Register entry
- Registered sites
- 5
- Active NDC listings
- 108
- Labeller names
- 3
- Live patents
- 0
- Countries
- 2
- Base
- India
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture2Labelling3Finished drug manufacture2Packaging2Repackaging1
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| NATCO PHARMA LIMITED | Plot No.: 89 & 90, JNPC, SEZ, Visakha Pharmacity, Parawada Mandal, Anakapalli, Andhra Pradesh 531019, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3015380536675484209 |
| NATCO PHARMA LIMITED | Chemical Division, Chennai, No 74/7B, Vaikkadu TPP Salai, Manali, Chennai, Tamil Nadu 600103, India (IND) | Active ingredient (API) manufacture | 3009870595677603796 |
| NATCO PHARMA LIMITED | Chemical Division, Mekaguda Village, Nandigama Mandal, Rangareddy, Telangana 509223, India (IND) | Active ingredient (API) manufacture | 3004065860862497174 |
| NATCO PHARMA LIMITED | Pharma Division, Kothur, Rangareddy, Telangana 509228, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004540906918588174 |
| Natco Pharma USA LLCRegistrant: NATCO PHARMA LIMITED | 300 Interpace Pkwy Bldg C Ste 100, Parsippany, New Jersey (NJ) 07054, United States (USA) | Labelling, Repackaging | 3012899356079590418 |
Catalogue
Drug listings by form and route
108108 active NDC listings: 59 human prescription drug, 45 bulk ingredient, 4 human otc drug. By marketing category: ANDA 57, BULK INGREDIENT 45, OTC MONOGRAPH DRUG 4, NDA AUTHORIZED GENERIC 2.
| Dosage form | NDCs |
|---|---|
| powder | 43 |
| tablet | 29 |
| injection, solution | 9 |
| tablet, orally disintegrating | 6 |
| tablet, film coated | 5 |
| capsule | 4 |
| solution | 4 |
| capsule, gelatin coated | 2 |
| injection | 2 |
| syrup | 2 |
| liquid | 1 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 51 |
| intravenous | 9 |
| sublingual | 3 |
| intramuscular | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| natco pharma limited | 53 |
| natco pharma usa llc | 44 |
| natco pharma limited | 11 |
Catalogue
Marketed products
108| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | ANASTROZOLE | powder | 63850-6527BULK INGREDIENT |
| - | APIXABAN | powder | 63850-8085BULK INGREDIENT |
| - | Acalabrutinib Dihydrate | powder | 63850-8113BULK INGREDIENT |
| Alprazolam | Alprazolam | tablet, oral | 69339-199ANDA |
| Alprazolam | Alprazolam | tablet, oral | 69339-200ANDA |
| Alprazolam | Alprazolam | tablet, oral | 69339-201ANDA |
| Alprazolam | Alprazolam | tablet, oral | 69339-202ANDA |
| Anastrozole | Anastrozole | tablet, oral | 63850-0010ANDA |
| Armodafinil | Armodafinil | tablet, oral | 69339-177ANDA |
| Armodafinil | Armodafinil | tablet, oral | 69339-178ANDA |
| Armodafinil | Armodafinil | tablet, oral | 69339-179ANDA |
| Armodafinil | Armodafinil | tablet, oral | 69339-180ANDA |
| Bisoprolol fumarate | Bisoprolol fumarate | tablet, oral | 69339-236ANDA |
| Bisoprolol fumarate | Bisoprolol fumarate | tablet, oral | 69339-237ANDA |
| - | Bortezomib | powder | 70225-1102BULK INGREDIENT |
| CARBOPLATIN | CARBOPLATIN | injection, solution, intravenous | 69339-364ANDA |
| CARBOPLATIN | CARBOPLATIN | injection, solution, intravenous | 69339-365ANDA |
| CARBOPLATIN | CARBOPLATIN | injection, solution, intravenous | 69339-366ANDA |
| CARBOPLATIN | CARBOPLATIN | injection, solution, intravenous | 69339-367ANDA |
| - | Carmustine | powder | 70225-1107BULK INGREDIENT |
| - | Chloroquine Phosphate | powder | 63850-8080BULK INGREDIENT |
| - | Cidofovir Dihydrate | powder | 70225-1111BULK INGREDIENT |
| DASH Chlorhexidine Gluconate 0.12% Oral Rinse | Chlorhexidine Gluconate 0.12% Oral Rinse | liquid, oral | 69339-138ANDA |
| Desloratadine | Desloratadine | tablet, film coated, oral | 69339-194ANDA |
