Bedaquiline API Manufacturers and Suppliers in India

Bedaquiline API Manufacturers & Suppliers
Bedaquiline is a diarylquinoline antitubercular drug and the backbone of today’s all-oral regimens for multidrug-resistant and rifampicin-resistant tuberculosis (MDR/RR-TB). Bio-Synth manufactures it as bedaquiline fumarate, the salt used in oral tablets, at its plant in Balanagar, Hyderabad. The API is a white to off-white crystalline powder. It is practically insoluble in water and freely soluble in methanol and dimethylformamide, which puts it in BCS Class II: dissolution, not permeability, is what limits absorption.

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Product Description

Chemical Name: (1R,2S)-1-(6-Bromo-2-methoxy-3-quinolyl)-4-dimethylamino-2-(1-naphthyl)-1-phenylbutan-2-ol, fumarate (1:1)

CAS Number: 845533-86-0

Molecular Formula: C36H35BrN2O6

Molecular Weight: 671.59 g/mol

Therapeutic category: Antitubercular (diarylquinoline)

BCS class: Class II

Form and colour: White to off-white crystalline powder

Solubility: Freely soluble in methanol and dimethylformamide; practically insoluble in water

Packing: As per requirement

Synonyms: BDQ fumarate, TMC-207, R403323, UNII-P04QX2C1A5

Check the salt before you compare quotes. Some suppliers list the free base instead (CAS 843663-66-1, C32H31BrN2O2, 555.52 g/mol). One kilogram of the fumarate carries about 827 g of bedaquiline base, so a per-kg price for one is not a per-kg price for the other.

Bedaquiline API Specification

Every batch is released against a written specification and dispatched with its own Certificate of Analysis. Key specification limits:


Test Limit
Assay by HPLC (on dried basis) 98.0% to 102.0%
Total impurities Not more than 1.0%
Any unspecified impurity Not more than 0.1%
Residue on ignition Not more than 0.1%

Ask about chiral purity specifically. Bedaquiline has two stereocentres, and the step that joins the two main intermediates creates both of them at once, so the unwanted stereoisomers have to be separated out afterwards. Published process chemistry on bedaquiline focuses on exactly this step. A limit for the other stereoisomers belongs next to the assay on any bedaquiline CoA you accept.

Bedaquiline Manufacturers in India

Biochemical and Synthetic Products Private Limited (Bio-Synth) was founded in Hyderabad in 1943. Bedaquiline is made at its Balanagar site, which Bio-Synth operates under drug manufacturing licence 118/HD/AP/96/B/R.


TB drugs are not new to this plant. Bio-Synth’s WHO-GMP certificate was issued for two grades of aminosalicylate sodium (PAS sodium), an older drug still used against drug-resistant TB. A separate article on the role of bedaquiline and aminosalicylate sodium in TB treatment sets the two side by side.


The route runs through two intermediates that Bio-Synth also sells as products. 3-Benzyl-6-bromo-2-methoxyquinoline supplies the quinoline half of the molecule. 3-(Dimethylamino)-1-(naphthalen-1-yl)propan-1-one hydrochloride supplies the naphthyl carbinol and the dimethylaminoethyl chain. Because both are made here, the impurities that reach the final coupling come from processes controlled on site, not from an outside vendor whose route can change without notice.


For a buyer this shows up in three places: impurity profiles that hold steady from lot to lot, change control that covers the whole route, and lead times that do not depend on a third-party intermediate arriving on time.

Bedaquiline Intermediate Manufacturers and Suppliers in India

Bio-Synth sells both key bedaquiline intermediates to companies running their own route or qualifying a second source.

3-Benzyl-6-bromo-2-methoxyquinoline

CAS 654655-69-3. C17H14BrNO, 328.20 g/mol. White to off-white crystalline powder, soluble in organic solvents such as chloroform. In the published route it is deprotonated at the benzylic carbon and added to the ketone below. Full data are on the 3-Benzyl-6-bromo-2-methoxyquinoline product page.

3-(Dimethylamino)-1-(naphthalen-1-yl)propan-1-one Hydrochloride

CAS 5409-58-5. C15H18ClNO, 263.76 g/mol. White to off-white powder, soluble in methanol. This Mannich-base ketone becomes the carbinol carbon of bedaquiline and carries the dimethylaminoethyl side chain into the molecule. See the 3-(Dimethylamino)-1-(naphthalen-1-yl)propan-1-one hydrochloride product page.

