FDA seeks information on global API market
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has issued a request for quote (RFQ) to help the agency better understand the global active pharmaceutical ingredient (API) market.The RPF recognizes the “critical importance that API manufacturers have in producing safe and effective drugs.”
FDA said information gleaned from this RFQ “can assist CDER in programs that rely on manufacturing information for the purposes of compliance, surveillance, enforcement, drug shortages and user fee collections.”
An FDA spokesperson told Focus that the agency currently “only collects data on API manufacturers regulated by FDA,” and that “this request allows FDA to improve and validate our understanding of worldwide API manufacturing.”
Under the contract, the vendor will “procure API Manufacturing facility and product data that will be used in program analysis” and “the contractor shall be responsible for delivering a file containing as complete a list of all API manufacturers as possible.”
There have been calls by the National Academies of Science, Engineering and Medicine (NASEM) for FDA to publicly disclose the location of all manufacturing facilities that supply ingredients for pharmaceuticals and medical devices approved in the US both to ensure the resiliency in the medical supply chain and reduce drug shortages. (RELATED: NASEM report: FDA should disclose drug and device manufacturing information, Regulatory Focus 4 March 2022)
FDA has also long been concerned about the inability of some manufacturers to safely source and test ingredients susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination, which has resulted in poisonings worldwide. (RELATED: FDA issues blitz of warning letters over testing violations and refusing records requests, Regulatory focus 9 August 2023)
FDA is interested in obtaining the name and location of the API site, the manufacturer’s Data Universal Numbering System (DUNS) number and the API manufacturer facility establishment license (FEI) number, if available.
The agency also wants to know the date of the last FDA inspection; the names of all APIs manufactured at the facility, the API Unique Ingredient Identifier (UNII) code; the status of the API maker such as whether the sire is not manufacturing or whether the site is commercially available; and whether the site has an active US Drug Master File (DMF).
FDA wants to know the API manufacturer’s relationships with other drug manufacturers and sponsors; the company’s standing with regulators abroad and with FDA; and whether the facility is producing or can produce commercial quantities of the API.
The deadline for applying is 28 August; the contract runs from 25 September 2023 to 24 September 2024.
Applicants may contact Lilibeth Deato at [email protected] to apply.
RFQ
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