Manufacture of Takeda’s injectable antibiotic Pansporin (cefotiam hydrochloride) was outsourced to Japanese CMO Taiyo Pharmaceutical.
A piece of glass is said to have been found in a vial of Pansporin on two occasions in May and June 2007, resulting in Takeda recalling all lots that could possibly have been contaminated.
Takeda has asserted that the presence of glass was attributable to Taiyo and has been pursuing the CMO for damages.
It claims to have tried to open discussions with Taiyo but the companies have been unable to reach a settlement. Consequently Takeda has filed a lawsuit with the Osaka district court in an attempt to recoup the losses that it believes Taiyo is responsible for.
In its filing Takeda asserts that “Taiyo failed to implement sufficient quality control procedures, such as those to prevent the commingling of glass in the production process”.
Takeda goes on to claim that Taiyo failed to prepare and maintain production records, which would have enabled the identification of the range of defective products in the event of their discovery.
Following the recall Takeda says it has moved production of all its injectable antibiotics to an in-house facility in Hikari, Japan. However, the company is still listed as a customer of Taiyo’s on the CMO’s website, alongside Pfizer Japan, Wyeth and Bayer.
Taiyo began its contract manufacturing operations in 1998 and now produces 215 products for 56 companies. Most of these items are injectables but the company also produces a considerable number of oral formulations.
Manufacturing takes place at the company’s facility in Takayama, Japan, which has a good manufacturing practice (GMP) compliant building dedicated to the manufacture of antibiotics. In 2007 the plant won the Facility of the Year award for equipment innovation.
Taiyo claims its facility is the “largest single manufacturing plant in Japan”, with an annual production capacity of 10.6bn tablets, 1,080 tons of granules, 90m injection ampoules, 40m vials and 82m syringes.
The CMO’s website outlines the quality assurance programmes that are in place at the Takayama facility, with the company saying “manufacturing very safe products” is one of its goals.
It also says its: “facilities are audited by objective third parties at such times as when we add a new product to our range or undergo any of the frequent GMP inspections that are conducted by major drug manufacturers both from Japan and overseas.”
Taiyo declined to comment when contacted by in-PharmaTechnologist.com as it has not yet received a written complaint from the court.