Bilastine API Manufacturers and Suppliers in India

Bilastine API Manufacturers & Suppliers

Bilastine is a second-generation H1 antihistamine, CAS 202189-78-4, molecular formula C28H37N3O3, molecular weight 463.62 g/mol. It is supplied as a white to yellowish powder for use in oral tablet and oral solution formulations for allergic rhinoconjunctivitis and chronic urticaria. Bio-Synth manufactures Bilastine API and both of its key intermediates at its Balanagar plant in Hyderabad.

Check Price

Product Description

Name of the product: Bilastine

Chemical Name : 2-[4-(2-{4-[1-(2-Ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl}ethyl)phenyl]-2-methylpropanoic acid

CAS Number: 202189-78-4

Molecular weight: 463.62 g/mol

Molecular formula: C28H37N3O3

Category: Second-generation H1 antihistamine

BCS classification:  Class II

Form: Powder

Color: White or yellowish

Solubility: Sparingly soluble in 0.1N sodium hydroxide; insoluble in water

Storage: Preserve in a well-closed container

Packing: As per requirement

Synonyms: F-96221-BM1

Bilastine is not a salt or a hydrate. If a supplier quotes you Bilastine Monohydrate, that is a different material – check which form your dossier specifies before you compare prices.

Bilastine API Specification:

Every batch ships against a specification and a Certificate of Analysis. The tests that appear on it:
  • ☐ Description and solubility
  • ☐ Identification by IR and by HPLC retention time
  • ☐ Assay by HPLC
  • ☐ Related substances – individual and total impurity limits, controlled against ICH Q3A
  • ☐ Residual solvents by GC, against ICH Q3C class limits
  • ☐ Loss on drying and sulphated ash / residue on ignition
  • ☐ Heavy metals or elemental impurities
  • ☐ Particle size distribution, where it forms part of the agreed specification
Bilastine is a BCS Class II molecule – low solubility, high permeability – so dissolution behaviour is driven by particle size and surface area. Agree the D50 and D90 you need at the enquiry stage rather than after the first drum arrives, and state whether your formulation requires a micronised grade. Bio-Synth offers IP and IHS  grades with an assay range of 98%-102% w/w basis, total impurities of not more than 1.0% and LOD not more than 1.0% with a monthly capacity of 2MT. 

Bilastine API Manufacturers in India

Bio-Synth – Biochemical and Synthetic Products Private Limited – has manufactured active pharmaceutical ingredients at Balanagar, Hyderabad since 1943, under manufacturing licence 118/HD/AP/96/B/R. What matters for Bilastine specifically is that the route runs end to end on site. Both key intermediates are made in-house, so the benzimidazole coupling and the final alkylation are under one quality system rather than split across vendors. That has three practical consequences for a buyer:
  • ☐ Impurity control starts upstream. Most Bilastine impurity risk is carried in from intermediate quality. Owning both steps means the process impurity profile is controlled from the beginning of the route, not corrected at the end.
  • ☐ Change control is single-source. A change to intermediate synthesis does not have to be negotiated with an outside supplier before your dossier can be updated.
  • ☐ Lead time is not gated by a third party. Campaign scheduling depends on Bio-Synth’s own plant, not on an intermediate supplier’s queue.
The plant runs multi-step synthesis across glass-lined and stainless reactor trains with in-house QC. Manufacturing follows ICH Q7 principles for active pharmaceutical ingredients – process validation, change control, validated cleaning between campaigns and complete batch records. Details of the reaction capabilities available on site are published separately.

Bilastine Intermediates Manufacturers and Suppliers in India

Bio-Synth supplies both key Bilastine intermediates as standalone products, to formulators and to other API manufacturers.

Methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropanoate

The chloroethyl building block that carries the propanoate side chain into the molecule. Product data and specification are on the Methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropanoate page.


Methyl 2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoate

The advanced intermediate – the coupled benzimidazole-piperidine ester, one hydrolysis step from Bilastine.

Buying the intermediate rather than the finished API makes sense if you run the last step yourself, or if you are qualifying a second source for a step you already own. Both are quoted on the same terms as the API: specification, CoA, sample quantity first, then commercial volume.

Bilastine API Applications

☐ Bilastine fumarate, an antituberculosis drug, works by binding to the adenosine triphosphate (ATP) synthase enzyme in mycobacteria, which prevents the production of ATP.

☐ India is rolling out a BPal shortened treatment regime. BPal, the new treatment regime involves the use of three medicines, Bedaquiline, Pretomanid and Linezolid with an 89 percent success rate within six months. The standard care, on the other hand, takes 18 months with a 52 percent success rate.

