FDA-Compliant Dosing Components for the Pharmaceutical Industry
In pharmaceutical packaging, the topical applicator roller ball is not a cosmetic accessory — it is a dosing device that must deliver the active ingredient to the patient accurately and consistently. A ball with inadequate tolerances can cause underdosing, overdosing, or cross-contamination through leakage.
Molding S.A.S. is an FDA compliant roll-on ball supplier manufacturing high-precision plastic applicator balls engineered for the most demanding pharmaceutical requirements. We use only virgin resins compliant with FDA 21 CFR — no plasticizers, no recycled material, and no additives that could migrate into the drug product.
Our ISO 9001 quality management system guarantees full traceability from virgin resin to finished product — an essential requirement for pharmaceutical supply chain audits and for sanitary registration filings with agencies such as INVIMA, COFEPRIS, DIGEMID or the FDA. For US and Latin American buyers, our plant in Cota, Cundinamarca — near Bogotá's El Dorado international airport — is a true nearshoring alternative: shorter lead times than Asian suppliers, preferential duty treatment under the US–Colombia FTA, and on-site plant audits without crossing an ocean.
We are the only manufacturer of hollow plastic roll-on balls in Colombia — featured in the trade magazine El Empaque — manufacturing since 2007, with a five-year R&D program behind every geometry and a metrology laboratory equipped with Japanese Mitutoyo instruments, the measurement standard expected in pharmaceutical supplier audits.
