Register entryHome medical equipment
- Registered sites
- 18
- Active NDC listings
- 132
- Labeller names
- 2
- Live patents
- 8
- Countries
- 4
- Base
- India
Authorisation
Registered operations
Analytical testing18Labelling14Finished drug manufacture15Packaging14sterilize3
Sites
Registered establishments
18| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Alphapharm Pty LtdRegistrant: Viatris Inc. | 15 Garnet St, Carole Park, QLD 4300, Australia (AUS) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002806388754819436 |
| Mylan Laboratories LimitedRegistrant: Viatris Inc. | (OTL), Plot No. 284-B, Bommasandra Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, Karnataka 560105, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3007512701676159830 |
| Mylan Laboratories LimitedRegistrant: Viatris Inc. | Specialty Formulation Facility, Plot No: 284B/1, 289-292 Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bengaluru, Karnataka 560105, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3007648351677605290 |
| Mylan Laboratories LimitedRegistrant: Viatris Inc. | (FDF-2) H-12 & H-13, MIDC, Waluj, Chhatrapati Sambhajinagar, Maharashtra State 431136, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3008316970863996098 |
| Mylan Laboratories LimitedRegistrant: Viatris Inc. | (FDF-3) Plot No. 11, 12 &13, Indore Special Economic Zone Pharma Zone, Phase II, Sector III Pithampur, District - Dhar, Madhya Pradesh 454775, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3010453141859649433 |
| Mylan Laboratories LimitedRegistrant: Viatris Inc. | Hosur Steriles Facility, Plot No. 13A, 14, & CP 2, Sipcot Phase II, Krishnagiri Main Road, Hosur, Tamil Nadu 635130, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3008255419650658052 |
| Mylan Laboratories LimitedRegistrant: Viatris Inc. | Clinical Research Centre, Saradhi Chambers, A-4 Rukminipuri Near Polomi Hospital Main Road, Dr AS Rao Nagar, Hyderabad, Telangana 500062, India (IND) | Analytical testing | 3006355432650438166 |
| Mylan Laboratories LimitedRegistrant: Viatris Inc. | R & D Center, Plot No 34-A, ANRICH Industrial Estate, Bollaram, Jinnaram Mandal, Sangareddy District, Hyderabad, Telangana 502325, India (IND) | Analytical testing | 3007720135675595676 |
| Mylan Laboratories LimitedRegistrant: Viatris Inc. | (FDF-1), F-4 and F-12, Malegaon MIDC, Sinnar, Nasik District, Nashik, Maharashtra 422113, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005587313725584960 |
| McDermott Laboratories Limited trading as Mylan Dublin RespiratoryRegistrant: Viatris Inc. | Unit 25 Baldoyle Industrial Estate, Grange Road, Dublin, , Ireland (IRL) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3011420468986117174 |
| Mylan TeorantaRegistrant: Viatris Inc. | Inverin, Co. Galway, , Ireland (IRL) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002806521986298925 |
| Viatris Pharmaceuticals LLCRegistrant: Viatris Inc. | Road #2 Km 58.2, Barceloneta, Puerto Rico (PR) 00617, United States (USA) | Analytical testing, Finished drug manufacture | 2627208829084545 |
| Mylan Pharmaceuticals Inc.Registrant: Viatris Inc. | 3711 Collins Ferry Road, Morgantown, West Virginia (WV) 26505, United States (USA) | Analytical testing | 1110315093518574 |
| DPT Laboratories, Ltd.Registrant: Viatris Inc. | 5303 Distribution Drive, San Antonio, Texas (TX) 78218, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 1000117684832224591 |
| DPT Laboratories, Ltd.Registrant: Viatris Inc. | 307 E. Josephine Street, San Antonio, Texas (TX) 78215, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 1628114832224526 |
| DPT Laboratories, Ltd.Registrant: Viatris Inc. | 3300 Research Plaza, San Antonio, Texas (TX) 78235, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005023061832224690 |
| Mylan Technologies Inc.Registrant: Viatris Inc. | 110 Lake St, St. Albans, Vermont (VT) 05478, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 1220747063790265 |
| Viatris Pharmaceuticals LLCRegistrant: Viatris Inc. | Road 689 Km 1.9, Vega Baja, Puerto Rico (PR) 00693, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 2623619829084552 |
Catalogue
Drug listings by form and route
132132 active NDC listings: 112 human prescription drug, 15 bulk ingredient, 4 drug for further processing, 1 human otc drug. By marketing category: NDA 101, BULK INGREDIENT 15, UNAPPROVED DRUG OTHER 5, ANDA 4, EXPORT ONLY 4.
