Suppliers / Lactose (India)

Lactose (India)

India 2 duplicate records merged Updated 9 July 2026

Lactose (India) is an API manufacturer based in India. It holds one active US drug master file and one valid CEP. Its filings concentrate with NAFDAC (NG), UZPHARM (UZ) and MINSA (CR). Its GMP standing is certified by CDSCO (India), NAFDAC (NG) and EAEU_EEC. Customs aggregates show $3.4M of exports covering 46 molecules to 9 destinations in 2025.

1
active US DMFs
1
valid CEPs
5
registered plants 1 with an FDA FEI number
5
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
EU GMP
0 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Vadodara, India 3014659521
Mumbai, India Not on file
e poicha rania tal savli poicha vadodara, India Not on file
a rania tal savlipoichavadoda ra 391 780, India Not on file
RICT -VADODARA, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Lactulose EDQM, US FDA 2

Also appears on these molecule pages

Lactulose API

Filings and GMP by regulator

Regulator Filings GMP certificates
NAFDAC (NG) 3 2
UZPHARM (UZ) 1 None
MINSA (CR) 1 None
CDSCO (India) None 3
EAEU_EEC None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $331K 3
2025 Not reported $3.4M 9
2024 Not reported $1.2M 7
2023 Not reported $1.5M 7

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Lactose (India)

Does Lactose (India) hold a US DMF or a CEP?
Lactose (India) holds 1 active US drug master file and 1 valid CEP. 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.
Is Lactose (India) FDA-registered?
One site operated by Lactose (India) carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does Lactose (India) manufacture?
5 registered sites are on record, in India and Nigeria (Vadodara, Mumbai and E Poicha Rania Tal Savli Poicha Vadodara among others). Every site is listed on this page with the register it came from.
What does Lactose (India) make?
1 molecule is on record against Lactose (India), including Lactulose. Each links through to that molecule's full manufacturer list.
Which regulators recognise Lactose (India)'s GMP?
Current GMP certificates are on record from CDSCO (India), NAFDAC (NG) and EEC (Eurasian Economic Union). 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.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts