Laurus Labs 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
- Plot No. 19, 20 & 21, Western Sector APSEZ Gurajapalem Village, Rambilli Mandal, Anakapalli, Andhra Pradesh 531011, India (IND)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3011538548 · DUNS 650885309
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-02-10
- NAIDrug Quality Assurance2017-05-19
Drugs this plant is listed as making
19 distinct drugs across 49 products name this site in their FDA label.
- AtazanavirLaurus Labs Limited
- Atorvastatin CalciumLaurus Labs Limited
- DarunavirDr.Reddys Laboratories Inc
- Efavirenz, emtricitabine and tenofovir disoproxil fumarateLaurus Labs Limited
- Efavirenz, Lamivudine and Tenofovir Disoproxil FumarateLaurus Labs Limited
- Emtricitabine and Tenofovir Disoproxil FumarateLaurus Labs Limited
- emtricitabine, rilpivirine and tenofovir disoproxil fumarateLaurus Labs Limited
- GabapentinLaurus Labs Limited
- Hydroxychloroquine SulfateLaurus Labs Limited
- Lopinavir and RitonavirLaurus Labs Limited
- MacitentanLaurus Labs Limited
- Metformin HydrochlorideLaurus Labs Limited
- PirfenidoneLaurus Labs Limited
- PregabalinRising Pharma Holdings, Inc.
- Sacubitril and ValsartanLaurus Labs Limited
- UrsodiolLaurus Labs Limited
- ValsartanLaurus Labs 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.