| Dosage form | NDCs |
|---|---|
| tablet | 28 |
| tablet, film coated | 24 |
| capsule | 20 |
| powder | 15 |
| capsule, extended release | 5 |
| solution | 5 |
| tablet, film coated, extended release | 5 |
| aerosol, foam | 4 |
| injection | 4 |
| patch | 4 |
| tablet, extended release | 3 |
| suspension | 2 |
| tablet, multilayer, extended release | 2 |
| capsule, gelatin coated | 1 |
| gel, metered | 1 |
| Route | NDCs |
|---|---|
| oral | 90 |
| intramuscular | 5 |
| respiratory (inhalation) | 4 |
| topical | 4 |
| transdermal | 4 |
| sublingual | 3 |
| rectal | 2 |
| intravenous | 1 |
| nasal | 1 |
| ophthalmic | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| viatris specialty llc | 113 |
| viatris pharmaceuticals llc | 19 |
Exclusivity
Patents and exclusivities
8| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9597281 | EDLUARzolpidem tartrate | use | Apr 2027 |
| 8071073 | ASTEPROazelastine hydrochloride | product | Jun 2028 |
| 8869794 | TOBI PODHALERtobramycin | product | Sept 2028 |
| 10207066 | TOBI PODHALERtobramycin | product | Nov 2030 |
| 9265720 | EDLUARzolpidem tartrate | use | Feb 2031 |
Catalogue
Marketed products
135Showing 132 of 135.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Amlodipine Besylate | powder | 65427-003BULK INGREDIENT |
| - | Azithromycin | powder | 65427-310BULK INGREDIENT |
| - | Azithromycin Dihydrate | powder | 65427-014BULK INGREDIENT |
| CELEBREX | Celecoxib | capsule, oral | 58151-082NDA |
| CELEBREX | Celecoxib | capsule, oral | 58151-083NDA |
| CELEBREX | Celecoxib | capsule, oral | 58151-084NDA |
| CELEBREX | Celecoxib | capsule, oral | 58151-085NDA |
| CIMDUO | Lamivudine and Tenofovir Disoproxil Fumarate | tablet, film coated, oral | 49502-450NDA |
| Caduet | amlodipine and atorvastatin | tablet, film coated, oral | 58151-062NDA |
| Caduet | amlodipine and atorvastatin | tablet, film coated, oral | 58151-063NDA |
| Caduet | amlodipine and atorvastatin | tablet, film coated, oral | 58151-064NDA |
| Caduet | amlodipine and atorvastatin | tablet, film coated, oral | 58151-065NDA |
| Caduet | amlodipine and atorvastatin | tablet, film coated, oral | 58151-066NDA |
| Caduet | amlodipine and atorvastatin | tablet, film coated, oral | 58151-067NDA |
| Cardura | doxazosin | tablet, oral | 58151-074NDA |
| Cardura | doxazosin | tablet, oral | 58151-075NDA |
| Cardura | doxazosin | tablet, oral | 58151-076NDA |
| Cardura | doxazosin | tablet, oral | 58151-077NDA |
| Cardura XL | doxazosin mesylate | tablet, film coated, extended release, oral | 58151-078NDA |
| Cardura XL | doxazosin mesylate | tablet, film coated, extended release, oral | 58151-079NDA |
| Cortifoam | hydrocortisone acetate | aerosol, foam, topical | 0037-6830NDA |
| DILANTIN | Extended Phenytoin Sodium | capsule, extended release, oral | 58151-110ANDA |
| DILANTIN | Extended Phenytoin Sodium | capsule, extended release, oral | 58151-118ANDA |
| DYMISTA | Azelastine Hydrochloride and Fluticasone Propionate | spray, metered, nasal | 0037-0245NDA |