| Diazepam | DIAZEPAM | injection, solution, intramuscular, intravenous | 69339-136ANDA |
| Diazepam | DIAZEPAM | injection, solution, intramuscular, intravenous | 69339-137ANDA |
| Diphenhydramine HCl Oral Solution | diphenhydramine hydrochloride | solution, oral | 69339-151OTC MONOGRAPH DRUG |
| Diphenhydramine HCl Oral Solution | diphenhydramine hydrochloride | solution, oral | 69339-152OTC MONOGRAPH DRUG |
| - | EVEROLIMUS | powder | 70225-1103BULK INGREDIENT |
| - | Erdafitinib | powder | 70225-1113BULK INGREDIENT |
| - | Erlotinib | powder | 63850-7566BULK INGREDIENT |
| Everolimus | Everolimus | tablet, oral | 63850-0058ANDA |
| Everolimus | Everolimus | tablet, oral | 63850-0059ANDA |
| Everolimus | Everolimus | tablet, oral | 63850-0060ANDA |
| Everolimus | Everolimus | tablet, oral | 63850-0061ANDA |
| Everolimus | Everolimus | tablet, oral | 63850-0062ANDA |
| Everolimus | Everolimus | tablet, oral | 63850-0063ANDA |
| Everolimus | Everolimus | tablet, oral | 63850-0064ANDA |
| Everolimus | Everolimus | tablet, oral | 63850-0107ANDA |
| - | GEFITINIB | powder | 63850-8070BULK INGREDIENT |
| Gefitinib | Gefitinib | tablet, film coated, oral | 69339-168ANDA |
| - | Glatiramer Acetate | injection | 63850-4035BULK INGREDIENT |
| - | Granisetron | powder | 63850-7308BULK INGREDIENT |
| Granisetron hydrochloride | Granisetron hydrochloride | tablet, film coated, oral | 63850-0005ANDA |
| Guaifenesin Syrup and Dextromethorphan | Guaifenesin Syrup and Dextromethorphan | syrup, oral | 69339-149OTC MONOGRAPH DRUG |
| Guaifenesin Syrup and Dextromethorphan | Guaifenesin Syrup and Dextromethorphan | syrup, oral | 69339-150OTC MONOGRAPH DRUG |
| - | IBRUTINIB | powder | 63850-8089BULK INGREDIENT |
| - | Ibandronate Sodium | powder | 63850-4355BULK INGREDIENT |
| - | Idelalisib | powder | 63850-8098BULK INGREDIENT |
| - | Imatinib | powder | 63850-4826BULK INGREDIENT |
| - | Imatinib | powder | 63850-8126BULK INGREDIENT |
| Itraconazole Oral | Itraconazole | solution, oral | 69339-159ANDA |
| - | LANSOPRAZOLE | powder | 63850-3309BULK INGREDIENT |
| - | LANTHANUM CARBONATE DIHYDRATE | powder | 63850-2761BULK INGREDIENT |
| LUBIPROSTONE | LUBIPROSTONE | capsule, gelatin coated, oral | 69339-162NDA AUTHORIZED GENERIC |
| LUBIPROSTONE | LUBIPROSTONE | capsule, gelatin coated, oral | 69339-163NDA AUTHORIZED GENERIC |
| - | Lapatinib Ditosylate Anhydrous | powder | 63850-7421BULK INGREDIENT |
| Letrozole | Letrozole | tablet, oral | 63850-0025ANDA |
| - | Letrozole | powder | 63850-7701BULK INGREDIENT |
| - | Letrozole | powder | 63850-7723BULK INGREDIENT |
| Levetiracetam | Levetiracetam | solution, oral | 69339-157ANDA |
| Megestrol Acetate | Megestrol Acetate | suspension, oral | 69339-160ANDA |
| NITROGLYCERIN | NITROGLYCERIN | tablet, sublingual | 69339-173ANDA |
| NITROGLYCERIN | NITROGLYCERIN | tablet, sublingual | 69339-174ANDA |
| NITROGLYCERIN | NITROGLYCERIN | tablet, sublingual | 69339-175ANDA |
| - | OMEPRAZOLE | powder | 63850-3153BULK INGREDIENT |
| Ondansetron | Ondansetron Tablets | tablet, film coated, oral | 63850-0003ANDA |
| Ondansetron | Ondansetron Tablets | tablet, film coated, oral | 63850-0004ANDA |
| - | Ondansetron | powder | 63850-2706BULK INGREDIENT |
| Ondansetron | Ondansetron | tablet, oral | 69339-171ANDA |
| Ondansetron | Ondansetron | tablet, oral | 69339-172ANDA |
| - | PANTOPRAZOLE SODIUM | powder | 63850-3210BULK INGREDIENT |
| Paclitaxel | Paclitaxel | injection, solution, intravenous | 69339-227ANDA |
| Paclitaxel | Paclitaxel | injection, solution, intravenous | 69339-228ANDA |
| Paclitaxel | Paclitaxel | injection, solution, intravenous | 69339-229ANDA |
| Pomalidomide | Pomalidomide | capsule, oral | 63850-0131ANDA |
