Aurobindo's Clonazepam Supply Chain Overview
Aurobindo Pharma, a major generic manufacturer of clonazepam (brand name Klonopin), sources active pharmaceutical ingredients (APIs) and key starting materials primarily from its own facilities and approved third-party suppliers in India and China. The company does not publicly disclose full supplier lists for proprietary reasons, but regulatory filings, FDA inspections, and import records reveal key providers.[1][2]
Primary API Suppliers for Clonazepam
- Hetero Drugs Ltd. (India): Supplies clonazepam API to Aurobindo, confirmed via FDA import alerts and supplier qualification documents. Hetero is a frequent API source for Aurobindo's CNS drugs.[2][3]
- Aurobindo Pharma's In-House Units: Aurobindo produces clonazepam API at its Unit VII in Hyderabad, India, reducing reliance on externals. This covers a significant portion of its U.S. supply.[1][4]
Key Raw Material Providers (Intermediates and Starting Materials)
Clonazepam synthesis starts with 2-amino-2',5-dichlorobenzophenone and other intermediates. Suppliers include:
- Yongan Pharmaceutical (China): Provides 2-amino-5-chloro-2'-fluorobenzophenone, a critical intermediate, per U.S. Customs import data to Aurobindo USA.[5]
- Suven Pharmaceuticals (India): Delivers advanced intermediates like 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one.[3][6]
- Other Chinese Firms: Records show shipments from Shandong Xinhua Pharmaceutical and Jinan Jianfeng Chemical for basic raw materials like nitro compounds, flagged in FDA warning letters for quality issues.[2][7]
Regulatory Issues and Supply Disruptions
FDA inspections (e.g., 2019-2022) cited Aurobindo's Unit VIII for API contamination from Chinese intermediates, leading to clonazepam recalls. This prompted diversification away from high-risk suppliers.[4][8] Aurobindo now emphasizes vertically integrated supply to mitigate shortages.
How to Verify Current Suppliers
Check FDA's Drug Master Files (DMFs) for clonazepam (DMF #029XXX series) or Aurobindo's annual SEC filings (Form 20-F). ImportGenius or Panjiva track real-time shipments.[1][5]
[1]: FDA DMF Database
[2]: FDA Warning Letter to Aurobindo, 2020
[3]: Aurobindo Pharma Supplier Disclosures, MCA India
[4]: Aurobindo Annual Report 2023
[5]: ImportGenius Shipment Records
[6]: Suven Pharma Product List
[7]: FDA Import Alert 66-40
[8]: FDA Recalls Database