Drug factory · FDA FEI 3007684569

Cadila Pharmaceuticals Limited

1389, Trasad Road, Dholka, Ahmedabad, India

No problems found at FDA's last inspection, Sep 26, 2025.

No Action Indicated: inspectors found no objectionable conditions.

7 drug inspections on record since 2012: 5 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acyclovir	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-004, 71209-005, 71209-006 +3
Atorvastatin	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited	71209-090, 71209-091, 71209-092 +1
Bupropion	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-052, 71209-053, 72241-020 +1
Celecoxib	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-054, 71209-055, 71209-056 +5
Donepezil	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited	71209-019, 71209-020
Erythromycin	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Kanchan Healthcare Inc, Modavar Pharmaceuticals LLC, Orange Pharmaceuticals USA LLC	71209-100, 71209-101, 71209-102 +7
Ethambutol	Makes it	Kanchan Healthcare Inc, Marlex Pharmaceuticals, Inc.	85742-005, 85742-006, 10135-796 +1
Folic Acid	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-007, 72241-050
Gemfibrozil	Makes it	Cadila Pharmaceuticals Limited	71209-008
Glyburide	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-009, 71209-010, 71209-011 +3
Hydralazine	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-016, 71209-017, 71209-018 +3
Labetalol	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited	71209-083, 71209-084, 71209-085
Metronidazole	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Kanchan Healthcare Inc	71209-062, 71209-063, 85742-024 +1
Nateglinide	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-030, 71209-031, 72241-002 +1
Nebivolol	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-058, 71209-059, 71209-060 +5
Ofloxacin	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-097, 71209-098, 71209-099 +3
Olanzapine	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-073, 71209-074, 71209-075 +9
Olmesartan	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-079, 71209-080, 71209-081 +3
Paroxetine	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-094, 71209-095, 71209-096 +3
Pregabalin	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited	71209-032, 71209-033, 71209-034 +5
Raloxifene	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-082, 72241-010
Rivastigmine	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-012, 71209-013, 71209-014 +5
Rosuvastatin	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited	71209-043, 71209-044, 71209-045 +1
Sildenafil	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-106, 71209-107, 71209-108 +3
Telmisartan	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-049, 71209-050, 71209-051 +3
Tizanidine	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Kanchan Healthcare Inc, Modavar Pharmaceuticals LLC	71209-064, 71209-065, 71209-066 +6
Venlafaxine	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited, Modavar Pharmaceuticals LLC	71209-025, 71209-026, 71209-027 +8
Verapamil	Makes it, tests it, packages it and labels it	Cadila Pharmaceuticals Limited	71209-047, 71209-048, 71209-104

FDA inspection history

Ended	Result	Program	Problems noted
Sep 26, 2025	No problems found	Bioresearch Monitoring	—
Apr 7, 2023	No problems found	Drug Quality Assurance	—
Jun 17, 2022	No problems found	Bioresearch Monitoring	—
Feb 14, 2020	No problems found	Drug Quality Assurance	—
May 3, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	1
May 15, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 21, 2012	No problems found	Drug Quality Assurance	—

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 3, 2018 inspection

Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.

Registered with FDA for: analysis; label; manufacture; pack.