Suppliers / Lewens Labs

Lewens Labs

India Updated 9 July 2026

Lewens Labs is an API and finished-dose manufacturer based in India. It holds one active US drug master file. Its GMP standing is certified by CDSCO (India).

1
active US DMFs
0
valid CEPs
2
registered plants
4
filings across 1 regulators

Registered plants

Site FDA FEI
dahej bharuch, India Not on file
Dahej, India Not on file

What they file, and where

Molecule Regulators Docs
Rosuvastatin US FDA 1

Also appears on these molecule pages

Iguratimod finished dose Relugolix finished dose Rosuvastatin API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 4 2

Questions about Lewens Labs

Does Lewens Labs hold a US DMF or a CEP?
Lewens Labs holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does Lewens Labs manufacture?
2 registered sites are on record, in India (Dahej Bharuch and Dahej). Every site is listed on this page with the register it came from.
What does Lewens Labs make?
1 molecule is on record against Lewens Labs, including Rosuvastatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Lewens Labs's GMP?
Current GMP certificates are on record from CDSCO (India). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

Checking Lewens Labs?

Ask Fred what the record holds on Lewens Labs, including filings and inspection history.

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Comparable suppliers

Acharya Chemicals also in India Akshat Pharma also in India Alkaloids Bioactives also in India Anlon Healthcare also in India Aparna Pharmaceuticals also in India

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates