Suppliers / Divi's Laboratories

Divi's Laboratories

India 2 duplicate records merged Updated 9 July 2026

Divi's Laboratories is an API and finished-dose manufacturer based in India. It holds 31 active US drug master files and 26 valid CEPs. Its filings concentrate with MINSA (CR) and CDSCO (India). Its GMP standing is certified by MFDS (Korea), EMA and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 14 November 2025 as NAI. Customs aggregates show $39.5M of exports covering 317 molecules to 63 destinations in 2025.

31
active US DMFs
26
valid CEPs
5
registered plants 2 with an FDA FEI number
20
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 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

  • 14 November 2025 NAI US FDA
  • 19 July 2024 VAI US FDA
  • 31 January 2020 NAI US FDA
  • 15 November 2019 NAI US FDA
  • 16 May 2018 NAI US FDA
  • 19 September 2017 VAI US FDA
  • 6 December 2016 OAI US FDA
  • 19 February 2016 NAI 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
Yadadri Bhuvanagiri District, India 3003131136
Visakhapatnam District, India 3004149463
Nalgonda, India Not on file
Visakhapatnam, India Not on file

What they file, and where

Molecule Regulators Docs
Carbidopa EDQM, PMDA (Japan), SFDA (Saudi Arabia), US FDA 10
Levodopa EDQM, SFDA (Saudi Arabia), US FDA 9
Levetiracetam EDQM, PMDA (Japan), SFDA (Saudi Arabia), US FDA 7
Dextromethorphan EDQM, SFDA (Saudi Arabia), US FDA 4
Gabapentin EDQM, SFDA (Saudi Arabia), US FDA 4
Naproxen EDQM, US FDA 4
Capecitabine EDQM, SFDA (Saudi Arabia) 3
Lacosamide EDQM, PMDA (Japan), US FDA 3
Mesalazine EDQM, PMDA (Japan), US FDA 3
Nabumetone EDQM, PMDA (Japan), US FDA 3
Show all 30 molecules on file
Phenylephrine EDQM, SFDA (Saudi Arabia) 3
Pregabalin EDQM, SFDA (Saudi Arabia), US FDA 3
Proguanil EDQM, SFDA (Saudi Arabia), US FDA 3
Quetiapine EDQM, SFDA (Saudi Arabia), US FDA 3
Diltiazem EDQM, US FDA 2
Iopamidol EDQM, US FDA 2
Irbesartan EDQM, US FDA 2
Rivaroxaban EDQM, US FDA 2
Ticagrelor EDQM, US FDA 2
Valsartan EDQM, US FDA 2
Venlafaxine EDQM, US FDA 2
Bosentan SFDA (Saudi Arabia) 1
Brivaracetam US FDA 1
Bupropion US FDA 1
Iohexol EDQM 1
Losartan US FDA 1
Losartan Potassium EDQM 1
Niacin US FDA 1
Olmesartan US FDA 1
Orlistat US FDA 1

Also appears on these molecule pages

Acyclovir contract manufacturing Amlodipine finished dose Capecitabine API Carbidopa contract manufacturing Desloratadine contract manufacturing Dextromethorphan contract manufacturing Diltiazem contract manufacturing Gabapentin contract manufacturing Irbesartan contract manufacturing Lacosamide API Levetiracetam contract manufacturing Levodopa contract manufacturing
Show 20 more molecule pages
Loratadine contract manufacturing Losartan contract manufacturing Mesalamine API Mesalazine API Nabumetone contract manufacturing Naproxen contract manufacturing Olmesartan contract manufacturing Phenylephrine contract manufacturing Phenytoin contract manufacturing Pregabalin contract manufacturing Quetiapine contract manufacturing Rivaroxaban API Sumatriptan API Tamsulosin contract manufacturing Telmisartan contract manufacturing Ticagrelor API Valsartan contract manufacturing Venlafaxine contract manufacturing Vigabatrin contract manufacturing Zolpidem contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 17 None
CDSCO (India) 3 None
MFDS (Korea) None 4
EMA None 3
US FDA None 2
MHRA (UK) None 1

Scale

Year Revenue Exports Destinations
2025 Not reported $39.5M 63
2024 Not reported $71.3M 60
2023 Not reported $71.5M 58
2022 Not reported $211.8M 73

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

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Open risk flags

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 14 November 2025.

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