Softgel Healthcare Private 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
- Survey No. 20/1, Vandalur Kelambakkam Road, Pudupakkam, Chengalpattu, Tamilnadu 603103, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3006381009 · DUNS 676666501
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-02-14
- VAIDrug Quality Assurance2019-02-22
- VAIDrug Quality Assurance2016-04-29
- VAIDrug Quality Assurance2012-06-29
Drugs this plant is listed as making
4 distinct drugs across 5 products name this site in their FDA label.
- BenzonatateAscend Laboratories, LLC
- ErgocalciferolBionpharma Inc.
- Omega-3-acid ethyl estersLifestar Pharma LLC
- Valproic AcidBionpharma Inc.
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.