Drug factory · FDA FEI 3005259207
Piramal Pharma Limited
Plot No. 67-70, Sector II, District Dhar, Pithampur, India
No problems found at FDA's last inspection, May 19, 2023.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2009: 5 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Amlodipine and Hydrochlorothiazide and Olmesartan | Makes it and tests it |
Slate Run Pharmaceuticals, LLC. |
70436-014, 70436-015, 70436-016 +2 |
| Baclofen | Makes it, tests it and packages it |
Northstar Rx LLC. |
16714-071, 16714-072 |
| Chlorpromazine | Makes it |
Zameer Pharmaceuticals LLC |
90096-131, 90096-132, 90096-133 +2 |
| Cinacalcet | Makes it |
Slate Run Pharmaceuticals, LLC. |
70436-007, 70436-008, 70436-009 |
| Citalopram | Makes it, tests it and packages it |
Torrent Pharma, Inc. |
13668-009, 13668-010, 13668-011 |
| Cyproheptadine | Makes it, tests it and packages it |
TruPharma LLC. |
52817-210 |
| Deferasirox | Makes it, tests it and packages it |
Xiromed, LLC. |
70700-269, 70700-270, 70700-271 |
| Droxidopa | Makes it |
Slate Run Pharmaceuticals, LLC. |
70436-140, 70436-141, 70436-142 |
| Hydroxyzine | Makes it, tests it and packages it |
Northstar Rx LLC. |
16714-081, 16714-082, 16714-083 |
| Labetalol | Makes it, tests it and packages it |
Biocon Pharma Inc. |
70377-060, 70377-061, 70377-062 +1 |
| Nortriptyline | Makes it, tests it and packages it |
Dr. Reddy's Laboratories Inc. |
75907-069, 75907-070, 75907-071 +1 |
| Oxybutynin | Makes it, tests it and packages it |
Rising Pharma Holdings, Inc. |
64980-679, 64980-734 |
| Primidone | Makes it |
Bausch Health US, LLC |
66490-690, 66490-691 |
| Rilpivirine | Makes it, tests it and packages it |
Somerset Therapeutics, LLC |
70069-848 |
| Tetrabenazine | Makes it |
Slate Run Pharmaceuticals, LLC. |
70436-101, 70436-102 |
| Trospium | Makes it |
Zameer Pharmaceuticals LLC |
90096-141 |
| Zolpidem | Makes it, tests it and packages it |
Torrent Pharma, Inc. |
13668-007, 13668-008 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| May 19, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 30, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 18, 2019 | No problems found | Drug Quality Assurance | — |
| Feb 21, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 3, 2015 | No problems found | Drug Quality Assurance | — |
| May 24, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 30, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.