Prescription drug
Where is Ethinyl Estradiol and Norgestimate made?
11 companies sell it under their own name and 12 repackagers rebottle it. Their labels name 10 factories in India, the Netherlands, Germany, China, Italy and Spain.
India 4Netherlands 2Germany 1China 1Italy 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Xiromed, LLC.0.25 mg / 0.035 mg, 6 ingredients · NDC 70700-119, 70700-121, 70700-120 | Aspen Oss B.V.Makes the active ingredient | Oss, Netherlands | Problems found, fixed voluntarilyNov 2022 |
| Aspen Oss B.V.Makes the active ingredient | Oss, Netherlands | Problems found, fixed voluntarilyNov 2022 | |
| Industriale Chimica SRLMakes the active ingredient | Saronno, Italy | Problems found, fixed voluntarilyOct 2025 | |
| Laboratorios Leon Farma SAUMakes it, tests it, packages it and labels it | Villaquilambre, Spain | Problems found, fixed voluntarilyJul 2025 | |
| Afaxys Pharma LLC0.035 mg / 0.250 mg, 6 ingredients · NDC 50102-235, 50102-231, 50102-233 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Amneal Pharmaceuticals0.25 mg / 0.035 mg, 6 ingredients · NDC 69238-1551, 69238-1607 | Haupt Pharma Muenster GmbHMakes it, tests it and packages it | Muenster, Germany | Problems found, fixed voluntarilyNov 2024 |
| Aurobindo Pharma Limited0.035 mg / 0.250 mg, 6 ingredients · NDC 65862-776, 65862-778, 65862-777 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Glenmark Pharmaceuticals Inc., USA0.25 mg / 0.035 mg, 6 ingredients · NDC 68462-309, 68462-565 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Lupin Pharmaceuticals, Inc.0.25 mg / 0.035 mg, 6 ingredients · NDC 68180-840, 68180-838, 68180-837 | Lupin LimitedMakes it and packages it | Dhar, India | Problems found, fixed voluntarilySep 2024 |
| Mayne Pharma Inc.0.25 mg / 0.035 mg, 6 ingredients · NDC 51862-645, 51862-646 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Naari Pte. Limited0.25 mg / 0.035 mg, 6 ingredients · NDC 79929-008, 79929-009 | Naari Pharma Private LimitedMakes it, tests it and packages it | Rudrapur, India | Not inspected on record |
| Northstar Rx LLC.0.25 mg / 0.035 mg, 6 ingredients · NDC 16714-360, 16714-363 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| AvKARE, Inc.0.25 mg / 0.035 mg, 6 ingredients · NDC 42291-553, 42291-565, 42291-590 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.0.25 mg / 0.035 mg, 6 ingredients · NDC 0555-9016, 0093-2140, 0555-9018 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ethinyl Estradiol and Norgestimate in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-3962,50090-3733,50090-2429,50090-3413+4 - Bryant Ranch Prepack:
63629-2349,63629-2350,63629-2351 - Central Texas Community Health Centers:
76413-166,76413-121,76413-128 - MedVantx, Inc.:
66116-436 - PD-Rx Pharmaceuticals, Inc.:
72789-434,72789-435 - Physicians Total Care, Inc.:
54868-4730,54868-4093,54868-5028,54868-5826 - Preferred Pharmaceuticals, Inc..:
68788-7429,68788-7239,68788-7894,68788-6325 - Proficient Rx LP:
63187-911,82804-158,63187-754,63187-458+3 - RPK Pharmaceuticals, Inc.:
53002-1778,53002-1776,53002-1777,53002-1733+1 - Rebel Distributors Corp..:
21695-769,21695-770,21695-407 - RedPharm Drug. Inc.:
67296-0952,67296-2329 - Remedyrepack Inc.:
70518-0842
Recalls
- Sep 2, 2025 · Class II · AvKARE
Failed Content Uniformity Specifications - Mar 7, 2024 · Class II · Teva Pharmaceuticals USA, Inc
Failed Dissolution Specifications - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Jan 10, 2020 · Class III · Lupin Pharmaceuticals Inc.
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.