Caplin Point Laboratories said it has received an Establishment Inspection Report (EIR) from the US FDA for a recently concluded inspection at the manufacturing plan run by its unit Caplin Steriles Limited. “This was the third successful US FDA audit at the plant since 2016,” the company said, referring to the June inspection. An EIR […]
Pharmaceuticals maker Caplin Point Laboratories said the US FDA has completed inspection of its Sterile Injectable manufacturing facility at Gummidipoondi in Chennai and issued two observations. The good manufacturing process inspection was done between June 6th and 14th. “The Company believes these to be of procedural in nature and the corrective and preventive actions for […]
Indian pharmaceutical manufacturer Caplin Point Laboratories said it received approval from Colombia’s drug regulatory body, The Colombia National Food and Drug Surveillance Institute (INVIMA), for its small volume sterile injectable division at Puducherry. The inspection was carried out on May 10. The Puducherry unit of Caplin Laboratories manufactures liquid injectables in vials, ampoules, lyophilized vials […]
Indian pharmaceutical manufacturer Caplin Point Laboratories said that its wholly-owned subsidiary Caplin Sterlites Ltd signed a licence and supply agreement with US healthcare firm Baxter International for sales of five generic injectable drugs. Under the agreement, Caplin will be supplying its products to Baxter for sales. “All these ANDAs [generic drugs] have been developed in-house, […]
Pharmaceutical manufacturer Caplin Point Laboratories Ltd said it received approval from the US Food and Drug Administration for sales of a generic equivalent of West-Ward Pharmaceuticals’ Robinul drug. Glycopyrrolate is a synthetic anticholinergic medication which works by blocking acetylcholine activity on smooth muscles and other tissues. Acetylcholine is a neurotransmitter, or a chemical that nerves […]
