Suppliers / Dr Reddy's Laboratories

Dr Reddy's Laboratories

India RDY 62 employees reconciled across 37 public records · 16 entities Updated 9 July 2026

Dr Reddy's Laboratories is an API and finished-dose manufacturer based in India. It holds 279 active US drug master files and 90 valid CEPs. Its filings concentrate with US FDA, Health Canada and AIFA (IT). Its GMP standing is certified by ANVISA (Brazil), EMA and US FDA, among 10 authorities. Its most recent recorded inspection, by US FDA, closed on 14 November 2025 as NAI. Customs aggregates show $72.3M of exports covering 894 molecules to 64 destinations in 2025.

279
active US DMFs
90
valid CEPs
49
registered plants 13 with an FDA FEI number
2,840
filings across 36 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
6 of 6 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
  • 18 July 2025 VAI US FDA
  • 24 May 2025 VAI US FDA
  • 19 November 2024 VAI US FDA
  • 20 September 2024 NAI US FDA
  • 7 June 2024 VAI US FDA
  • 17 May 2024 VAI US FDA
  • 8 December 2023 VAI US FDA
  • 27 October 2023 VAI US FDA
  • 19 July 2023 NAI US FDA
  • 16 June 2023 NAI US FDA
  • 12 May 2023 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, United Arab Emirates Not on file
Visakhapatnam, United Arab Emirates Not on file
Visalhapatnam, United Arab Emirates Not on file
São Paulo, Brazil Not on file
SAO PAULO, Brazil Not on file
Basel, Switzerland Not on file

34 further sites are on record.

What they file, and where

Molecule Regulators Docs
Atorvastatin SFDA (Saudi Arabia), US FDA 9
Naproxen EDQM, PMDA (Japan), US FDA 8
Omeprazole EDQM, US FDA 8
Empagliflozin SFDA (Saudi Arabia), US FDA 7
Rivaroxaban EDQM, SFDA (Saudi Arabia), US FDA 7
Sitagliptin EDQM, SFDA (Saudi Arabia), US FDA 7
Clopidogrel EDQM, SFDA (Saudi Arabia), US FDA 6
Esomeprazole EDQM, SFDA (Saudi Arabia), US FDA 6
Ondansetron EDQM, SFDA (Saudi Arabia), US FDA 6
Ciprofloxacin EDQM, SFDA (Saudi Arabia), US FDA 5
Show all 40 molecules on file
Montelukast EDQM, SFDA (Saudi Arabia), US FDA 5
Moxifloxacin EDQM, SFDA (Saudi Arabia), US FDA 5
Sumatriptan EDQM, SFDA (Saudi Arabia), US FDA 5
Ticagrelor EDQM, SFDA (Saudi Arabia), US FDA 5
Glimepiride EDQM, SFDA (Saudi Arabia), US FDA 4
Ketorolac EDQM, SFDA (Saudi Arabia), US FDA 4
Lenalidomide SFDA (Saudi Arabia), US FDA 4
Levetiracetam EDQM, SFDA (Saudi Arabia), US FDA 4
Pantoprazole EDQM, SFDA (Saudi Arabia), US FDA 4
Pregabalin EDQM, SFDA (Saudi Arabia), US FDA 4
Rivastigmine EDQM, US FDA 4
Valsartan EDQM, SFDA (Saudi Arabia), US FDA 4
Voriconazole EDQM, US FDA 4
Amlodipine EDQM, SFDA (Saudi Arabia), US FDA 3
Atorvastatin Calcium EDQM 3
Cabazitaxel SFDA (Saudi Arabia), US FDA 3
Cabozantinib US FDA 3
Capecitabine EDQM, SFDA (Saudi Arabia), US FDA 3
Cetirizine Dihydrochloride EDQM, SFDA (Saudi Arabia) 3
Dapagliflozin US FDA 3
Decitabine SFDA (Saudi Arabia), US FDA 3
Desloratadine EDQM, SFDA (Saudi Arabia), US FDA 3
Dimethyl SFDA (Saudi Arabia) 3
Docetaxel EDQM, SFDA (Saudi Arabia), US FDA 3
Dutasteride SFDA (Saudi Arabia), US FDA 3
Enalapril EDQM, SFDA (Saudi Arabia), US FDA 3
Escitalopram EDQM, SFDA (Saudi Arabia), US FDA 3
Finasteride EDQM, US FDA 3
Gemcitabine EDQM, SFDA (Saudi Arabia), US FDA 3
Icatibant SFDA (Saudi Arabia), US FDA 3

