Bedaquiline API Manufacturers and Suppliers in India
Bedaquiline is a BCS Class II drug used to treat MDR-TB (multi- drug resistant tuberculosis) in adults and children ages 5 and over. It is part of the BPal (Bedaquiline Pretomanid Linezolid) treatment regimen that is being rolled out in India that has 89% success rate in six months versus the 52% success rate offered by standard care in 18 months. The WHO recommends a six-month all-oral regimen called BPaLM (bedaquiline, pretomanid, linezolid, and moxifloxacin) for people with MDR/RR-TB or MDR/RR-TB with additional resistance to fluoroquinolones (pre-XDR-TB).
Product Description
Name of the product: Bedaquiline Fumarate
Chemical Name: (1R,2S)-1-(6-Bromo-2-methoxy-3-quinolyl)-4-dimethylamino-2-(1-naphthyl)-1-phenylbutan-2-ol
CAS Number: 845533-86-0
Molecular weight: 671.59 g/mol
Molecular Formula: C36H35BrN2O6
Category: BCS Class II
Therapeutic use: To treat pulmonary multi-drug resistant tuberculosis (MDR-TB)
Form: Crystalline powder
Color: White to off white
Size of package: As per requirement
Synonyms: BDQ fumarate, R403323, TMC-207, and UNII-P04QX2C1A5
Solubility: Freely soluble in methanol and Dimethyl formamide and practically insoluble in water
Bedaquiline Fumarate API Specification
☐ Assay by HPLC: Not less than 98.0% and not more than 102.0% (On a dried basis)
☐ Total Impurities: Not more than 0.3%
☐ Any Unspecified impurity: Not more than 0.1%
Quality Standards and Manufacturing Excellence of Bio-Synth
Our manufacturing processes integrate:
☐ WHO-GMP (Good Manufacturing Practices) compliance
☐ ISO 9000:2015 certification
☐ Adherence to ICH guidelines and pharmacopeia standards
Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence. ESG goals remain integral to our organization and are pursued and tracked strictly.
Chemical properties:
It is a white to off-white crystalline powder with low solubility in water
Applications of Bedaquiline API
☐ To treat active tuberculosis, particularly multi-drug-resistant tuberculosis (MDR-TB) in adults and in children ages 5 and older
☐ Part of the BPal (Bedaquiline, Pretomanid and Linezolid) treatment regime being rolled out in India
☐ WHO recommends a six-month all-oral regimen called BPaLM (bedaquiline, pretomanid, linezolid, and moxifloxacin) for people with MDR/RR-TB or MDR/RR-TB with additional resistance to fluoroquinolones (pre-XDR-TB).
Therapeutic Uses and Indications
Bedaquiline is part of the BPal (Bedaquiline, Pretomanid and Linezolid) shortened regime being rolled out in India- with 89% success rate in six months in comparison to the 52% success rate provided by standard care in 18 months.
WHO recommends Bedaquiline as a component of the 9-month all-oral regimen, which is the treatment of choice for eligible people aged under 14 years with MDR/RR-TB rather than longer (18 month) regimens.
For people aged 14 years and over with MDR/RR-TB, WHO suggests the use of a 6-month treatment regimen composed of bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM) rather than the 9-month or longer (18 month) regimens. In cases of documented resistance to fluoroquinolones, BPaL without moxifloxacin would be initiated or continued
How Bedaquiline API Works (Mechanism of Action)
Bedaquiline fumarate, an antituberculosis drug, works by binding to the adenosine triphosphate (ATP) synthase enzyme in mycobacteria, which prevents the production of ATP.
Why Choose Bio-Synth for Bedaquiline API
Bio-Synth adheres to stringent quality protocols to ensure that each batch of Bedaquiline meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results. We manufacture Bedaquiline Fumarate in our 120kL WHO-GMP, ISO certified facility with a capacity of 3 MT/year. Bio-synth has more than four decades of experience manufacturing complex APIs such as Bedaquiline
Advantages and Key Features of Bedaquiline API
☐ Effective against drug-resistant tuberculosis: Bedaquiline can be effective against some tuberculosis isolates that are resistant to other drugs. It can also improve treatment outcomes for patients with rifampin-resistant tuberculosis.
☐ Shorter treatment duration: Bedaquiline regimens can be shorter than traditional regimens.
☐ Reduced toxicity: Bedaquiline regimens can have reduced toxicity compared to traditional regimens.
