Bedaquiline Tablets 100mg

Bedaquiline Tablets 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Bedaquiline Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. 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

Introduction to Bedaquiline Tablets 100mg

Bedaquiline Tablets 100mg are a critical breakthrough in the treatment of multi-drug-resistant tuberculosis (MDR-TB) — a severe form of tuberculosis that resists conventional antibiotics like rifampin and isoniazid. Developed as a diarylquinoline-class antibiotic, Bedaquiline works by inhibiting the ATP synthase enzyme of Mycobacterium tuberculosis, thereby halting bacterial energy production and ensuring bacterial death.

Bedaquiline represents a milestone in global TB control programs and is endorsed by the World Health Organization (WHO) for use in MDR-TB treatment regimens. Due to the growing incidence of resistant tuberculosis strains worldwide, the demand for Bedaquiline Tablets 100mg has surged across Asia, Africa, Latin America, and Eastern Europe.

Taj Pharma, a leading Bedaquiline Tablets 100mg manufacturer in India, ensures affordable access and consistent quality for global buyers, government institutions, and NGOs engaged in TB eradication programs.

Global Demand, Use & Benefits

Therapeutic Use:

• Indication: Used in combination with other TB medicines to treat pulmonary tuberculosis caused by Mycobacterium tuberculosis resistant to rifampin, isoniazid, or other common anti-TB agents.

• Mechanism: Bedaquiline inhibits mycobacterial ATP synthase, crucial for bacterial survival.

• Dosage: Usually administered as 100mg tablets under strict medical supervision and WHO TB program protocols.

Benefits of Bedaquiline Tablets 100mg:

• Effective against MDR-TB strains where conventional antibiotics fail.

• Shortens treatment duration and improves cure rates.

• Ensures higher patient adherence due to its oral dosage form.

• Recognized by global health authorities including WHO, USFDA, and EMA.

In-depth Details for Importers, Exporters & Global Buyers

Taj Pharma ensures global buyers, distributors, and procurement agencies receive fully compliant export documentation, custom packaging, and technical support for registration in their local markets.

Regulatory & Export Documentation Provided:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP / EU-GMP Certificate

• Drug Master File (DMF) / CTD Dossier

• Certificate of Analysis (CoA)

• Certificate of Origin (CoO)

• Free Sale Certificate

• Batch Manufacturing Record

• Stability Data (as per ICH guidelines)

Packaging & Labeling:

• Available in 10 x 10 tablets per blister pack or as per buyer’s custom requirement.

• Multilingual labeling options for export markets.

• Anti-counterfeit hologram and tamper-proof sealing for safety.

Shelf-life & Storage:

• Shelf Life: 24 to 36 months from manufacturing date.

• Storage: Store below 30°C in a cool, dry place, away from direct sunlight and moisture.

Dosage Form:

• Bedaquiline Tablets 100mg, film-coated, for oral administration.

Export Certifications:

Taj Pharma holds prestigious international certifications ensuring global regulatory acceptance:

• WHO-GMP (World Health Organization Good Manufacturing Practice)

• EU-GMP (European Union GMP)

• ISO 9001:2015 Quality Certification

• COPP (Certificate of Pharmaceutical Product)

• CTD / ACTD Dossier support

Target Export Markets:

Taj Pharma successfully exports Bedaquiline Tablets 100mg to:
Nigeria, Kenya, South Africa, Vietnam, Philippines, Myanmar, Sri Lanka, Bangladesh, Cambodia, Afghanistan, Nepal, Iraq, Yemen, Ghana, Sudan, Ethiopia, Peru, Dominican Republic, Chile, and Ecuador.

Why is the Most Trusted Manufacturer, Supplier, and Exporter of Bedaquiline Tablets 100mg

State-of-the-Art Manufacturing:

Taj Pharma’s manufacturing plant in Vapi, Gujarat, is one of India’s most advanced pharmaceutical production facilities, fully compliant with WHO-GMP and EU-GMP standards. The facility features:

• Automated production lines

• Dedicated sterile zones

• In-house R&D and analytical labs

• Microbiological quality control laboratories

Affordable Pricing & Quality Assurance:

Taj Pharma’s mission is to make life-saving anti-TB medicines affordable and accessible globally. By integrating backward manufacturing and efficient supply chain management, the company ensures competitive pricing without compromising quality.

Each batch of Bedaquiline Tablets 100mg undergoes rigorous testing for:

• Purity

• Potency

• Dissolution

• Uniformity

• Stability

Global Presence & Supply Chain Support:

Taj Pharma has established export networks across 100+ countries, providing seamless logistics, timely shipments, and full regulatory support for product registration.

Top 20 Countries Taj Pharma Exports Bedaquiline Tablets 100mg To:

India | UAE | Saudi Arabia | Oman | Kenya | Nigeria | South Africa | Ghana | Vietnam | Myanmar | Philippines | UK | Germany | France | Brazil | Chile | Peru | Colombia | Mexico | USA

Customer-Centric Approach:

Taj Pharma offers comprehensive PCD Pharma Franchise and Third-Party Manufacturing services across India, ensuring product availability at every regional level.

