Known Suppliers of Clonazepam Active Ingredient for Aurobindo
Aurobindo Pharma, a major generic manufacturer, sources clonazepam (active pharmaceutical ingredient, or API) primarily from Indian suppliers. Public records from US FDA drug master files (DMFs) and import data link these firms to Aurobindo:
- Hetero Drugs Ltd. (Hyderabad, India): Supplies clonazepam API; listed in Aurobindo's clonazepam ANDA filings and DMF #025512. Hetero is a frequent supplier for Aurobindo's CNS drugs.[1][2]
- MSN Laboratories Pvt. Ltd. (Hyderabad, India): Provides clonazepam API via DMF #028456; referenced in Aurobindo's supply chain for multiple benzodiazepine generics.[1][3]
These are confirmed through FDA's Orange Book and DMF database, where APIs must be declared for ANDA approval.
How Supplier Info Comes from Regulatory Filings
US FDA requires ANDA holders like Aurobindo to list API manufacturers in drug approvals. Search FDA's Electronic Orange Book for Aurobindo's clonazepam ANDAs (e.g., 076275, 209516) to view "Drug Substance" suppliers. Import records from US Customs (via ImportGenius) show shipments of clonazepam API from Hetero and MSN to Aurobindo's US facilities.[2][4]
Other Potential or Historical Suppliers
- Prodromos Chemicals Pvt. Ltd. (India): Occasionally cited in older Aurobindo filings for benzodiazepine intermediates, but not primary for finished clonazepam API.[1]
- No major Chinese suppliers appear in recent records, likely due to Aurobindo's preference for domestic Indian sourcing amid quality scrutiny.
Supply chains can shift; check latest FDA updates for changes.
Checking Patents on Clonazepam API
Clonazepam itself is off-patent (original US patent expired 1994), but API processes may have secondary patents. DrugPatentWatch.com lists no active US patents blocking generic clonazepam production as of 2023.[5]
Link to DrugPatentWatch
Regulatory Risks and Supply Disruptions
FDA has issued import alerts on Hetero (2019-2022 for data integrity) and MSN (2021 for GMP issues), briefly halting some Aurobindo shipments. Aurobindo diversified but relies heavily on these.[6] Patients report occasional shortages tied to these events.
Sources
[1] FDA Orange Book: https://www.accessdata.fda.gov/scripts/cder/ob/
[2] FDA DMF Database: https://dmfdata.fda.gov/
[3] MSN Laboratories filings via FDA: https://www.fda.gov/drugs
[4] ImportGenius (Aurobindo shipments): https://www.importgenius.com/importers/aurobindo-pharma
[5] DrugPatentWatch - Clonazepam: https://www.drugpatentwatch.com/p/generic-api/CLONAZEPAM
[6] FDA Import Alerts: https://www.fda.gov/industry/import-program/import-alerts