Site records / Telangana / FEI 3001319869
Granules India LimitedMedchal-Malkajgiri District, Telangana
FDA-registered drug establishment in Medchal-Malkajgiri District, Telangana: analysis, api manufacture, label, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 5
- Last inspection
- Jun 2023 · 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
5 FDA inspections of this FEI, by end date; 5 with a posted classification.
- 23 Jun 2023NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 23 Mar 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 18 Dec 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 8 May 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 6 Mar 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 26 Feb 2025Warning letter to Granules India Limited SourceCGMP/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 Granules India
- Granules Life Sciences Private LimitedShameerpet Medchal-Malkajgiri, Telangana
- Granules India LimitedSangareddy, Telangana
- Granules India LimitedMedchal-Malkajgiri District, Telangana
- Granules India LimitedAnakapalli, Andhra Pradesh
- Granules India LimitedAnakapalli, Andhra Pradesh
Registration
- FEI
- 3001319869
- DUNS
- 918457644
- Registered as
- Granules India Limited
- Registrant
- Granules India Ltd
- Address
- Plot No.15 A/1, Phase-III, IDA, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District, Telangana 500055, India (IND)
- Operations
- ANALYSIS, API MANUFACTURE, LABEL, PACK
- 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.