Drug factory · FDA FEI 3015380536
Natco Pharma Limited
Plot No.: 89 & 90, JNPC, SEZ, Visakha Pharmacity, Parawada Mandal, Anakapalli, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 3, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 64980-418 |
| Anastrozole | Makes it | Breckenridge Pharmaceutical, Inc., Natco Pharma Limited | 51991-620, 63850-0010 |
| Chloroquine | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 64980-177, 64980-178 |
| Desloratadine | Makes it | Natco Pharma USA LLC | 69339-194 |
| Everolimus | Makes it | Breckenridge Pharmaceutical, Inc., CivicaScript LLC, Natco Pharma Limited | 51991-821, 51991-822, 51991-823 +11 |
| Lanthanum Cation (3+) | Makes it | Lupin Pharmaceuticals, Inc. | 68180-819, 68180-820, 68180-821 |
| Lapatinib | Makes it | Lupin Pharmaceuticals, Inc. | 68180-801 |
| Letrozole | Makes it | Breckenridge Pharmaceutical, Inc., Natco Pharma Limited | 51991-759, 63850-0025 |
| Pomalidomide | Makes it | Breckenridge Pharmaceutical, Inc., Natco Pharma Limited | 51991-342, 51991-343, 51991-344 +5 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 3, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.