Site records / Telangana / FEI 3008768274

Cohance Lifesciences LimitedMedchal-Malkajgiri, Telangana

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

Inspections posted
4
Last inspection
Aug 2019 · VAI
Warning letters to this FEI
1
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. 20 Aug 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 3 citations posted
  2. 6 Feb 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · 4 citations posted
  3. 12 Jul 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  4. 11 Oct 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 30 Jan 2026Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

  1. 12 Aug 2025Form 483 · 17 pages Source

Other registered sites of COHANCE LIFESCIENCES LIMITED

Registration

FEI
3008768274
DUNS
677637710
Registered as
COHANCE LIFESCIENCES LIMITED
Registrant
COHANCE LIFESCIENCES LIMITED
Address
Plot No. A-19/C, A-23A, & A-23B, Road No. 18, IDA Nacharam, Uppal Mandal, Medchal-Malkajgiri, Telangana 500076, India (IND)
Operations
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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