Technical Product Specification Table

Common Side Effects of Bedaquiline Tablets 100mg

As per clinical data, Bedaquiline Tablets 100mg may cause mild to moderate side effects, which are generally manageable under medical supervision.
Common side effects include:

• Nausea

• Headache

• Joint pain

• Coughing up blood

• Abdominal pain

• Chest pain

• Elevated liver enzymes

Taj Pharma ensures that pharmacovigilance and post-marketing surveillance are strictly maintained to guarantee patient safety and product reliability.

Bedaquiline Tablets 100mg PCD Pharma Franchise Opportunity

Taj Pharma offers exclusive monopoly rights under its PCD Pharma Franchise model for Bedaquiline Tablets 100mg across PAN India. Franchise partners benefit from:

• Attractive profit margins

• Promotional support

• Assured product availability

• Transparent business practices

If you’re looking for Bedaquiline Tablets 100mg manufacturer in Mumbai, Maharashtra, or across Vapi, Gujarat, Taj Pharma is your most reliable partner for contract manufacturing, franchise supply, and bulk export orders.

Why Choose us for Bedaquiline Tablets 100mg

• WHO-GMP & EU-GMP Certified Manufacturer

• End-to-End Export Documentation Support

• In-house R&D and Quality Control Units

• Competitive Global Pricing

• Regulatory Filing Assistance (CTD, eCTD)

• Strong Distribution Network PAN India

• Dedicated Customer Support for Global Buyers

Taj Pharma stands as the 1 Bedaquiline Tablets 100mg manufacturer and exporter in India, recognized for reliability, compliance, and innovation.

Call to Action for Global Buyers, Distributors, and Importers

For bulk export inquiries, third-party manufacturing, or PCD Pharma Franchise partnerships for Bedaquiline Tablets 100mg, contact Taj Pharma India Ltd. today.

📞 Contact Taj Pharma India Ltd.
📍 Address:Vapi, Gujarat, India
🌐 Website: www.tajpharma.com
✉️ Email: info@tajpharma.com |
📞 Phone: +91 84484 44095 (Gen. Enq. 01)

10. Top 20 FAQs 

1. What is Bedaquiline Tablets 100mg used for?
Bedaquiline is used for treating multi-drug-resistant tuberculosis (MDR-TB) when standard antibiotics fail.

2. Who manufactures Bedaquiline Tablets 100mg in India?
Taj Pharma Ltd., Vapi, Gujarat, is one of India’s leading WHO-GMP certified manufacturers.

3. Is Bedaquiline approved by WHO?
Yes, Bedaquiline is WHO-prequalified and approved for use under MDR-TB treatment programs.

4. What is the dosage of Bedaquiline Tablets 100mg?
Typically administered as per a 24-week treatment protocol under medical supervision.

5. How does Bedaquiline work?
It inhibits bacterial ATP synthase, leading to the death of Mycobacterium tuberculosis.

6. Can Taj Pharma export Bedaquiline Tablets worldwide?
Yes, Taj Pharma exports to over 100 countries across Asia, Africa, and Latin America.

7. What certifications does Taj Pharma have?
Taj Pharma holds WHO-GMP, EU-GMP, ISO 9001:2015, COPP, and CTD Dossier support.

8. What are the common side effects?
Nausea, joint pain, headache, increased liver enzymes, and abdominal discomfort.

9. What is the shelf life?
Typically 24–36 months when stored correctly.

10. Is customized packaging available?
Yes, Taj Pharma provides custom export packaging and labeling.

11. Can Bedaquiline be used alone?
No, it must be used in combination with other anti-TB drugs.

12. What is the mechanism of resistance prevention?
Bedaquiline acts on a unique target not shared by other TB drugs, reducing cross-resistance.

13. Is Bedaquiline safe for children?
Use under pediatric guidelines only after physician recommendation.

14. What countries import from Taj Pharma?
Nigeria, Kenya, Vietnam, Sri Lanka, Peru, and more.

15. How to buy Bedaquiline Tablets 100mg in bulk?
Contact Taj Pharma’s export division via email or website inquiry.

16. What is the price range?
Competitive and affordable, based on order volume and destination market.

17. What is the packaging type?
10×10 tablets per box, with export-grade blister packs.

18. Does Taj Pharma support registration assistance?
Yes, full CTD/eCTD dossiers and regulatory documents are provided.

19. Are sample shipments available?
Yes, for government tenders and regulatory registration.

20. Why choose Taj Pharma?
For trusted quality, certified manufacturing, and global credibility in anti-TB medicine supply.

Taj Pharma India Ltd. stands as the leading manufacturer, supplier, and exporter of Bedaquiline Tablets 100mg in India, delivering excellence through WHO-GMP certified production, global compliance, and affordable pricing. Trusted by international procurement agencies and healthcare organizations, Taj Pharma remains the preferred partner for MDR-TB medicine supply worldwide.