Vonoprazan API Manufacturers and Suppliers in India
Vonoprazan is a potassium-competitive acid blocker (P-CAB), molecular formula C17H16FN3O2S, molecular weight 345.39 g/mol. It suppresses gastric acid by binding the H+/K+-ATPase proton pump reversibly and potassium-competitively, which gives it a faster onset and longer acid control than conventional proton pump inhibitors. It is supplied as a white to nearly white crystalline powder for oral solid dose formulations. Bio-Synth manufactures Vonoprazan API and both of its key intermediates at its Balanagar plant in Hyderabad.
Name of the product: Vonoprazan API
Chemical Name : 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine
Molecular formula: C17H16FN3O2S
Molecular weight: 345.39 g/mol
Category: Potassium-competitive acid blocker (P-CAB)
Therapeutic use: Acid-related gastrointestinal disorders – GERD, peptic ulcer, H. pylori eradication regimens
Form: Crystalline powder
Color: White to nearly white
Melting point: 194.8 deg C
Solubility: SSoluble in dimethyl sulfoxide; limited solubility in DMA, DMF, methanol and water
Packing: As per requirement
Synonym: TAK-438
One thing to settle before you compare quotes: most finished formulations use vonoprazan as the fumarate salt (CAS 881681-01-2), and the free base carries its own CAS (881681-00-1). The two are different materials with different specifications.
Vonoprazan API Specification
Every batch ships against a specification and a Certificate of Analysis: description, identification by IR and HPLC, assay, related substances with individual and total limits controlled against ICH Q3A, residual solvents by GC against ICH Q3C class limits, loss on drying, residue on ignition, and particle size where it forms part of the agreed specification. Bio-Synth offers Vonoprazan fumarate IP with an assay range of 98%-102% w/w basis, total impurities of not more than 0.5% and LOD not more than 0.5% with a capacity of 0.75MT/month.
Vonoprazan 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.
For Vonoprazan the route runs end to end on site: both key intermediates are synthesised in-house, so the sulfonylation and the final reductive amination sit under one quality system. Impurity control starts at the beginning of the route instead of being corrected at the end, a change to intermediate synthesis needs no negotiation with an outside vendor, and campaign scheduling is not gated by a third party’s queue. The reaction capabilities available on site are published separately. Manufacturing follows ICH Q7 principles – process validation, change control, validated cleaning between campaigns, complete batch records.
Vonoprazan API Intermediate Manufacturers and Suppliers in India
Bio-Synth manufactures both key Vonoprazan intermediates and supplies them as standalone products, with published specifications:
Pyridine-3-sulfonyl chloride
The sulfonylating agent that installs the pyridin-3-ylsulfonyl group on the pyrrole nitrogen. Published limits: purity not less than 99.0%, total impurities not more than 1.0%, any unspecified impurity not more than 0.5%.
5-(2-Fluorophenyl)-1H-pyrrole-3-carbaldehyde
The fluorophenyl-pyrrole core of the molecule, one sulfonylation and one reductive amination from the API. Published limits: purity not less than 95.0%, total impurities not more than 1.0%.
Buying a Vonoprazan API intermediate rather than the finished API makes sense when you run the final steps yourself or are qualifying a second source for a step you already own. Both intermediates are quoted the same way as the API: specification and CoA first, sample quantity next, then commercial volume. The wider pharmaceutical intermediates range is listed separately.
Vonoprazan 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. The document set that travels with a consignment: Certificate of Analysis, safety data sheet, and a Certificate of Pharmaceutical Product where the destination requires one.
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.
Vonoprazan API Price in India
Vonoprazan is quoted per kilogram against a specific specification and volume. Four things move the number: the form and grade quoted (free base and fumarate price differently), order volume against campaign economics, packing configuration, and lead time. In-house intermediates keep the cost base under one roof, which is what allows the quotation to hold once given.
Send your specification, quantity and destination market and you will get a firm 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, scoped to “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 sits 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. It is a facility-level certificate issued under the export scheme, covering the products named in its joint inspection report. Ask which certificate names which product and we will send the annexure.
How Vonoprazan Works and Where It Is Used
Vonoprazan binds the gastric proton pump reversibly and in competition with potassium, rather than requiring acid activation the way a PPI does. That gives it a rapid onset, acid suppression that holds through the night, and activity independent of CYP2C19 metaboliser status. It is also stable in acid, so it needs no enteric protection in formulation.
Clinical use covers gastroesophageal reflux disease and erosive esophagitis, gastric and duodenal ulcer, and Helicobacter pylori eradication in combination with amoxicillin and/or clarithromycin. The clinical background is covered in our note on Vonoprazan API uses.
Vonoprazan API FAQs
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Several Indian API makers offer it, most quoting the fumarate salt. Bio-Synth manufactures Vonoprazan and both of its key intermediates in-house at Balanagar, Hyderabad, which is what differentiates one supplier from another on impurity control and lead time.
A precursor compound used in the synthesis of the finished API – for Vonoprazan, Pyridine-3-sulfonyl chloride and 5-(2-fluorophenyl)-1H-pyrrole-3-carbaldehyde. Both are available from Bio-Synth as standalone products with published specifications.
No. It acts on the same enzyme but belongs to a newer class, the potassium-competitive acid blockers. The binding is reversible and does not need acid activation, which is why onset is faster and night-time acid control is stronger.
Quoted per kilogram against your specification and volume, not sold at a list price. Form, grade, order quantity, packing and lead time all move the figure.
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.
Whichever your dossier names. They carry different CAS numbers and different specifications, so confirm the form before comparing quotations.
Request a Quotation
Send your specification, required quantity, pack size and destination market. You will get the specification sheet, a representative Certificate of Analysis and a quotation with Incoterms and lead time. Contact Bio-Synth with the details.
Vonoprazan sits in the full API product portfolio.
