Indian API maker hosed by FDA over contamination potential 

The FDA is unhappy with India's CTX Life Sciences for not making sure the water it uses to make APIs is free of dangerous microbes. (Pixabay)

Sterile drugs are susceptible to microbial contamination and so the water used to make their ingredients need to be clean. An Indian API maker has been given that message loud and clear in a warning letter issued by the FDA. 

The water problem was discovered during an inspection of a CTX Life Sciences API manufacturing facility in Surat, Gujarat in February. The warning letter says that although the company knew its API was intended for a sterile injectable drug, the plant “failed to monitor and control the water used in the rinse steps for endotoxins.”

RELATED: FDA warning thrashes Indian drugmaker for filthy plant, data falsification

The FDA also had issues with the facility's handling of an out-of-spec test result for an impurity. CTX decided the reading must be the result of an equipment error and so invalidated the test result and moved on. The FDA says that was not nearly enough. The facility needed to thoroughly investigate to rule out other possible causes. 

Upcoming Webinar

Lifecycle Management Strategies Targeted For Patient Populations with Swallowing Disorders

Hear from industry experts as they discuss life cycle management strategies for patients with swallowing disorders and the overall impact on patient perception. The webinar will include several panel speakers representing different perspectives and case study examples. Save your spot and register today!

RELATED: Feds blame multistate B. cepacia outbreak on PharmaTech plant's water system

A water system that isn’t carefully monitored can lead to serious issues as federal authorities pointed out several years ago. In 2016, an outbreak of Burkholderia cepacia was tracked by the FDA and the CDC to the water system of Florida-based CMO PharmaTech. The company had produced 10 contaminated lots of constipation drug docusate sodium that resulted in 60 people in eight states becoming infected.

Suggested Articles

AbbVie has seen blossoming market share for immunology launches Rinvoq and Skyrizi—and it's eyeing Allergan's neurology biz for a boost, too.

While Novo's Rybelsus launch has slowed due to the pandemic, another version of the med, Ozempic posted strong sales.

Lonza is on deck to help manufacture AstraZeneca's COVID-fighting antibody duo at its Portsmouth, New Hampshire site.