Site records / Maharashtra / FEI 3008763768

Piramal Pharma LimitedNavi Mumbai, Maharashtra

FDA-registered drug establishment in Navi Mumbai, Maharashtra: api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
4
Last inspection
Feb 2025 · VAI
Warning letters to this FEI
0
Import alerts at this address
0 of 1 under the name
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. 17 Feb 2025VAI · Voluntary Action IndicatedDrug Quality Assurance, Monitoring of Marketed Animal Drugs, Feed, and Devices · no citations posted
  2. 8 Feb 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 13 Feb 2015NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 15 Mar 2011VAI · Voluntary Action IndicatedDrug Quality Assurance, Pre-Approval Eval. of Animal Drugs and Food Additives · 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. 27 Oct 2009Import alert 66-41 · Published address cannot be tied to one site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 1 Nirlon Complex , Western Express Highway , Mumbai, Maharashtra INDIA

Form 483s released by FDA

  1. 17 Feb 2025Form 483 · 10 pages Source

Other registered sites of Piramal Pharma

Registration

FEI
3008763768
DUNS
650515294
Registered as
Piramal Pharma Limited
Registrant
Piramal Pharma Limited
Address
C-43, MIDC, TTC Industrial Area, Turbhe, off Thane Belapur Road, Navi Mumbai, Maharashtra 400703, 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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