Central alpha-2 Adrenergic Agonist
Where is Guanfacine made?
24 companies sell it under their own name and 18 repackagers rebottle it. Their labels name 16 factories in India, the United States, Taiwan, China, Italy and Spain.
India 6United States 5Taiwan 2China 1Italy 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. Intuniv1 mg, 1 mg / 2 mg, 2 mg, 3 mg, 4 mg · NDC 54092-513, 54092-520, 54092-515 +2 | Industriale Chimica SRLMakes the active ingredient | Saronno, Italy | Problems found, fixed voluntarilyOct 2025 |
| Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Greenville, NC, United States | No problems foundSep 2025 | |
| Pharmazell (India) Private LimitedMakes the active ingredient | Anakapalli, India | Problems found, fixed voluntarilyFeb 2025 | |
| Quimica Sintetica SaMakes the active ingredient | Alcala De Henares, Spain | Problems found, fixed voluntarilyApr 2025 | |
| Northstar Rx LLC.1 mg, 2 mg, 3 mg, 4 mg · NDC 72603-268, 16714-190, 72603-269 +3 | Chemo India Formulations Pvt LtdMakes it and tests it | Lalgadi Malakpet, India | No problems foundNov 2024 |
| Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 | |
| TWi Pharmaceuticals, Inc.1 mg, 2 mg · NDC 24979-198, 24979-199 | Bora Pharmaceutical Laboratories Inc.Makes it, tests it and packages it | Zhunan Township, Taiwan | Problems found, fixed voluntarilyJul 2025 |
| Bora Pharmaceutical Laboratories Inc. Zhongli PlantMakes it, tests it and packages it | Taoyuan City, Taiwan | Problems found, fixed voluntarilyFeb 2020 | |
| A2A Integrated Pharmaceuticals1 mg, 2 mg · NDC 73141-018, 73141-019 | i3 Pharmaceuticals, LLCMakes it and packages it | Warminster, PA, United States | Problems found, fixed voluntarilyMay 2026 |
| Advagen Pharma Ltd.1 mg, 2 mg, 3 mg, 4 mg · NDC 72888-224, 72888-123, 72888-225 +3 | Rubicon Research LimitedMakes it, tests it and labels it | Thane, India | No problems foundMar 2024 |
| Ajanta Pharma USA Inc.1 mg, 2 mg · NDC 27241-242, 27241-243 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Alembic Pharmaceuticals Inc.1 mg, 2 mg, 3 mg, 4 mg · NDC 62332-745, 62332-746, 62332-747 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited1 mg, 2 mg, 3 mg, 4 mg · NDC 46708-745, 46708-746, 46708-747 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals1 mg, 2 mg · NDC 65162-711, 53746-711, 65162-713 +1 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Aurobindo Pharma Limited1 mg, 2 mg · NDC 59651-840, 59651-841 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Epic Pharma, LLC1 mg, 2 mg · NDC 42806-048, 42806-296 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Promius Pharma, LLC. Tenex1 mg, 2 mg · NDC 67857-705, 67857-706 | Patheon Puerto Rico, Inc.Makes it | Location not on file | Not inspected on record |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals1 mg, 2 mg · NDC 24658-730, 24658-731 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Slate Run Pharmaceuticals, LLC.1 mg, 2 mg, 3 mg, 4 mg · NDC 70436-039, 70436-040, 70436-041 +1 | Yichang Humanwell Oral Solid Dosage PlantMakes it | Yichang, China | No problems foundJul 2023 |
| Upsher-Smith Laboratories, Inc.1 mg, 2 mg, 3 mg, 4 mg · NDC 24979-533, 24979-534, 24979-536 +1 | Bora Pharmaceutical Laboratories Inc. Zhongli PlantMakes it and tests it | Taoyuan City, Taiwan | Problems found, fixed voluntarilyFeb 2020 |
| Xiromed, LLC.1 mg, 2 mg · NDC 70700-301, 70700-302 | Chemo India Formulations Pvt LtdMakes it and tests it | Lalgadi Malakpet, India | No problems foundNov 2024 |
| i3 Pharmaceuticals, LLC1 mg, 2 mg · NDC 72319-018, 72319-019 | i3 Pharmaceuticals, LLCMakes it and packages it | Warminster, PA, United States | Problems found, fixed voluntarilyMay 2026 |
| Actavis Pharma, Inc.1 mg, 2 mg, 3 mg, 4 mg · NDC 0228-2850, 0591-0444, 0228-2851 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.1 mg, 2 mg, 3 mg, 4 mg · NDC 60505-3927, 60505-3928, 60505-3929 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.1 mg · NDC 42291-310 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.1 mg, 2 mg · NDC 62135-727, 62135-728 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Coupler LLC1 mg · NDC 67046-1433 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fosun Pharma USA Inc.1 mg, 2 mg, 3 mg, 4 mg · NDC 72266-255, 72266-256, 72266-257 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.1 mg, 2 mg, 3 mg, 4 mg · NDC 29300-458, 29300-460, 29300-459 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Guanfacine 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:
50090-6073,50090-5991,50090-6493,50090-7129+1 - American Health Packaging:
60687-710 - Atlantic Biologicals Corps.:
17856-0711 - AvKARE, Inc.:
42291-324,42291-325,42291-326,42291-327 - AvPAK:
50268-373,50268-374 - Bryant Ranch Prepack:
72162-1798,71335-2379,71335-3078,63629-8161+6 - Carilion Materials Management:
68151-0623 - Coupler LLC:
67046-1443,67046-1493,67046-1655 - Direct Rx:
72189-597,72189-469,72189-693 - Golden State Medical Supply, Inc.:
51407-952,60429-960,51407-953,60429-961+4 - Major Pharmaceuticals:
0904-7140 - NuCare Pharmaceuticals.Inc.:
68071-2719 - Physicians Total Care, Inc.:
54868-6447,54868-4876 - Precision Dose Inc.:
68094-065 - Proficient Rx LP:
63187-302,71205-944,71205-945,71205-946+1 - Remedyrepack Inc.:
70518-4539,70518-4333,70518-2771,70518-3809+5 - St. Mary's Medical Park Pharmacy:
60760-863 - TYA Pharmaceuticals:
64725-0513,64725-0711,64725-0515
Recalls
- Mar 31, 2021 · Class II · Apotex Corp.
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.