| Depen | Penicillamine | tablet, oral | 0037-4401NDA |
| Detrol | tolterodine tartrate | tablet, film coated, oral | 58151-099NDA |
| Dilantin-125 | Phenytoin | suspension, oral | 58151-115NDA |
| Dipentum | olsalazine sodium | capsule, gelatin coated, oral | 0037-6860NDA |
| - | Doxazosin Mesylate | powder | 65427-018BULK INGREDIENT |
| - | Doxazosin mesylate | tablet, multilayer, extended release | 65427-012EXPORT ONLY |
| - | Doxazosin mesylate | tablet, multilayer, extended release | 65427-016EXPORT ONLY |
| ELESTRIN | ESTRADIOL | gel, metered, topical | 0037-4801NDA |
| EMSAM | selegiline | patch, transdermal | 49502-900NDA |
| EMSAM | selegiline | patch, transdermal | 49502-901NDA |
| EMSAM | selegiline | patch, transdermal | 49502-902NDA |
| EPIFOAM | pramoxine hydrochloride and hydrocortisone acetate | aerosol, foam, topical | 0037-6824ANDA |
| EPIPEN | epinephrine | injection, intramuscular | 49502-500NDA |
| EPIPEN JR | epinephrine | injection, intramuscular | 49502-501NDA |
| Edluar | Zolpidem Tartrate | tablet, oral | 0037-6010NDA |
| Edluar | Zolpidem Tartrate | tablet, oral | 0037-6050NDA |
| Effexor XR | VENLAFAXINE HYDROCHLORIDE | capsule, extended release, oral | 58151-125NDA |
| Effexor XR | VENLAFAXINE HYDROCHLORIDE | capsule, extended release, oral | 58151-126NDA |
| Effexor XR | VENLAFAXINE HYDROCHLORIDE | capsule, extended release, oral | 58151-127NDA |
| Epinephrine | Epinephrine | injection, intramuscular | 49502-101NDA AUTHORIZED GENERIC |
| Epinephrine | Epinephrine | injection, intramuscular | 49502-102NDA AUTHORIZED GENERIC |
| - | Exemestane | powder | 65427-030BULK INGREDIENT |
| Felbatol | felbamate | tablet, oral | 0037-0430NDA |
| Felbatol | felbamate | tablet, oral | 0037-0431NDA |
| Gastrocrom | cromolyn sodium | liquid, oral | 0037-0678NDA |
| Geodon | ziprasidone | capsule, oral | 58151-131NDA |
| Geodon | ziprasidone | capsule, oral | 58151-132NDA |
| Geodon | ziprasidone | capsule, oral | 58151-133NDA |
| Geodon | ziprasidone | capsule, oral | 58151-134NDA |
| Geodon | ziprasidone mesylate | injection, powder, lyophilized, for solution, intramuscular | 58151-137NDA |
| Gwyn Lo | norelgestromin and ethinyl estradiol | patch, transdermal | 49502-627NDA |
| Inspra | eplerenone | tablet, film coated, oral | 58151-142NDA |
| Inspra | eplerenone | tablet, film coated, oral | 58151-143NDA |
| - | Latanoprost | powder | 65427-007BULK INGREDIENT |
| Levbid | hyoscyamine sulfate | tablet, extended release, oral | 68220-115UNAPPROVED DRUG OTHER |
| Levsin | hyoscyamine sulfate | tablet, oral | 68220-112UNAPPROVED DRUG OTHER |
| Levsin SL | hyoscyamine sulfate | tablet, orally disintegrating, oral | 68220-113UNAPPROVED DRUG OTHER |
| - | Linezolid | powder | 65427-821BULK INGREDIENT |
| Lipitor | atorvastatin calcium | tablet, film coated, oral | 58151-155NDA |
| Lipitor | atorvastatin calcium | tablet, film coated, oral | 58151-156NDA |
