Site records / Maharashtra / FEI 3006643860
Emcure Pharmaceuticals LimitedPune, Maharashtra
FDA-registered drug establishment in Pune, Maharashtra: analysis, api manufacture, label, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 1
- Last inspection
- Mar 2023 · NAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0 of 1 under the name
- US border refusals, 2 years
- 0
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
1 FDA inspection of this FEI, by end date; 1 with a posted classification.
- 31 Mar 2023NAI · No Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 3 Mar 2016Warning letter to Emcure Pharmaceuticals Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
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.
- 13 Jul 2015Import alert 66-40 · Published address cannot be tied to one site SourcePublished address: Plot No. P-2, I.T.B.T. Park, Phase - II, MIDC, Hinjawadi , Pune, Maharashtra INDIA
Other registered sites of Emcure Pharmaceuticals Limited
- Emcure Pharmaceuticals LimitedPune, Maharashtra
- Emcure Pharmaceuticals LimitedAhmedabad, Gujarat
- Emcure Pharmaceuticals LimitedSurendranagar, Gujarat
Registration
- FEI
- 3006643860
- DUNS
- 675467925
- Registered as
- EMCURE PHARMACEUTICALS LIMITED
- Registrant
- Emcure Pharmaceuticals Limited
- Address
- Plot Nos.: 12/1 & 2, F-II Block, M.I.D.C., Pimpri, Pune, Maharashtra 411018, India (IND)
- Operations
- ANALYSIS, API MANUFACTURE, LABEL, 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.