Site records / Madhya Pradesh / FEI 3009107538
Lupin LimitedPithampur, Madhya Pradesh
FDA-registered drug establishment in Pithampur, Madhya Pradesh: manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 3
- Last inspection
- Jul 2025 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- US border refusals, 2 years
- 1
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
3 FDA inspections of this FEI, by end date; 3 with a posted classification.
- 17 Jul 2025VAI · Voluntary Action IndicatedDrug Quality Assurance · 3 citations posted
- 18 Oct 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 27 Mar 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.
Form 483s released by FDA
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 LimitedDhar, Madhya Pradesh
- Lupin LimitedNagpur, Maharashtra
- Lupin LimitedNagpur, Maharashtra
- Lupin Manufacturing Solutions LimitedVadodara, Gujarat
- Lupin Manufacturing Solutions LimitedAnakapalli District, Andhra Pradesh
Registration
- FEI
- 3009107538
- DUNS
- 650595213
- Registered as
- LUPIN LIMITED
- Registrant
- LUPIN LIMITED
- Address
- Unit-3, Plot No. M-1 and M-3-A, Special Economic Zone, Phase - II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, Madhya Pradesh 454775, India (IND)
- Operations
- 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.