Site records / Madhya Pradesh / FEI 3009831799
Lupin LimitedDhar, Madhya Pradesh
FDA-registered drug establishment in Dhar, Madhya Pradesh: api manufacture, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 4
- Last inspection
- Sep 2024 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- 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
4 FDA inspections of this FEI, by end date; 4 with a posted classification.
- 27 Sep 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 11 Feb 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 28 Jul 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 5 Aug 2015NAI · No Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 27 Sep 2022Warning letter to Lupin Limited SourceCGMP/Active Pharmaceutical Ingredient (API)/Adulterated · issued to the firm name; FDA does not tie it to this FEI
Import alerts in force
No listing in force under this firm's name.
Other registered sites of Lupin
- Lupin LimitedMandideep, Madhya Pradesh
- Lupin LimitedTarapur, Maharashtra
- Lupin LimitedSalcette, Goa
- Lupin LimitedChhatrapati Sambhajinagar, Maharashtra
- Lupin LimitedPithampur, Madhya Pradesh
- Lupin LimitedMandideep, Madhya Pradesh
- Lupin LimitedPithampur, Madhya Pradesh
- Lupin LimitedNagpur, Maharashtra
- Lupin LimitedNagpur, Maharashtra
- Lupin Manufacturing Solutions LimitedVadodara, Gujarat
- Lupin Manufacturing Solutions LimitedAnakapalli District, Andhra Pradesh
Registration
- FEI
- 3009831799
- DUNS
- 650582310
- Registered as
- LUPIN LIMITED
- Registrant
- LUPIN LIMITED
- Address
- Unit-1, Plot No. M-2 and M-2-A, Special Economic Zone, Phase II, MISC Zone Apparel Park, Pithampur, Dhar, Madhya Pradesh 454775, India (IND)
- Operations
- API MANUFACTURE, 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.