Site records / Gujarat / FEI 3004086396
Zentiva Private LimitedAnkleshwar, Gujarat
FDA-registered drug establishment in Ankleshwar, Gujarat: api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 5
- Last inspection
- Feb 2025 · NAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- US border refusals, 2 years
- 1
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
5 FDA inspections of this FEI, by end date; 5 with a posted classification.
- 13 Feb 2025NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 7 Feb 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 1 Jul 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 19 May 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 4 Sep 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
No FDA compliance action recorded against this FEI or letter to its name.
Import alerts in force
No listing in force under this firm's name.
Registration
- FEI
- 3004086396
- DUNS
- 918593737
- Registered as
- Zentiva Private Limited
- Registrant
- Zentiva, k.s.
- Address
- Plot No 3501 to 3515, 6301 to 6313 & 16 Meter Road/c, GIDC Estate, ANKLESHWAR, Gujarat 393002, India (IND)
- Operations
- 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.