| Lipitor | atorvastatin calcium | tablet, film coated, oral | 58151-157NDA |
| Lipitor | atorvastatin calcium | tablet, film coated, oral | 58151-158NDA |
| Lyrica | PREGABALIN | capsule, oral | 58151-236NDA |
| Lyrica | PREGABALIN | capsule, oral | 58151-237NDA |
| Lyrica | PREGABALIN | capsule, oral | 58151-238NDA |
| Lyrica | PREGABALIN | capsule, oral | 58151-239NDA |
| Lyrica | PREGABALIN | capsule, oral | 58151-240NDA |
| Lyrica | PREGABALIN | capsule, oral | 58151-241NDA |
| Lyrica | PREGABALIN | capsule, oral | 58151-242NDA |
| Lyrica | PREGABALIN | capsule, oral | 58151-243NDA |
| Lyrica | PREGABALIN | solution, oral | 58151-244NDA |
| Lyrica CR | PREGABALIN | tablet, film coated, extended release, oral | 58151-245NDA |
| Lyrica CR | PREGABALIN | tablet, film coated, extended release, oral | 58151-246NDA |
| Lyrica CR | PREGABALIN | tablet, film coated, extended release, oral | 58151-247NDA |
| Neurontin | gabapentin | capsule, oral | 58151-281NDA |
| Neurontin | gabapentin | capsule, oral | 58151-282NDA |
| Neurontin | gabapentin | capsule, oral | 58151-283NDA |
| Neurontin | gabapentin | tablet, film coated, oral | 58151-284NDA |
| Neurontin | gabapentin | tablet, film coated, oral | 58151-285NDA |
| Neurontin | gabapentin | solution, oral | 58151-290NDA |
| Nitrostat | nitroglycerin | tablet, sublingual | 58151-309NDA |
| Nitrostat | nitroglycerin | tablet, sublingual | 58151-310NDA |
| Nitrostat | nitroglycerin | tablet, sublingual | 58151-311NDA |
| Norvasc | amlodipine besylate | tablet, oral | 58151-353NDA |
| Norvasc | amlodipine besylate | tablet, oral | 58151-354NDA |
| Norvasc | amlodipine besylate | tablet, oral | 58151-355NDA |
| NuLev | hyoscyamine sulfate | tablet, chewable, oral | 68220-118UNAPPROVED DRUG OTHER |
| PROCTOFOAM HC | pramoxine hydrochloride hydrocortisone acetate | aerosol, foam, topical | 0037-6822ANDA |
| PROCTOFOAM NS | pramoxine hydrochloride | aerosol, foam, rectal | 0037-6823OTC MONOGRAPH DRUG |
| - | Parecoxib sodium | powder | 65427-017BULK INGREDIENT |
| Perforomist | formoterol fumarate dihydrate | solution, respiratory (inhalation) | 49502-605NDA |
| Pretomanid | Pretomanid | tablet, oral | 49502-476NDA |
| Relpax | eletriptan hydrobromide | tablet, oral | 58151-367NDA |
| Relpax | eletriptan hydrobromide | tablet, oral | 58151-368NDA |
| Revatio | sildenafil citrate | powder, for suspension, oral | 58151-385NDA |
| Revatio | sildenafil citrate | injection, solution, intravenous | 58151-395NDA |
| Revatio | sildenafil citrate | tablet, film coated, oral | 58151-402NDA |
| Rowasa | mesalamine | suspension, rectal | 0037-0066NDA |
| SYMFI | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | tablet, film coated, oral | 49502-475NDA |
| - | Sertraline | powder | 65427-009BULK INGREDIENT |
| Soma | Carisoprodol | tablet, oral | 0037-2001NDA |
| Soma | Carisoprodol | tablet, oral | 0037-2250NDA |
| TOBI | Tobramycin | solution, oral, respiratory (inhalation) | 49502-345NDA |