Also appears on these molecule pages

Show 336 more molecule pages
Amphetamine finished dose Anastrozole API Apalutamide API Apixaban API Apremilast contract manufacturing Aprepitant API Arformoterol finished dose Aripiprazole finished dose Asenapine API Atazanavir finished dose Atomoxetine API Atorvastatin contract manufacturing Atropine finished dose Axitinib finished dose Azacitidine API Bempedoic Acid API Benazepril finished dose Bendamustine API Benzatropine API Bisacodyl finished dose Bivalirudin API Bortezomib API Bosutinib finished dose Brimonidine finished dose Buprenorphine finished dose Cabazitaxel API Cabozantinib API Caffeine finished dose Calcium Carbonate finished dose Canagliflozin API Capecitabine API Carboprost finished dose Carfilzomib API Carmustine finished dose Carvedilol API Caspofungin finished dose Cefazolin finished dose Celecoxib API Cetirizine API Chlorpromazine finished dose Ciclosporin finished dose Cinacalcet API Ciprofloxacin API Citalopram API Clarithromycin finished dose Clobetasol finished dose Clofarabine finished dose Clonidine finished dose Clopidogrel API Clozapine finished dose Codeine finished dose Colesevelam finished dose Crisaborole finished dose Cyclosporine finished dose Dabigatran Etexilate API Dabigatran Etexilate Mesilate API Dapagliflozin API Daptomycin finished dose Darunavir finished dose Dasatinib API Decitabine API Deferasirox finished dose Deferiprone finished dose Desloratadine API Desmopressin finished dose Desogestrel finished dose Desvenlafaxine finished dose Deucravacitinib API Dexamethasone finished dose Dexlansoprazole API Dexmedetomidine finished dose Dextromethorphan finished dose Diazepam finished dose Diltiazem finished dose Dimethyl API Diphenhydramine finished dose Dipyridamole finished dose Dobutamine finished dose Docetaxel API Docosanol finished dose Dofetilide finished dose Domperidone finished dose Donepezil API Doxazosin API Doxazosin Mesilate API Doxercalciferol finished dose Doxorubicin finished dose Doxycycline finished dose Drospirenone finished dose Duloxetine API Dutasteride API Edaravone API Edoxaban API Efavirenz finished dose Elagolix API Eliglustat API Eltrombopag finished dose Empagliflozin API Emtricitabine finished dose Enalapril API Enzalutamide API Ephedrine finished dose Eribulin API Erlotinib finished dose Ertapenem finished dose Erythromycin finished dose Escitalopram API Eslicarbazepine API Esomeprazole API Eszopiclone API Ethinylestradiol finished dose Etonogestrel finished dose Everolimus finished dose Exemestane finished dose Ezetimibe API Famotidine API Favipiravir finished dose Febuxostat API Fenofibrate finished dose Fentanyl finished dose Ferric Carboxymaltose API Fesoterodine finished dose Fexofenadine API Finasteride API Finerenone API Fingolimod API Fluconazole API Flumazenil finished dose Fluorouracil finished dose Fluoxetine API Fondaparinux API Formoterol finished dose Fosaprepitant API Fulvestrant finished dose Galantamine API Gatifloxacin API Gemcitabine API Glatiramer API Gliclazide finished dose Glimepiride API Glycopyrronium finished dose Granisetron API Heparin finished dose Hydrochlorothiazide finished dose Hydroxychloroquine API Hydroxyzine finished dose Ibandronate API Ibandronic Acid API Ibrutinib API Ibuprofen finished dose Icatibant API Icosapent Ethyl finished dose Imatinib API Irbesartan API Irinotecan finished dose Itraconazole finished dose Ivermectin finished dose Ketorolac Tromethamine API Lacosamide finished dose Lamivudine finished dose Lamotrigine API Lanreotide API Lansoprazole API Lenalidomide API Lenvatinib API Letrozole API Leucovorin finished dose Levetiracetam API Levocetirizine API Levodopa finished dose Levofloxacin API Levonorgestrel finished dose Levothyroxine finished dose Lidocaine finished dose Lifitegrast API Linaclotide finished dose Linagliptin API Linezolid API Liraglutide API Loperamide finished dose Losartan API Lubiprostone API Lurasidone API Mavacamten API Melphalan finished dose Memantine API Metformin finished dose Methocarbamol finished dose Methylphenidate finished dose Methylprednisolone finished dose Metoprolol API Midostaurin API Milnacipran API Minoxidil finished dose Mirabegron API Molnupiravir finished dose Monelukast API Montelukast API Morphine finished dose Moxifloxacin API Mycophenolate Mofetil finished dose Naloxone finished dose Naproxen API