Drug factory · FDA FEI 3009831799
Lupin Limited
Unit-1, Plot No. M-2 and M-2-A, Special Economic Zone, Phase II, MISC Zone Apparel Park, Pithampur, Dhar, India
Problems found, fixed voluntarily at FDA's last inspection, Sep 27, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2015: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Bosentan | Packages it |
Lupin Pharmaceuticals, Inc. |
68180-340 |
| Desogestrel and Ethinyl Estradiol | Makes it, makes the active ingredient and packages it |
Lupin Pharmaceuticals, Inc. |
68180-275, 68180-739 |
| Drospirenone and Ethinyl Estradiol | Makes it and packages it |
Lupin Pharmaceuticals, Inc. |
68180-868, 68180-886 |
| Drospirenone and Ethinyl Estradiol and Levomefolic Acid | Makes it, makes the active ingredient and packages it |
Lupin Pharmaceuticals, Inc. |
68180-894, 68180-904 |
| Ethinyl Estradiol and Levonorgestrel | Makes it, makes the active ingredient and packages it |
Lupin Pharmaceuticals, Inc. |
68180-843, 68180-844, 68180-846 +4 |
| Ethinyl Estradiol and Norethindrone | Makes it, makes the active ingredient and packages it |
Lupin Pharmaceuticals, Inc. |
68180-827, 68180-828, 68180-864 +7 |
| Ethinyl Estradiol and Norgestimate | Makes it and packages it |
Lupin Pharmaceuticals, Inc. |
68180-837, 68180-838, 68180-840 |
| Ethinyl Estradiol and Norgestrel | Makes it |
Lupin Pharmaceuticals, Inc. |
68180-895 |
| Hydrocortisone | Makes it and packages it |
Lupin Pharmaceuticals, Inc. |
68180-954 |
| Leflunomide | Makes it and packages it |
Lupin Pharmaceuticals, Inc. |
70748-129, 70748-130 |
| Levothyroxine | Makes it and packages it |
Lupin Pharmaceuticals, Inc. |
68180-965, 68180-966, 68180-967 +9 |
| Norethindrone | Makes it and packages it |
Lupin Pharmaceuticals, Inc. |
68180-876, 68180-877 |
| Varenicline | Makes it and packages it |
Lupin Pharmaceuticals, Inc. |
70748-125, 70748-127, 70748-128 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Sep 27, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 11, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 28, 2017 | No problems found | Drug Quality Assurance | — |
| Aug 5, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture; manufacture; pack.