Platinum-based Drug
Where is Carboplatin made?
13 companies sell it under their own name. Their labels name 8 factories in India, the United States and Australia.
India 6United States 1Australia 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.10 mg per 1 mL · NDC 16729-295 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 |
| Apotex Corp.10 mg per 1 mL · NDC 60505-6282 | Teyro Labs Private LimitedMakes it, tests it and packages it | Kanchipuram District, India | Problems found, fixed voluntarilyNov 2025 |
| AuroMedics Pharma LLC50 mg per 5 mL, 150 mg per 15 mL, 450 mg per 45 mL, 600 mg per 60 mL · NDC 55150-334, 55150-335, 55150-333 +1 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| BPI Labs, LLC10 mg per 1 mL · NDC 54288-165, 54288-166, 54288-167 +1 | Gland Pharma LimitedMakes it | Visakhapatnam, India | No problems foundJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.10 mg per 1 mL · NDC 47335-150, 47335-151, 47335-300 +1 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Fresenius Kabi, LLC10 mg per 1 mL · NDC 63323-172 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited10 mg per 1 mL · NDC 68083-190, 68083-191, 68083-192 +1 | Gland Pharma LimitedMakes it and tests it | Visakhapatnam, India | No problems foundJul 2023 |
| Hospira, Inc.10 mg per 1 mL · NDC 61703-339, 61703-360, 61703-150 +2 | Hospira Australia Pty LtdMakes it, tests it, packages it and labels it | Mulgrave, Australia | Problems found, fixed voluntarilySep 2022 |
| Natco Pharma USA LLC50 mg per 5 mL, 150 mg per 15 mL, 450 mg per 45 mL, 600 mg per 60 mL · NDC 69339-365, 69339-366, 69339-364 +1 | Teyro Labs Private LimitedMakes it | Kanchipuram District, India | Problems found, fixed voluntarilyNov 2025 |
| Sanja Pharmaceuticals Company50 mg per 5 mL, 150 mg per 5 mL, 450 mg per 5 mL · NDC 57277-106, 57277-107, 57277-105 | Zydus Lifesciences LimitedMakes it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2025 |
| Teyro Labs Private Limited50 mg per 5 mL, 150 mg per 15 mL, 450 mg per 45 mL, 600 mg per 60 mL · NDC 82511-004, 82511-005, 82511-003 +1 | Teyro Labs Private LimitedMakes it, tests it and packages it | Kanchipuram District, India | Problems found, fixed voluntarilyNov 2025 |
| Avyxa Pharma, LLC Kyxata20 mg per 2 mL, 80 mg per 8 mL, 500 mg per 50 mL · NDC 83831-140, 83831-142, 83831-141 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Parenteral Medicines, Inc.10 mg per 1 mL · NDC 0703-4244, 0703-4246, 0703-4248 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Nov 8, 2012 · Class I · Hospira Inc. · 2 recall notices
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. - Jul 2, 2012 · Class III · Hospira Inc.
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. - Jun 27, 2012 · Class II · Hospira Inc.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product t…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.