Site records / India / FEI 3005903939
Amneal Oncology Private LimitedMahaboobnagar
FDA-registered drug establishment in Mahaboobnagar: analysis, label, manufacture, pack, sterilize. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 2
- Last inspection
- Oct 2019 · VAI
- 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
2 FDA inspections of this FEI, by end date; 2 with a posted classification.
- 25 Oct 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 1 citation posted
- 15 Mar 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · 4 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.
Other registered sites of Amneal Pharmaceuticals of New York, LLC
- Amneal Pharmaceuticals Private LimitedAhmedabad, Gujarat
- Amneal Pharmaceuticals Private LimitedAhmedabad
- Amneal Pharmaceuticals Private LimitedAhmedabad
- Amneal Pharmaceuticals Private LimitedAhmedabad, Gujarat
Registration
- FEI
- 3005903939
- DUNS
- 860037948
- Registered as
- Amneal Oncology Private Limited
- Registrant
- Amneal Pharmaceuticals of New York, LLC
- Address
- Plot No. S-3, S-4, S-5A, TSIIC-SEZ Village-Polepally Mandal-Jadcherla MAHABOOBNAGAR, Mahaboobnagar, TG 509301, India (IND)
- Operations
- ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE
- 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.