Nateglinide API Nelarabine finished dose Nicotine finished dose Nilotinib API Nintedanib finished dose Niraparib API Nitrofurantoin finished dose Nitroglycerin finished dose Nizatidine API Norethisterone API Nystatin finished dose Obeticholic Acid API Ofloxacin finished dose Olanzapine API Olaparib API Omeprazole API Ondansetron API Oxaliplatin finished dose Oxycodone finished dose Oxytocin finished dose Paclitaxel finished dose Palbociclib API Paliperidone API Palonosetron API Pantoprazole API Paracetamol finished dose Paricalcitol finished dose Pazopanib API Pemetrexed API Pemetrexed Disodium API Penicillamine finished dose Pentosan Polysulfate API Permethrin API Phenylephrine finished dose Phylloquinone finished dose Pioglitazone API Pirfenidone finished dose Plerixafor API Pomalidomide API Posaconazole API Prasugrel API Pravastatin finished dose Prednisone finished dose Pregabalin API Primidone API Progesterone finished dose Propofol finished dose Pseudoephedrine finished dose Quetiapine API Rabeprazole API Raloxifene API Raltegravir finished dose Ramipril API Ranitidine API Ranolazine API Rasagiline API Regadenoson finished dose Regorafenib finished dose Relugolix API Repaglinide API Risperidone API Ritonavir API Rivaroxaban API Rivastigmine API Rizatriptan API Ropinirole API Ruxolitinib API Sacubitril API Sacubitril/Valsartan API Saxagliptin API Semaglutide API Sertraline API Sevelamer finished dose Sildenafil API Simvastatin finished dose Siponimod API Sitagliptin API Sodium Alendronate API Solifenacin API Sorafenib finished dose Succinylcholine finished dose Sugammadex API Sulindac API Sumatriptan API Sunitinib finished dose Tacrolimus finished dose Tadalafil API Tafamidis API Tamoxifen finished dose Tapentadol finished dose Telmisartan API Tenofovir Disoproxil finished dose Terbinafine API Terbutaline finished dose Teriflunomide finished dose Teriparatide finished dose Testosterone API Tetrabenazine finished dose Thiotepa finished dose Ticagrelor API Timolol finished dose Tirzepatide API Tizanidine API Tobramycin finished dose Tofacitinib API Tolterodine API Tolvaptan finished dose Topiramate API Tranexamic Acid finished dose Travoprost API Treprostinil API Triethylenetetramine finished dose Trimethoprim finished dose Triptorelin finished dose Valganciclovir API Valsartan API Vardenafil API Varenicline API Vasopressin finished dose Venetoclax API Venlafaxine API Vigabatrin finished dose Vilazodone API Vildagliptin finished dose Vinorelbine finished dose Voclosporin API Vonoprazan API Voriconazole API Vortioxetine finished dose Ziprasidone API Zoledronic Acid API Zolmitriptan API Zolpidem API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 691 10
Health Canada 409 None
AIFA (IT) 330 None
ANVISA (Brazil) 321 29
MHRA (UK) 185 4
CDSCO (India) 182 8
EMA None 18
MFDS (Korea) None 6
INVIMA (CO) None 2
TMDA (TZ) None 1
EAEU_EEC None 1
GOSPHARMNADZOR (BY) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $20.1M 49
2025 $3.8B $72.3M 64
2024 $3.4B Not reported Not reported
2023 $3.0B Not reported Not reported

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

Questions about Dr Reddy's Laboratories

Does Dr Reddy's Laboratories hold a US DMF or a CEP?
Dr Reddy's Laboratories holds 279 active US drug master files and 90 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 Dr Reddy's Laboratories FDA-registered?
13 sites operated by Dr Reddy'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 Dr Reddy'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). 24 inspections are on file.
Where does Dr Reddy's Laboratories manufacture?
40 registered sites are on record, in United Arab Emirates, Brazil, Switzerland and Colombia (Hyderabad, Visakhapatnam and Visalhapatnam among others). Every site is listed on this page with the register it came from.
What does Dr Reddy's Laboratories make?
40 molecules are on record against Dr Reddy's Laboratories, including Atorvastatin, Naproxen, Omeprazole and Empagliflozin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Dr Reddy's Laboratories's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, US FDA, CDSCO (India), MFDS (Korea) and 5 more. 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

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

Comparable suppliers

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
Company filings
Revenue as reported