| TOBI Podhaler | Tobramycin | capsule, oral, respiratory (inhalation) | 49502-401NDA |
| - | Tolterodine Tartrate | powder | 65427-020BULK INGREDIENT |
| URELLE | hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate | tablet, oral | 0037-6321UNAPPROVED DRUG OTHER |
| - | Varenicline | powder | 65427-010BULK INGREDIENT |
| Viagra | sildenafil citrate | tablet, film coated, oral | 58151-426NDA |
| Viagra | sildenafil citrate | tablet, film coated, oral | 58151-427NDA |
| Viagra | sildenafil citrate | tablet, film coated, oral | 58151-428NDA |
| XALATAN | Latanoprost | solution/ drops, ophthalmic | 58151-419NDA |
| Xanax | alprazolam | tablet, oral | 58151-452NDA |
| Xanax | alprazolam | tablet, oral | 58151-453NDA |
| Xanax | alprazolam | tablet, oral | 58151-454NDA |
| Xanax | alprazolam | tablet, oral | 58151-455NDA |
| Xanax XR | alprazolam | tablet, extended release, oral | 58151-505NDA |
| Xanax XR | alprazolam | tablet, extended release, oral | 58151-506NDA |
| YUPELRI | revefenacin | solution, respiratory (inhalation) | 49502-806NDA |
| Zoloft | sertraline hydrochloride | tablet, film coated, oral | 58151-574NDA |
| Zoloft | sertraline hydrochloride | tablet, film coated, oral | 58151-575NDA |
| Zoloft | sertraline hydrochloride | tablet, film coated, oral | 58151-576NDA |
| Zoloft | sertraline hydrochloride | solution, concentrate, oral | 58151-601NDA |
| - | celecoxib | powder | 65427-002BULK INGREDIENT |
| - | fluconazole | powder | 65427-025BULK INGREDIENT |
| - | nifedipine | powder | 65427-250BULK INGREDIENT |
| - | prazosin hydrochloride | tablet | 65427-300EXPORT ONLY |
| - | prazosin hydrochloride | tablet | 65427-301EXPORT ONLY |
| - | tolterodine | powder | 65427-022BULK INGREDIENT |
Neighbours
Registered in the same town
12- Biocon Biologics LimitedBengaluru, IND · 5 sites
- Micro Labs LimitedBengaluru, IND · 4 sites
- HARMAN FINOCHEM LIMITEDChhatrapati Sambhajinagar, IND · 4 sites
- SHILPA MEDICARE LIMITEDBengaluru, IND; Hyderabad, IND · 3 sites
- Syngene International LimitedBengaluru, IND · 3 sites
- AbbVie Inc.Barceloneta, PR · 2 sites
- CIPLA PHARMACEUTICALS LIMITEDBengaluru, IND · 2 sites
- Indoco Remedies LimitedChhatrapati Sambhajinagar, IND; Hyderabad, IND · 2 sites
- Apotex Inc.Bangalore, IND; Bengaluru, IND · 2 sites
- Matrix Pharmacorp Private LimitedHyderabad, IND · 2 sites
- GLAND PHARMA LIMITEDHyderabad, IND · 2 sites
- Sai Life Sciences LimitedHyderabad, IND · 2 sites
Enquiry
Common questions
- Is Viatris Inc. FDA approved?
- Viatris Inc. holds 18 FDA-registered establishments across 4 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Viatris Inc.'s drugs manufactured?
- At registered sites in Australia, India, Ireland, the United States. The FDA register lists Carole Park; Bangalore; Bengaluru; Chhatrapati Sambhajinagar; District - Dhar; Hosur, and 9 more. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Viatris Inc. make?
- 135 products are listed under Viatris Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.