India?
Taj Medico is a leading manufacturer.

3. Is it safe?
Yes, under medical supervision.

4. What is its mechanism?
It inhibits ATP synthase in TB bacteria.

5. What is MDR-TB?
A drug-resistant form of tuberculosis.

6. What is dosage duration?
Typically 24 weeks.

7. Can it be exported?
Yes, globally.

8. Which countries import it?
Africa, Asia, LATAM, Middle East.

9. What certifications are available?
WHO-GMP, COPP, CTD.

10. Storage conditions?
Below 25°C, dry place.

11. Side effects?
Nausea, headache, joint pain.

12. Is it prescription-based?
Yes.

13. Can children use it?
Under strict supervision.

14. Packaging type?
Blister export packs.

15. Shelf life?
24–36 months.

16. Is DOT required?
Yes.

17. Export documentation provided?
Yes.

18. Is it WHO approved?
Manufactured in WHO-GMP facility.

19. What is composition?
Bedaquiline fumarate 100mg.

20. Who is the best exporter?
Taj Medico, India.