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Metabolic API

Roxadustat API

Lewens Labs develops and manufactures Roxadustat API — HIF prolyl-hydroxylase (HIF-PH) inhibitor, a first-in-class oral HIF-PH inhibitor for renal anaemia — used in anaemia associated with chronic kidney disease, at its GMP facility in Gujarat, India.

API
Roxadustat
Therapeutic area
Metabolic
Drug class / mechanism
HIF prolyl-hydroxylase (HIF-PH) inhibitor
Indication
Used in anaemia associated with chronic kidney disease
CAS number
to confirm
Molecular formula
to confirm
Grade / pharmacopoeia
on request
DMF / CEP status
on request
Registrations
on request

Note for Lewens: populate CAS, formula, grade, DMF/CEP & registrations for Roxadustat from the Regulatory master list.

01 The chemistry

Why Roxadustat rewards process depth.

Roxadustat involves isoquinoline chemistry with control of regiochemistry and impurities.

Lewens' integrated platform — process R&D, analytical development and manufacturing under one team — is built for exactly this kind of technically demanding molecule. We can support Roxadustat as commercial supply, as a second source, or as a development and custom-synthesis programme through our CDMO platform.

02 Supply models

Three ways to source Roxadustat.

Commercial

Ongoing supply

Reliable, on-specification commercial quantities of Roxadustat API for your registered product.

Second source

Alternate supplier

De-risk your supply chain for Roxadustat with a dependable additional or backup source.

Development

Custom & CDMO

Process development, improvement or exclusive arrangements for Roxadustat under NDA.

03 Related

More in Metabolic.

Metabolic

Resmetirom

thyroid hormone receptor-beta (THR-β) agonist.

View Resmetirom
04 Questions

Roxadustat API — FAQs.

Does Lewens manufacture Roxadustat API?
Yes. Lewens develops and manufactures Roxadustat API at its GMP facility in Gujarat, India. Samples, specifications and regulatory documentation, including DMF/CEP status, are available on request under confidentiality.
Can Lewens supply Roxadustat as a second source?
Yes. Lewens works with companies seeking a reliable second-source or alternate supplier of Roxadustat API — share grade, volumes and timeline to begin.
What is Roxadustat used for?
Roxadustat is HIF prolyl-hydroxylase (HIF-PH) inhibitor, a first-in-class oral HIF-PH inhibitor for renal anaemia, used in anaemia associated with chronic kidney disease.
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Request specifications, samples or DMF/CEP documentation — or discuss a second-source or custom-synthesis programme.

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