Bedaquiline Suppliers in India

If your bedaquiline tablets are headed for a national TB programme or a donor-funded tender, the paperwork matters as much as the powder. A first order usually runs like this:


  1. You send the specification you need, the quantity and the destination market.
  2. Bio-Synth shares its specification and a recent CoA for your review. Samples can be supplied as well.
  3. Bio-Synth quotes with lead time and packing.
  4. Each dispatch carries its batch CoA and other pertinent documents such as SDS, TSE/BSE and residual solvent statements..

If the tablets are headed for a WHO prequalification dossier, Bio-synth can support with the required documentation as well.

Bedaquiline API Price in India

Bio-Synth quotes bedaquiline fumarate per order; there is no list price. These are the things that move the number:


  • Salt basis. A fumarate quote and a free-base quote differ by about 17% in active content before anything else is considered.
  • Specification. Tighter limits on stereoisomers and unspecified impurities take more purification to meet.
  • Volume and schedule. Campaign size and a firm delivery plan both affect the per-kg rate.
  • Documentation. A lot that has to support a WHO PQ or regulated-market filing carries more testing and paperwork than one for a domestic registration.

As a market reference, bulk bedaquiline API trades at an average of around ₹2.2 lakh (about $2,600) per kg, with individual lots priced above or below that depending on salt form, grade, volume and documentation. Compare quotes only once those match.

Quality and Compliance

  • ISO 9001:2015. Bio-Synth’s quality management system is certified by DNV Business Assurance (UKAS accredited) under certificate 156792-2014-AQ-IND-UKAS, first issued on 20 August 2002. The certified scope reads: “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”.
  • WHO-GMP. The site holds WHO-GMP certificate L.Dis.No. 150458/TS/2024, issued by the Drugs Control Administration, Government of Telangana, and valid until 5 June 2027 for select products
  • ICH Q7. Bedaquiline fumarate is manufactured in line with ICH Q7 principles for active pharmaceutical ingredients.
  • Batch release. Each lot is released by QC with its CoA. The company’s quality control and GMP systems are described in more detail on the quality page.

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

How Bedaquiline Works and Where It Is Used

Bedaquiline blocks ATP synthase in Mycobacterium tuberculosis, shutting down the energy supply of both dividing and dormant bacilli. It was the first TB drug to work through this target. A dedicated post on bedaquiline mechanism of action covers the binding site in more detail.


WHO guidance puts bedaquiline at the centre of shorter, all-oral treatment for drug-resistant TB. For people aged 14 and over with MDR/RR-TB, WHO suggests the six-month BPaLM regimen (bedaquiline, pretomanid, linezolid and moxifloxacin), with moxifloxacin dropped where fluoroquinolone resistance is documented. For eligible children under 14, a nine-month all-oral regimen containing bedaquiline is the preferred option. Clinical use is covered further in the article on bedaquiline uses in MDR-TB treatment.

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Bedaquiline API FAQs

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Please write in your queries and we will get back to you.


    Bedaquiline treats pulmonary multidrug-resistant and rifampicin-resistant tuberculosis. It is always given with other TB drugs, and the shorter all-oral regimens that WHO recommends for drug-resistant TB are built around it.
    The originator brand is Sirturo, from Janssen (Johnson & Johnson). Generic bedaquiline tablets are now made by several companies, including Indian manufacturers.
    Yes. In March 2023 the Indian Patent Office rejected Johnson & Johnson’s secondary patent application on bedaquiline. That cleared the way for Indian API and tablet makers once the main patent expired in July 2023.
    Bio-Synth supplies bedaquiline fumarate (CAS 845533-86-0, 671.59 g/mol), the salt used in tablets. The free base has a different CAS number (843663-66-1) and molecular weight (555.52 g/mol), so check which one a quote refers to.
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    Bio-Synth supplies 3-benzyl-6-bromo-2-methoxyquinoline (CAS 654655-69-3) and 3-(dimethylamino)-1-(naphthalen-1-yl)propan-1-one hydrochloride (CAS 5409-58-5), each as a separate product.

    Every batch is dispatched with its Certificate of Analysis. Share your destination market when you enquire so the full document set your filing needs can be agreed.

    Bedaquiline fumarate is manufactured in line with ICH Q7 principles at Bio-Synth’s licensed Balanagar site. The site’s WHO-GMP certificate covers the products named in its annexure, so ask Bio-Synth for the current schedule before citing it in your own dossier.

    Request a Quotation

    Send Bio-Synth the salt form, the specification or pharmacopoeial reference you work to, the quantity, your delivery schedule and destination market, and whether you need either intermediate as well. Share those through the contact page and the team will come back with a specification, a recent CoA and a quotation.

    Bio-Synth also makes aminosalicylate sodium and a range of other generic APIs. See the full API portfolio