Site records / Karnataka / FEI 3007078919
Apotex Research Private LimitedBangalore, Karnataka
FDA-registered drug establishment in Bangalore, Karnataka: analysis. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 3
- Last inspection
- May 2026 · NAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- US border refusals, 2 years
- 0
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
3 FDA inspections of this FEI, by end date; 3 with a posted classification.
- 8 May 2026NAI · No Action IndicatedBioresearch Monitoring · no citations posted
- 13 Dec 2024VAI · Voluntary Action IndicatedBioresearch Monitoring · no citations posted
- 7 Dec 2018NAI · No Action IndicatedBioresearch Monitoring · no citations posted
Warning letters and compliance actions
- 31 Oct 2025Warning letter to Apotex Inc. SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 30 Jan 2015Warning letter to Apotex Research Private Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 21 Feb 2013Warning letter to Apotex Inc SourceCGMP/Finished Pharmaceuticals/Adulterated/Misbranded · issued to the firm name; FDA does not tie it to this FEI
- 29 Mar 2010Warning letter to Apotex Inc. 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.
Other registered sites of Apotex Inc.
- Apotex Research Private LimitedBengaluru, Karnataka
Registration
- FEI
- 3007078919
- DUNS
- 650081412
- Registered as
- Apotex Research Private Limited
- Registrant
- Apotex Inc.
- Address
- Bioequivalence Center, Site No. 2, Bommasandra Industrial Area, Phase IV, Jigani Link Road, Bangalore, Karnataka 560099, India (IND)
- Operations
- ANALYSIS
- 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.