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
Yadadri Bhuvanagiri District, India 3003131136
Visakhapatnam District, India 3004149463
Hyderabad, India Not on file
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 Bosentan API Brivaracetam API Bupropion API Capecitabine API Carbidopa contract manufacturing Desloratadine contract manufacturing Dextromethorphan contract manufacturing Diltiazem contract manufacturing Favipiravir finished dose Gabapentin contract manufacturing
Show 29 more molecule pages
Iohexol API Iopamidol contract manufacturing Irbesartan contract manufacturing Lacosamide API Levetiracetam contract manufacturing Levodopa contract manufacturing Loratadine contract manufacturing Losartan contract manufacturing Mesalamine API Mesalazine API Molnupiravir finished dose Nabumetone contract manufacturing Naproxen contract manufacturing Olmesartan contract manufacturing Orlistat API Phenylephrine contract manufacturing Phenytoin contract manufacturing Pregabalin contract manufacturing Proguanil 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.

Questions about Divi's Laboratories

Does Divi's Laboratories hold a US DMF or a CEP?
Divi's Laboratories holds 31 active US drug master files and 26 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 Divi's Laboratories FDA-registered?
2 sites operated by Divi's Laboratories carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Divi's Laboratories's last inspection go?
The most recent inspection on record closed on 14 November 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file, of which 1 closed as OAI.
Where does Divi's Laboratories manufacture?
5 registered sites are on record, in India (Yadadri Bhuvanagiri District, Visakhapatnam District and Hyderabad among others). Every site is listed on this page with the register it came from.
What does Divi's Laboratories make?
30 molecules are on record against Divi's Laboratories, including Carbidopa, Levodopa, Levetiracetam and Dextromethorphan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Divi's Laboratories's GMP?
Current GMP certificates are on record from MFDS (Korea), EMA, US FDA and MHRA (UK). 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

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

Comparable suppliers

Hetero shares 18 molecules Apitoria Pharma shares 16 molecules Zydus Lifesciences shares 13 molecules Dr Reddy's Laboratories shares 12 molecules Alembic Pharmaceuticals shares 12 molecules

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
Customs aggregates
Export values, molecule and destination counts