Site records / Telangana / FEI 3003937580

Aurore Pharmaceuticals Private LimitedHyderabad, Telangana

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

Inspections posted
4
Last inspection
May 2024 · 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

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

  1. 31 May 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 25 May 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  3. 7 Feb 2014NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 29 Oct 2010VAI · 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
3003937580
DUNS
916568827
Registered as
AURORE PHARMACEUTICALS PRIVATE LIMITED
Registrant
Aurore Pharmaceuticals Private Limited
Address
(Unit-I), Plot Nos. 35,36,38 to 40, 49 to 51, Phase IV, IDA, Jeedimetla,, Hyderabad, Telangana 500055, 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.

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