Methylxanthine
Where is Theophylline made?
25 companies sell it under their own name and 13 repackagers rebottle it. Their labels name 17 factories in India, the United States and Germany.
India 8United States 8Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| ENDO USA, Inc.100 mg, 200 mg, 300 mg, 400 mg · NDC 52244-100, 52244-200, 52244-300 +1 | Neolpharma, Inc.Makes it, tests it, packages it and labels it | Caguas, PR, United States | Problems found, fixed voluntarilyMar 2026 |
| Siegfried PharmaChemikalien Minden GmbhMakes the active ingredient | Minden, Germany | Problems found, fixed voluntarilyApr 2023 | |
| Ajanta Pharma USA Inc.300 mg, 450 mg · NDC 27241-272, 27241-273 | Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 |
| Alembic Pharmaceuticals Inc.300 mg, 450 mg · NDC 62332-025, 62332-026 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited300 mg, 450 mg · NDC 46708-025, 46708-026 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals300 mg, 450 mg · NDC 60219-2045, 60219-2046 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Bionpharma Inc.300 mg · NDC 69452-267 | Recipharm Pharmaservices Private LimitedMakes it | Bengaluru, India | No problems foundMar 2024 |
| Brandywine Pharmaceuticals, LLC100 mg, 200 mg, 300 mg · NDC 71321-500, 71321-501, 71321-502 | Nostrum Laboratories, Inc.Makes it | Bryan, Ohio, United States | Problems found, fixed voluntarilyMar 2025 |
| Cadila Healthcare Limited300 mg, 450 mg · NDC 70771-1782, 70771-1783 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.300 mg, 450 mg · NDC 31722-077, 31722-078 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Glenmark Pharmaceuticals Inc., USA300 mg, 400 mg, 450 mg, 600 mg · NDC 68462-721, 68462-380, 68462-722 +1 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Harman Finochem Limited300 mg, 450 mg · NDC 82638-105, 82638-106 | Harman Finochem LimitedMakes it | Chhatrapati Sambhajinagar, India | No problems foundFeb 2024 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.300 mg, 450 mg · NDC 23155-741, 23155-742 | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it | East Brunswick, NJ, United States | No problems foundSep 2023 |
| Hospira, Inc.25 mg per 1 mL · NDC 0409-5921, 0409-5922 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Leading Pharma, LLC300 mg, 450 mg · NDC 69315-226, 69315-227 | Leading Pharma, LLCMakes it | Fairfield, NJ, United States | Problems found, fixed voluntarilyOct 2024 |
| Nostrum Laboratories, Inc.100 mg, 200 mg, 300 mg, 400 mg, 450 mg, 600 mg · NDC 29033-057, 29033-058, 29033-059 +3 | Nostrum Laboratories, Inc.Makes it, tests it, packages it and labels it | Bryan, Ohio, United States | Problems found, fixed voluntarilyMar 2025 |
| Nostrum Laboratories, Inc.80 mg per 15 mL · NDC 70408-644 | Nostrum Laboratories, Inc.Makes it, tests it and packages it | Bryan, Ohio, United States | Problems found, fixed voluntarilyMar 2025 |
| Pharmaceutical Associates, Inc.80 mg per 15 mL · NDC 0121-0820, 0121-4820 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it | Greenville, SC, United States | No problems foundAug 2025 |
| Viona Pharmaceuticals Inc.300 mg, 450 mg · NDC 72578-173, 72578-174 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Westminster Pharmaceuticals, LLC400 mg, 600 mg · NDC 69367-414, 69367-415 | MPP Pharma LLCMakes it, tests it, packages it and labels it | Kansas City, MO, United States | Serious problems, FDA actionApr 2026 |
| Chartwell Governmental & Specialty RX, LLC.80 mg per 15 mL · NDC 68999-556 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.80 mg per 15 mL, 300 mg · NDC 62135-457, 62135-556 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cranbury Pharmaceuticals, LLC80 mg per 15 mL · NDC 27808-033 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.80 mg per 15 mL · NDC 10135-604 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Strides Pharma Science Limited300 mg, 450 mg · NDC 64380-243, 64380-244 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.300 mg, 450 mg · NDC 0480-3310, 0480-3309 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Theophylline 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.
- Atlantic Biologicals Corps.:
17856-0644,17856-0038 - AvKARE, Inc.:
42291-922 - Bryant Ranch Prepack:
72162-2038,71335-2909 - Carilion Materials Management:
68151-1393,68151-0667,68151-4210,68151-0644 - Golden State Medical Supply, Inc.:
51407-318,51407-319 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1204,51662-1341 - Henry Schein, Inc.:
0404-9813,0404-9814 - Medical Purchasing Solutions, LLC.:
71872-7121,71872-7060,71872-7374 - PD-Rx Pharmaceuticals, Inc.:
72789-441,72789-442 - Physicians Total Care, Inc.:
54868-1461,54868-0028,54868-0029 - ProPharma Distribution:
84549-922 - Proficient Rx LP:
82804-941,82804-942 - State of Florida DOH Central Pharmacy:
53808-0315,53808-0316,53808-0982
Recalls
- Aug 8, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution c… - May 15, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
OOS results reported for the Dissolution (by UV) test. - Sep 27, 2022 · Class II · Pfizer Inc.
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Mar 6, 2020 · Class II · Nostrum Laboratories Inc
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.