Posaconazole API Manufacturers and Suppliers in India
Posaconazole is a broad-spectrum triazole antifungal, CAS 171228-49-2, molecular formula C37H42F2N8O4, molecular weight 700.8 g/mol. It is used in delayed-release tablet, oral suspension and injectable formulations against invasive Aspergillus and Candida infections, mostly in severely immunocompromised patients. It is supplied as a white to off-white solid. Bio-Synth manufactures Posaconazole API with its intermediates in-house at its Balanagar plant in Hyderabad.
Product Description
Product Description
Product name: Posaconazole API
CAS number: 171228-49-2
Molecular formula: C37H42F2N8O4
Molecular weight: 700.8 g/mol
Chemical name: 4-[4-[4-[4-[[(3R,5R)-5-(2,4-Difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one
Category: Azole (triazole) antifungal
Therapeutic use: Prophylaxis and treatment of invasive Candida and Aspergillus infections
Form: Solid
Colour: White to off-white
Solubility: Freely soluble in dichloromethane; soluble in THF; sparingly soluble in methanol
Packing: As per requirement
At 700.8 g/mol with four stereocentres, posaconazole is one of the more demanding azoles to make well. Stereochemical control in the tetrahydrofuran stage decides the impurity profile, so ask any supplier – including this one – how the (3R,5R) centres are controlled and monitored.
Posaconazole API Specification
The published specification for Bio-Synth’s Posaconazole API:
☐ Assay by HPLC: Not less than 98% and not more than 102% w/w
☐ Total impurities: not more than 1.0%
☐ Any single unspecified impurity: not more than 0.1%
☐ Residue on ignition: not more than 0.1 (%w/w)
Each batch ships with a Certificate of Analysis covering description, identification by IR and HPLC, assay, related substances, residual solvents by GC against ICH Q3C class limits, loss on drying and residue on ignition. Posaconazole is polymorphic and practically insoluble in water, so the crystalline form and particle size distribution belong in the agreed specification, not in a later conversation – state the form your dossier references and the PSD your formulation needs at enquiry stage.
Posaconazole API Manufacturers in Ind
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.
Posaconazole is built from distinct structural fragments – the difluorophenyl-tetrahydrofuran core, the piperazine-phenyl chain and the triazolone side arm. Bio-Synth manufactures the intermediates in-house, so the stereochemistry set early in the route and the impurities each fragment carries forward are controlled under one quality system rather than several vendors’ systems. Change control, campaign scheduling and impurity investigation all run inside one plant. The reaction capabilities behind multi-step work of this kind are published separately. Manufacturing follows ICH Q7 principles – process validation, change control, validated cleaning between campaigns, complete batch records. Posaconazole is manufactured at the 60kL Kamareddy facility with a capacity of 0.3MT/month.
Posaconazole API Suppliers in India
Pack size is agreed per order. Standard configuration for a solid API of this class is HDPE drums with double liners, tamper-evident sealing, and labelling with 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. Import documentation and destination-market requirements are covered in our buyer guide to importing Posaconazole API.
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.
Posaconazole API Price in India
Posaconazole is quoted per kilogram against a specific specification and volume. A 37-carbon molecule with four stereocentres carries a longer route and more purification than most APIs, so route efficiency dominates the cost base. Grade and specification, order volume, packing configuration and lead time set the final number; in-house intermediates keep it under one roof.
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 Posaconazole Works and Where It Is Used
Posaconazole blocks sterol 14-alpha-demethylase, the cytochrome P-450 enzyme fungi use to make ergosterol, by binding its heme cofactor. Without ergosterol the fungal cell membrane fails and methylated sterol precursors accumulate, stopping cell growth. The mechanism is unpacked in our note on ergosterol inhibition by Posaconazole API.
Clinically it is used for prophylaxis of invasive Aspergillus and Candida infections in high-risk immunocompromised patients – stem cell transplant recipients with graft-versus-host disease, and haematological malignancy with prolonged neutropenia – and for oropharyngeal candidiasis, including cases refractory to itraconazole or fluconazole. It is highly lipophilic and distributes extensively in tissue, which is why formulation work centres on bioavailability; the formulation side is covered in formulation-ready Posaconazole API.
Posaconazole API FAQs
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Several Indian API makers offer it. Bio-Synth manufactures Posaconazole API with intermediates in-house at Balanagar, Hyderabad, against a published limit of not more than 1.0% total impurities.
171228-49-2. Molecular formula C37H42F2N8O4, molecular weight 700.8 g/mol.
Quoted per kilogram against your specification and volume, not sold at a list price. Route length dominates the cost of this molecule, so like-for-like comparison of specification matters more than a headline figure.
Yes. Posaconazole is polymorphic and practically insoluble in water, so the crystalline form and particle size drive dissolution behaviour. Specify both in the purchase specification.
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.
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 – a certificate covers what it names.
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.
Posaconazole sits in the full API product portfolio.
The chemical composition of Posaconazole API is C37H42F2N8O4 which stands for 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one·
Yes, Posaconazole API is available for purchase in India. Bio-synth is one of the leading manufacturers and suppliers of API products. Please reach out via the enquiry form with your requirement, and we will be happy to assist you.
Bio-Synth has almost 8 decades of experience manufacturing high-quality APIs, with Posaconazole API as one of the key products in its product portfolio, making Bio-Synth one of the trusted manufacturers in India.
Bio-Synth offers high-quality Posaconazole API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures a consistent and reliable Posaconazole API supply, making us a top choice for Posaconazole API suppliers in India.
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 in manufacturing APIs.
To place an order for Posaconazole API, contact Bio-Synth through our customer service team or by filling out the contact form on our website. We provide comprehensive support to guide you through the order process and ensure timely delivery to meet your specific needs.