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Cardiovascular API

Rosuvastatin API

Lewens Labs develops and manufactures Rosuvastatin API — HMG-CoA reductase inhibitor (statin), one of the most widely prescribed lipid-lowering statins worldwide — used in lowering LDL cholesterol and reducing cardiovascular risk, at its GMP facility in Gujarat, India.

API
Rosuvastatin (Rosuvastatin Calcium)
Therapeutic area
Cardiovascular
Drug class / mechanism
HMG-CoA reductase inhibitor (statin)
Indication
Used in lowering LDL cholesterol and reducing cardiovascular risk
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 Rosuvastatin from the Regulatory master list.

01 The chemistry

Why Rosuvastatin rewards process depth.

Rosuvastatin involves a defined chiral profile with tight control of oxidation and diastereomeric 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 Rosuvastatin 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 Rosuvastatin.

Commercial

Ongoing supply

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

Second source

Alternate supplier

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

Development

Custom & CDMO

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

03 Related

More in Cardiovascular.

Cardiovascular

Ticagrelor

P2Y12 platelet aggregation inhibitor.

View Ticagrelor
04 Questions

Rosuvastatin API — FAQs.

Does Lewens manufacture Rosuvastatin API?
Yes. Lewens develops and manufactures Rosuvastatin 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 Rosuvastatin as a second source?
Yes. Lewens works with companies seeking a reliable second-source or alternate supplier of Rosuvastatin API — share grade, volumes and timeline to begin.
What is Rosuvastatin used for?
Rosuvastatin is HMG-CoA reductase inhibitor (statin), one of the most widely prescribed lipid-lowering statins worldwide, used in lowering LDL cholesterol and reducing cardiovascular risk.
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Need Rosuvastatin API?

Request specifications, samples or DMF/CEP documentation — or discuss a second-source or custom-synthesis programme.

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