Site records / Telangana / FEI 3004987008

Alkaloids Private LimitedMedchal-Malkajgiri District, Telangana

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

Inspections posted
3
Last inspection
Sep 2024 · VAI
Warning letters to this FEI
0
Import alerts at this address
2
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

3 FDA inspections of this FEI, by end date; 3 with a posted classification.

  1. 20 Sep 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 17 May 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 17 Feb 2011VAI · 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

Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.

  1. 22 Jan 2010Import alert 66-66 · Published address is this site SourcePublished address: 25/3 Gundla Pochampally , Medchal-Malkajgiri District , Rangareddy, Telangana INDIA
  2. 22 Jan 2010Import alert 66-66 · Published address is this site SourcePublished address: 834(P) Medchal Shamirpet Road, Medchal Mandal , Medchal-Malkajgiri District , Medchal, Telangana INDIA

Other registered sites of ALKALOIDS BIOACTIVES PRIVATE LIMITED

Registration

FEI
3004987008
DUNS
650488401
Registered as
Alkaloids Private Limited
Registrant
ALKALOIDS BIOACTIVES PRIVATE LIMITED
Address
25/3 Gundlapochampally,, Medchal-Malkajgiri District, Telangana 500100, 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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