☐ Bilastine fumarate is classified under the Biopharmaceutical Classification System (BCS) as a Class II compound. This classification is based on its properties

Bilastine API Suppliers in India

Pack size is agreed per order. For a solid API of this class the standard configuration is HDPE drums with double liners, tamper-evident sealing and labelling that carries product name, batch number, manufacturing and retest dates and net quantity. Our note on packaging size for Bilastine API explains why drum size is worth deciding before the first order rather than after it.

The document set that travels with a consignment: Certificate of Analysis, safety data sheet, and – depending on the destination – a Certificate of Pharmaceutical Product. Export requirements by market are covered in the Bilastine API export rules guide.

A first order normally runs: specification and representative CoA, then a sample for your own identity, assay and impurity checks, then a quotation with Incoterms, lead time and minimum order quantity in writing, then vendor qualification.

Bilastine API Price in India

Bilastine is quoted per kilogram against a specific specification and volume. Four things move the number:
  • ☐ Grade and specification. A micronised or tightened-impurity grade costs more to make than a standard one.
  • ☐ Order volume. Campaign economics dominate – a full campaign quantity prices very differently from a trial kilogram.
  • ☐ Packing configuration. Small packs cost more per kilogram than bulk drums.
  • ☐ Lead time. Slotting into a scheduled campaign is cheaper than displacing one.
Published marketplace listings for Bilastine API in India sit in a wide band, which is why like-for-like comparison matters more than a headline figure. Check the form, the grade and the specification before you put two quotes side by side. Send your specification, quantity and destination and you will get a quotation rather than a range.

Quality and Compliance

The Balanagar site holds ISO 9001:2015 certification issued by DNV under UKAS accreditation, certificate number 156792-2014-AQ-IND-UKAS, initially certified in August 2002. The certified scope reads “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”. Manufacturing follows ICH Q7 principles, with ICH Q3A and Q3C governing impurity and residual solvent limits and ALCOA+ applied to laboratory and batch records. More is on the quality management system page.

The site also holds a WHO-GMP certificate issued by the Drugs Control Administration, Government of Telangana – L.Dis.No. 150458/TS/2024 dated 06/06/2024, valid until 05/06/2027. This is a facility-level certificate issued under the export scheme, and it covers the products named in the joint inspection report attached to it. We would rather say that plainly than imply more: ask us which certificate names which product, and we will send the annexure.

How Bilastine Works and Where It Is Used

Bilastine is a selective H1 receptor antagonist. It blocks histamine from binding at the H1 receptor, which stops the downstream itching, swelling and vasodilation that produce allergy symptoms. Onset is fast – clinical effect begins within about 20 minutes of an oral dose – and it is taken once daily.

The reason formulators reach for it over a first-generation antihistamine is what it does not do. Bilastine crosses the blood-brain barrier poorly, so it is non-sedating at therapeutic dose and carries none of the antimuscarinic effects of the older agents. It is also not extensively metabolised, which keeps its drug-interaction profile narrow.

Indications are allergic rhinoconjunctivitis – sneezing, nasal itch and congestion, watery eyes – and chronic urticaria. Both acute and long-term use are established.

Polymorph selection matters at formulation stage; the difference between the two forms is set out in Bilastine Form I vs Form II.

Bilastine API FAQs

We are listening.

We believe that the heart of dialogue is listening.
Please write in your queries and we will get back to you.


    It is quoted per kilogram against your specification and volume, not sold at a list price. Grade, order quantity, packing and lead time all move the figure. Send the specification and quantity and you will get a firm quotation.

    202189-78-4. Molecular formula C28H37N3O3, molecular weight 463.62 g/mol.

    Yes – both key intermediates are made in-house and are also sold as standalone products. That is why the impurity profile is controlled from the start of the route rather than corrected at the end.

    Certificate of Analysis, safety data sheet, and a Certificate of Pharmaceutical Product where the destination requires one. Specification sheet and a representative CoA are available before you order.

    Yes. Sample quantity first is the normal sequence, so your QC laboratory can run its own identity, assay and impurity checks before a purchase order exists.

    The site holds ISO 9001:2015 (certificate 156792-2014-AQ-IND-UKAS) covering development, manufacture and sale of APIs and intermediates, and a WHO-GMP certificate held at facility level for the products named in its joint inspection report. Ask for the annexure and we will send it – a certificate covers what it names.

    No. Bio-Synth supplies Bilastine, CAS 202189-78-4. Monohydrate is a different material with different specification. Check which your dossier calls for before comparing suppliers.