Site records / Telangana / FEI 3009876430

Shilpa Medicare LimitedMahabubnagar, Telangana

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

Inspections posted
6
Last inspection
Feb 2020 · OAI
Warning letters to this FEI
1
Import alerts at this address
1
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%.

PDF and data by email, usually within minutes, as of the day you buy. Card payment through Razorpay.

By buying you agree to the Terms and the refund policy: sales are final once delivered, except non-delivery.

Consultant plan · US$799 a month · five dossiers a month and watchlist alerts. Ask about the plan

Inspections

6 FDA inspections of this FEI, by end date; 6 with a posted classification.

  1. 25 Feb 2020OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  2. 6 Sep 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 2 citations posted
  3. 30 Nov 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  4. 28 Jul 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  5. 26 Jul 2016NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  6. 26 Aug 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 9 Oct 2020Warning Letter · CDER

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. 16 Feb 2021Import alert 66-40 · Published address is this site SourcePublished address: Plot No. S20 to S26, Pharmaceutical Formulations SEZ , TSIIC Green Industrial Park, Polepally (Village) , Jadcherla, Mahabubnagar District , Telangana INDIA

Form 483s released by FDA

  1. 30 Nov 2017Form 483 · 6 pages Source
  2. 25 Feb 2020Form 483 · 25 pages Source
  3. 21 Nov 2025Form 483 · 24 pages Source

Other registered sites of Shilpa Medicare

Registration

FEI
3009876430
DUNS
650644136
Registered as
SHILPA MEDICARE LIMITED
Registrant
SHILPA MEDICARE LIMITED
Address
S-20 to S-26, Pharmaceutical Formulations SEZ; TSIIC, Green Industrial Park, Polepally, Jadcherla, Mahabubnagar, Telangana 509301, India (IND)
Operations
ANALYSIS, MANUFACTURE, 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.

COUNTERFOIL / CONTACT

Contact us.

How can we help?

Stored privately by Counterfoil. Your email is used only to respond to your enquiry.