Suppliers / Nosch Labs

Nosch Labs

India 3 duplicate records merged Updated 9 July 2026

Nosch Labs is an API and finished-dose manufacturer based in India. It holds 32 valid CEPs across a filed portfolio of 26 molecules. Its filings concentrate with INVIMA (CO), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by EMA, MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 September 2024 as VAI.

0
active US DMFs
32
valid CEPs
4
registered plants 1 with an FDA FEI number
21
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 13 September 2024 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Hyderabad, India Not on file
Choutuppal Mandal, India Not on file
Telangana, India Not on file
Hyderabad, India 3009250999

What they file, and where

Molecule Regulators Docs
Esomeprazole EDQM, SFDA (Saudi Arabia) 4
Itraconazole EDQM 4
Esomeprazole Magnesium Dihydrate EDQM 3
Olanzapine EDQM, SFDA (Saudi Arabia) 3
Omeprazole EDQM, SFDA (Saudi Arabia) 3
Dapoxetine SFDA (Saudi Arabia) 2
Duloxetine Hydrochlorie SFDA (Saudi Arabia) 2
Lansoprazole EDQM 2
Pantoprazole EDQM, SFDA (Saudi Arabia) 2
Rosuvastatin EDQM, SFDA (Saudi Arabia) 2
Show all 26 molecules on file
Ciprofibrate EDQM 1
Doxazosin Mesilate EDQM 1
Duloxetine EDQM 1
Duloxetine Hydrochloride EDQM 1
Fenofibrate EDQM 1
Fluoxetine EDQM 1
Moxifloxacin EDQM 1
Pantoprazole Sodium Sesquihydrate EDQM 1
Quetiapine EDQM 1
Quetiapine Fumarate EDQM 1
Rabeprazole EDQM 1
Rivaroxaban EDQM 1
Sertraline EDQM 1
Sumatriptan EDQM 1
Tamsulosin SFDA (Saudi Arabia) 1
Terconazole EDQM 1

Also appears on these molecule pages

Ciprofibrate API Dapoxetine API Doxazosin Mesilate API Duloxetine API Esomeprazole API Fenofibrate API Fluoxetine API Itraconazole API Lansoprazole API Molnupiravir finished dose Moxifloxacin API Olanzapine API
Show 9 more molecule pages
Omeprazole API Pantoprazole API Rabeprazole API Rosuvastatin API Sertraline API Sumatriptan API Tamsulosin API Quetiapine API Rivaroxaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
INVIMA (CO) 6 None
ARCSA (EC) 5 None
MINSA (CR) 3 None
JFDA (JO) 3 None
CDSCO (India) 2 None
DIGEMAPS (DO) 2 None
EMA None 2
MFDS (Korea) None 2
US FDA None 1

Questions about Nosch Labs

Does Nosch Labs hold a US DMF or a CEP?
Nosch Labs holds 32 valid CEPs. 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 Nosch Labs FDA-registered?
One site operated by Nosch Labs 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.
How did Nosch Labs's last inspection go?
The most recent inspection on record closed on 13 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Nosch Labs manufacture?
4 registered sites are on record, in India (Hyderabad, Choutuppal Mandal and Telangana among others). Every site is listed on this page with the register it came from.
What does Nosch Labs make?
26 molecules are on record against Nosch Labs, including Esomeprazole, Itraconazole, Esomeprazole Magnesium Dihydrate and Olanzapine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nosch Labs's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea) and US FDA. 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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Open risk flags

  • The most recent inspection outcome was VAI, on 13 September 2024.

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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