Site records / Maharashtra / FEI 3006809732

Zydus Lifesciences LimitedThane, Maharashtra

FDA-registered drug establishment in Thane, Maharashtra: analysis, api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
4
Last inspection
Feb 2025 · NAI
Warning letters to this FEI
0
Import alerts at this address
0
US border refusals, 2 years
0
The site dossier

This site, graded.
Every fact sourced.

  • A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
  • Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
  • Warning-letter violations, numbered and labelled
  • Import-alert history rebuilt from the archive, each listing checked against this address
  • Border refusals by product, and the company's other sites, each graded
  • A hash of every source read, so the PDF can be checked against the record

On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.

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Inspections

4 FDA inspections of this FEI, by end date; 4 with a posted classification.

  1. 14 Feb 2025NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  2. 10 Aug 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 24 Apr 2015NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 27 Jan 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 2 Jun 2026Warning letter to Zydus Lifesciences Limited SourceRequest for Records/CGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  2. 29 Aug 2024Warning letter to Zydus Lifesciences Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI

Import alerts in force

No listing in force under this firm's name.

Other registered sites of Zydus Lifesciences

Registration

FEI
3006809732
DUNS
643554130
Registered as
Zydus Lifesciences Limited
Registrant
Zydus Lifesciences Limited
Address
Plot No. N-15, MIDC, Additional Ambernath Anandnagar, Ambernath East, Thane, Maharashtra 421506, India (IND)
Operations
ANALYSIS, API MANUFACTURE
Registration expires
31 Dec 2026

Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.

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