The U.S. Department of Defense recently issued a Request for Information (RFI) to conduct market research for manufacturing capabilities for a nerve agent pretreatment for use by military personnel.
The military currently procures a pretreatment for use prior to exposure to the chemical nerve agent soman, as part of Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP). Each tablet contains 30 mg of pyridostigmine bromide, as an orally active cholinesterase inhibitor, and is supplied in sealed blister or strip packaging within a protective sleeve.
The annual estimated quantity under the current contract is 36,000 blister packages containing 21 tablets each (or 756,000 tablets) per year. The current manufacturer of this product is Valeant Pharmaceuticals International.
System requirements include manufacturing capability to produce pyridostigmine bromide in the doses currently procured by the DoD, to include labeling, packaging and shipping configurations. The storage conditions and shelf life should be identical to. SNAPP.
The U.S. Army Office of The Surgeon General (OTSG) sponsors the SNAPP New Drug Application (NDA), approved in February 2003. It is anticipated that interested parties would become either a contract manufacturer under the OTSG NDA, or could potentially submit their own Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA).
This effort is managed by the Medical Countermeasure Systems – Chemical Defense Pharmaceuticals (MCS-CDP) Joint Product Management Office which is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, radiological and nuclear threats.
Further details are available under Solicitation Number: W911QY14SCDP3.