Nosch Labs

India 3 duplicate records merged Updated 9 July 2026

Nosch Labs is an API 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 JFDA (JO). 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.

active US DMFs

valid CEPs

registered plants 1 with an FDA FEI number

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

Duloxetine API Esomeprazole API Fenofibrate API Fluoxetine API Itraconazole API Lansoprazole API Moxifloxacin API Olanzapine API Omeprazole API Pantoprazole API Rosuvastatin API Sertraline API

Show 4 more molecule pages

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
JFDA (JO)	3	None
MINSA (CR)	3	None
DIGEMAPS (DO)	2	None
CDSCO (India)	2	None
EMA	None	2
MFDS (Korea)	None	2
US FDA	None	1

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Open risk flags

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

Sources on this page

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