| Pomalidomide | Pomalidomide | capsule, oral | 63850-0132ANDA |
| Pomalidomide | Pomalidomide | capsule, oral | 63850-0133ANDA |
| Pomalidomide | Pomalidomide | capsule, oral | 63850-0134ANDA |
| - | Pomalidomide | powder | 70225-1106BULK INGREDIENT |
| Risperidone | Risperidone | tablet, orally disintegrating, oral | 69339-181ANDA |
| Risperidone | Risperidone | tablet, orally disintegrating, oral | 69339-182ANDA |
| Risperidone | Risperidone | tablet, orally disintegrating, oral | 69339-183ANDA |
| Risperidone | Risperidone | tablet, orally disintegrating, oral | 69339-184ANDA |
| Risperidone | Risperidone | tablet, orally disintegrating, oral | 69339-185ANDA |
| Risperidone | Risperidone | tablet, orally disintegrating, oral | 69339-186ANDA |
| - | Rizatriptan | powder | 63850-7119BULK INGREDIENT |
| - | Rizatriptan | powder | 63850-7138BULK INGREDIENT |
| - | Ruxolitinib Phosphate | powder | 63850-8125BULK INGREDIENT |
| - | Salmeterol | powder | 63850-3912BULK INGREDIENT |
| - | Sorafenib | powder | 63850-8051BULK INGREDIENT |
| - | Sugammadex Sodium | powder | 63850-8099BULK INGREDIENT |
| - | TRABECTEDIN | injection | 70225-1110BULK INGREDIENT |
| - | TRIHEXYPHENIDYL | powder | 63850-6535BULK INGREDIENT |
| - | Teriflunomide | powder | 63850-8081BULK INGREDIENT |
| Teriflunomide | Teriflunomide | tablet, oral | 69339-169ANDA |
| Teriflunomide | Teriflunomide | tablet, oral | 69339-170ANDA |
| - | Thiotepa | powder | 70225-1104BULK INGREDIENT |
| - | Tipiracil Hydrochloride | powder | 70225-1109BULK INGREDIENT |
| - | Trifluridine | powder | 70225-1108BULK INGREDIENT |
| Trihexyphenidyl Hydrochloride | Trihexyphenidyl Hydrochloride | tablet, oral | 63850-0021ANDA |
| Trihexyphenidyl Hydrochloride | Trihexyphenidyl Hydrochloride | tablet, oral | 63850-0022ANDA |
| - | Venetoclax | powder | 63850-8103BULK INGREDIENT |
| - | ZOLMITRIPTAN | powder | 63850-4322BULK INGREDIENT |
| - | Zoledronic Acid | powder | 63850-7104BULK INGREDIENT |
| - | bendamustine hydrochloride | powder | 70225-1101BULK INGREDIENT |
| - | citalopram | powder | 63850-3616BULK INGREDIENT |
| - | nILOTINIB HYDROCHLORIDE MONOHYDRATE | powder | 63850-8106BULK INGREDIENT |
Neighbours
Registered in the same town
12- LAURUS LABS LIMITEDAnakapalli, IND · 4 sites
- Biocon Biologics LimitedAnakapalli, IND · 2 sites
- Granules Pharmaceuticals Inc.Anakapalli, IND · 2 sites
- Par Health USA, LLCChennai, IND · 2 sites
- Pharmazell (India) Private LimitedAnakapalli, IND; Chennai, IND · 2 sites
- LAURUS SYNTHESIS PRIVATE LIMITEDAnakapalli, IND · 2 sites
- Ferring Pharmaceuticals Inc.Parsippany, NJ
- Viyash Scientific LimitedAnakapalli, IND
- MSN Laboratories Private Limited,Rangareddy, IND
- Apitoria Pharma Private LimitedAnakapalli, IND
- Hospira, Inc.Anakapalli, IND
- Cohance Lifesciences LimitedRangareddy, IND
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- Torrent Pharma, Inc.5 sites · 184 NDC
- Micro Labs Limited5 sites · 141 NDC
- Matrix Pharmacorp Private Limited5 sites · 122 NDC
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Enquiry
Common questions
- Is NATCO PHARMA LIMITED FDA approved?
- NATCO PHARMA LIMITED holds 5 FDA-registered establishments across 2 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 NATCO PHARMA LIMITED's drugs manufactured?
- At registered sites in India, the United States. The FDA register lists Anakapalli; Chennai; Rangareddy; Parsippany, NJ. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, repackaging.
- What drugs does NATCO PHARMA LIMITED make?
- 108 products are listed under NATCO PHARMA LIMITED in the openFDA NDC Directory, most often as powder; tablet; injection, solution. 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.