Natco Pharma Limited
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- India
- Registered address
- Pharma Division, Kothur, Rangareddy, Telangana 509228, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004540906 · DUNS 918588174
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-06-19
- VAIDrug Quality Assurance2019-06-24
- VAIDrug Quality Assurance2019-06-06
- VAIDrug Quality Assurance2017-01-24
- VAIDrug Quality Assurance2014-05-23
- NAIDrug Quality Assurance2011-11-18
- VAIDrug Quality Assurance2009-02-12
Drugs this plant is listed as making
20 distinct drugs across 57 products name this site in their FDA label.
- AlprazolamNatco Pharma USA LLC
- AnastrozoleNatco Pharma Limited
- ArmodafinilNatco Pharma USA LLC
- Bisoprolol fumarateNatco Pharma USA LLC
- Doxorubicin HydrochlorideBluePoint Laboratories
- EverolimusNatco Pharma Limited
- Everolimus tabletsBreckenridge Pharmaceutical, Inc.
- Granisetron hydrochlorideNatco Pharma Limited
- Lanthanum CarbonateLupin Pharmaceuticals, Inc.
- lapatinibLupin Pharmaceuticals, Inc.
- LetrozoleNatco Pharma Limited
- NitroglycerinNatco Pharma USA LLC
- OndansetronNatco Pharma USA LLC
- Ondansetron TabletsNatco Pharma Limited
- PaclitaxelNatco Pharma USA LLC
- RisperidoneNatco Pharma USA LLC
- TeriflunomideNatco Pharma USA LLC
- TetrabenazineBionpharma Inc.
- Trihexyphenidyl HydrochlorideNatco Pharma Limited
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.