Kalbe To Re-Examine All Products Injections To Eliminate Any Potential Risks
Press Release No. 004/KFCP-DIR/PR/III/15
Jakarta, 25 March 2015 - PT Kalbe Farma Tbk (Kalbe) today said that it will re-examine all its injection products manufactured in Kalbe Cikarang factory line 6, those that are still at the distributors as well as those still circulating in the market.
In connection with results of the examination conducted by the National Agency of Drug and Food Control (NA-DFC) on 3-6 March 2015, NA-DFC noticed provision discrepancies of Good Manufacturing Practices (GMP) and subsequently requested that Kalbe make efforts to eliminate all potential risks in all injectable products manufactured in line 6 at Kalbe Cikarang factory that have already been circulated.
"We accept the decision of NA-DFC and will make improvements as suggested by NA-DFC ," said Irawati Setiady, President Director of Kalbe. "As a responsible pharmaceutical company, Kalbe is aware of the potential risks and will recall and re-examine all our injection products to ensure there is no potential risk. However, this recall and re-examination are carried out not because of customer complaints. "
"These products are actually not sold freely in the market and can only be obtained with prescriptions in certain hospitals, clinics and pharmacies," said Vidjongtius, Kalbe’s Director and Company Secretary.
Meanwhile, Kalbe has ceased manufacturing all its drug injection products in line 6 since 17 February 2015 and returned the Buvanest Spinal distribution license to NA-DFC.
"Kalbe has conducted a thorough examination along with NA-DFC on injection products and production processes," continued Vidjongtius. "From this thorough examination, it is known that Kalbe is required to conduct a Corrective Action and Preventive Action (CAPA) although so far no evidence of deviation has been found in all Buvanest Spinal products that have been withdrawn."
"As a company engaged in the field of health, Kalbe strives to work in accordance with its core values in providing quality products and health services to serve all the people of Indonesia, as reflected in our mission: Improving Health for a Better Life," closed Irawati Setiady.
Kalbe at a Glance
PT Kalbe Farma Tbk. (“Kalbe”) was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions managing a broad and strong portfolio of brands; prescription pharmaceuticals division (Cefspan, Brainact, Broadced, etc), consumer health division comprising over-the-counter drugs (Promag, Mixagrip, Komix, Woods, Fatigon, etc) as well as ready-to-drink and energy drink products (Hydro Coco, Extra Joss, Nitros), nutritionals division (ChilKid, Prenagen, Diabetasol, etc), and distribution division. Kalbe currently has more than 20 subsidiaries and 10 production facilities with international standards, supported by more than 17,000 employees and 6,000 sales and marketing personnel, spread in 69 branches across Indonesia. Since 1991, Kalbe’s shares have been listed on the Indonesia Stock Exchange (IDX: KLBF).