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What is Bedaquiline?
Bedaquiline is an antibiotic medication used to treat multi-drug resistant tuberculosis (MDR-TB). It belongs to the diarylquinoline class of antibiotics and works by inhibiting the mycobacterial ATP synthase enzyme, which is essential for the bacteria's energy production.
What strength is Bedaquiline available in?
Bedaquiline is available in 100mg tablet form. Our manufacturing facility produces high-quality Bedaquiline tablets 100mg with consistent dosage and bioavailability.
What is MDR-TB?
Multi-drug resistant tuberculosis (MDR-TB) is a form of tuberculosis that is resistant to at least isoniazid and rifampicin, the two most powerful first-line anti-TB drugs. MDR-TB requires treatment with alternative drug regimens that include medications like Bedaquiline.
Are your facilities WHO-GMP certified?
Yes, our manufacturing facilities are WHO-GMP certified. We maintain the highest international quality standards and comply with WHO Good Manufacturing Practices for pharmaceutical production.
What quality control measures do you have?
We implement comprehensive quality control measures including raw material testing, in-process quality checks, finished product analysis, stability testing, and complete documentation traceability. Our facilities are ISO 9001:2015 certified.
Do you have international certifications?
Yes, we hold multiple international certifications including WHO-GMP, ISO 9001:2015, PIC/S compliance, and export licenses for various international markets.
What is the minimum order quantity?
We offer flexible minimum order quantities (MOQ) starting from 1,000 tablets for institutional buyers. For larger orders and government tenders, we can accommodate bulk supply requirements.
Do you provide export documentation?
Yes, we provide complete export documentation including certificates of analysis, manufacturing licenses, WHO prequalification certificates, and all necessary regulatory documentation for international shipments.
Which countries do you export to?
We export to countries across Africa, Southeast Asia, South America, and Eastern Europe. Our global distribution network ensures reliable supply to healthcare systems worldwide.
What is your production capacity?
Our state-of-the-art manufacturing facilities have the capacity to produce millions of Bedaquiline tablets annually, ensuring consistent supply for both domestic and international markets.
How should Bedaquiline be stored?
Bedaquiline tablets should be stored at room temperature (20-25°C), protected from light and moisture. Specific storage conditions should be followed according to the product labeling and local regulatory requirements.
What is the shelf life of Bedaquiline tablets?
The shelf life of our Bedaquiline tablets is typically 24-36 months from the date of manufacture, subject to proper storage conditions. Each batch undergoes stability testing to determine the exact expiration date.
Is Bedaquiline approved by regulatory authorities?
Bedaquiline has been approved by major regulatory authorities including the US FDA, European Medicines Agency, and is included in the WHO Essential Medicines List for MDR-TB treatment.
What are the common side effects?
Common side effects may include nausea, headache, joint pain, and increased liver enzymes. Healthcare professionals should consult the prescribing information for complete details on contraindications and adverse reactions.
Do you offer partnership opportunities?
Yes, we welcome partnership opportunities with pharmaceutical distributors, government agencies, and healthcare organizations. Contact our business development team to discuss potential collaborations.
How can I place an order?
To place an order, please contact our sales team through the contact form or call us directly at +91 84484 44095. Our team will assist you with the ordering process and provide necessary documentation.
Need More Information?
Can't find the answer you're looking for? Our team is here to help with any additional questions about our Bedaquiline tablets, manufacturing processes, or supply arrangements.
Ready to Partner With Us?
Join leading healthcare organizations and governments in combating MDR-TB with high-quality Bedaquiline tablets from a trusted WHO-GMP certified manufacturer.