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Boehringer Ingelheim (BI, Ingelheim, Germany) has received FDA approval for the contract manufacture of an unnamed biological drug in glass prefilled syringes.
Boehringer Ingelheim (BI, Ingelheim, Germany) has received FDA approval for the contract manufacture of an unnamed biological drug in glass prefilled syringes. BI has manufactured the drug in a lyophilized form since 1998.
This approval, which follows a similar European approval in July 2007, marks BI’s entry into the universe of prefilled syringes, and reflects a growing market preference for parenteral drugs to be offered in more user-friendly formats. BI will now compete with other contract manufacturers, such as Vetter Pharma-Fertigung GmbH & Co. KG (Vetter, Ravensburg, Germany), which already offers this type of filling.
Compared to drug administration by means of vials and syringes, prefilled syringes have several advantages, including convenience and safety for both patients and those administering medications. Prefilled syringes also significantly reduce the risk of administering the wrong drug or giving the wrong dose.
Vetter, meanwhile, has not been idle. The company recently received Japanese accreditation that will allow the company to partner as a contract manufacturer with Japanese pharmaceutical and biotech companies looking to sell drugs on the Japanese market.