Site records / India / FEI 3005343793

Teva API India Private Ltd.Gajraula

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

Inspections posted
5
Last inspection
Jul 2023 · VAI
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

5 FDA inspections of this FEI, by end date; 5 with a posted classification.

  1. 18 Jul 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 9 Feb 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 1 May 2015NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 6 Jun 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  5. 20 Feb 2009NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 31 Jan 2011Warning letter to Teva Pharmaceutical Industries SourceCGMP for 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.

Registration

FEI
3005343793
DUNS
677604388
Registered as
Teva API India Private Ltd.
Registrant
Teva API India Private Ltd.
Address
Plot No. A-2, A-2/1, A-2/2 UPSIDC Industrial Area, Bijnor Road, Gajraula, Amroha (Uttar Prades 244235, 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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