Caplin Point Labs Puducherry unit gets approval from Colombia drug regulator

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 and pre-filled syringes, amongst other dosage forms.

It currently caters to Latin American and African markets and manufactures various dosage forms such as tablets, capsules, liquid orals and topicals.

The site was found compliant to INVIMA’s norms of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), Caplin said.

Good manufacturing Practices are certain practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of sales and manufacture of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

Good Laboratory Practices are a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.

“Colombia is part of our expansion plans into the larger markets of Latin America. It also happens to be our first approval from Unit-1 site at Puducherry”, said C.C.Paarthipan, Chairman, Caplin Point Laboratories Ltd.

Established in 1992, INVIMA is a regulatory authority under Colombia’s Ministry of Health. It is in charge of inspecting and supervising the marketing and manufacturing of health products, identifying and evaluating the violation of health standards or procedures, and implementing best practices and providing medical approval for the import and export of products.

Headquartered in Chennai, Caplin Point Laboratories caters predominantly to the Latin American and African markets. The company has received over 2,800 product approvals.