India orders halt to Sun Pharma eye-drug production at Assam plant
Health · First reported 30 Oct, 12:55 · Updated 13:06
Indian regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products from its Assam facility after an inspection found quality-management lapses. The order remains in effect pending a satisfactory compliance report; the regulator is reviewing a report submitted by the company.
- Regulators ordered the halt on Aug. 20 after a joint federal-state inspection, following a July recall by Sun Pharma of about 11 eye-care brands.
- The order covers all ophthalmic products made at the Assam facility and continues until regulators receive a satisfactory compliance report; the company has submitted a report that is under review.
- Regulators sought information about a recall involving 332 batches. It is unclear whether all recalled products were contaminated or whether patients experienced adverse effects.
Summary written by Lux AI from 2 articles
Key facts
- Order date
- Aug. 20
- Facility
- Sun Pharma's Assam facility
- Recall
- About 11 eye-care brands; regulators sought information on 332 batches
- Next step
- Regulator reviewing the company's submitted compliance report
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