☐ Increased cure rates: Bedaquiline regimens can have increased cure rates compared to traditional regimens
Bedaquiline API Suppliers & Manufacturers in India
Bio-synth is one of the first and leading Anti-TB drug manufacturers in India. Bio-synth manufactured PAS Sodium in 1956, one of the integral Anti-TB drugs from 1950s- 2010s. Continuing the legacy of being the leading anti-TB drug manufacturers, Bio-synth was one of the very first to develop Bedaquiline fumarate in 2024 to cater to the international and Indian markets. With proven and established processes and technology, Bio-synth is well-positioned to cater to the Bedaquiline demand globally and in India.
Bedaquiline API Price in India
Bio-Synth offers premium-quality Bedaquiline Fumarate at competitive prices, tailored to meet your specific requirements. Our streamlined in-house manufacturing process ensures consistent quality and cost efficiency, making us a trusted choice for pharmaceutical companies and veterinary medicine manufacturers.
By handling all production stages internally, we maintain strict control over quality while optimizing pricing. This approach allows us to deliver reliable Bedaquiline fumarate solutions that adhere to global standards such as WHO-GMP and ISO certifications. We are also in the process of gaining WHO prequalification.
For accurate pricing and to discuss your specific needs, we encourage you to reach out with your inquiry. Our team is dedicated to providing timely responses and ensuring your complete satisfaction.
Benefits:
Solubility: Bedaquiline has low aqueous solubility.
Permeability:It exhibits high permeability across biological membranes.
Class II drugs are characterized by their poor solubility but good permeability, which can impact their absorption and bioavailability.
Related intermediates:
Frequently asked questions
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If you are looking to source Bedaquiline API, Bio Synth is an excellent choice. Bio Synth is known for its high-quality manufacturing practices and reliable supply of active pharmaceutical ingredients (APIs), including Bedaquiline API.
The price of Bedaquiline API provided by Bio-Synth depends on several factors, including order quantity, quality standards, and current market conditions. To get an accurate and customised quote, it’s best to contact Bio-Synth us directly, as we ensure competitive pricing and adherence to regulatory standards.
Bedaquiline is a medication used to treat active tuberculosis. Specifically, it is used to treat multidrug-resistant tuberculosis along with other medications for tuberculosis.
Bedaquiline fumarate is an anti-tuberculosis drug that selectively inhibits the mycobacterial energy metabolism i.e. ATP synthesis and is found to be effective against all states of Mycobacterium tuberculosis.
Bedaquiline is classified as a class II drug and is primarily used as an anti-TB (tuberculosis) drug. It is specifically used in the treatment of multi-drug resistant tuberculosis (MDR-TB). Class II drugs are characterized by having a high permeability and low solubility, which affects their absorption in the body.
Bio-Synth adheres to strict regulatory standards to ensure the quality and reliability of its Bedaquiline API. The company is WHO-GMP (World Health Organization Good Manufacturing) certified and ISO 9000:2015 certified, demonstrating its commitment to maintaining the highest quality management systems. Additionally, Bio-Synth is actively working to obtain EU-CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) and US-FDA (United States Food and Drug Administration) certifications, establishing its commitment to conquer the world all regulatory requirements fulfill the emphasis and expanding reach to international markets.
Bedaquiline is used in combination with at least three other agents to treat pulmonary multidrug-resistant tuberculosis (MDR-TB). It’s available as an oral tablet and is licensed for a 24-week course of treatment
Bio-Synth has been the market leader in anti-TB drugs for over 8 decades. Continuing the legacy, Bio-Synth is one of the first and leading manufacturers of Bedaquiline, with superior product quality, competitive price and short lead time.
Yes, we manufacture and supply intermediates of Bedaquiline
Bio-synth passes on the cost advantage of established technology and in-house manufacturing of all stages to its customers, thereby guaranteeing the most competitive prices in the market. Please reach out via the enquiry form with your requirements to avail the best quote
Bedaquiline is used to treat MDR- TB (multi- drug resistant tuberculosis) in adults and children ages 5 and older
Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate:
☐ WHO-GMP (Good Manufacturing Practices) compliance
☐ ISO 9000:2015 certification
☐ Adherence to ICH guidelines and pharmacopeia standards
Bio-Synth offers Bedaquiline that meets global and local standards and specifications at a competitive price.
Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.
Please reach out via the contact form with your requirements to place an order for Bedaquiline API.
