Site records / Telangana / FEI 3004443761

Alkaloids Bioactives Private LimitedMedchal-Malkajgiri, Telangana

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

Inspections posted
3
Last inspection
Feb 2024 · NAI
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

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

  1. 23 Feb 2024NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  2. 9 Jun 2016NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  3. 25 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

No listing in force under this firm's name.

Other registered sites of ALKALOIDS BIOACTIVES PRIVATE LIMITED

Registration

FEI
3004443761
DUNS
677600521
Registered as
ALKALOIDS BIOACTIVES PRIVATE LIMITED
Registrant
ALKALOIDS BIOACTIVES PRIVATE LIMITED
Address
834 (P) Medchal Shamirpet Road, Medchal Mandal,, Medchal-Malkajgiri, Telangana 501401, 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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