EXTRA-19822 - USA (Beltsville, Maryland) - Active Pharmaceutical Ingredients Manufacturer Data Acquisition Service - Deadline July 8,2022

Product (RFP/RFQ/RFI/Solicitation/Tender/Bid Etc.) ID: EXTRA-19822

Government Authority located in Beltsville, Maryland; USA based organization looking for expert vendor for active pharmaceutical ingredients manufacturer data acquisition service.

[A] Budget: Looking for Proposal

[B] Scope of Service:

(1) Vendor needs to provide active pharmaceutical ingredients (API) manufacturer data acquisition service to assist in programs that rely on manufacturing information for the purposes of compliance, surveillance, enforcement, drug shortages and user fee collections to the government authority located in Beltsville, MD.
- Relationships with other drug manufacturers and Sponsors
- Regulator standing abroad and domestically
- Presence of drug master file (DMF) licenses
- The facility is producing or is capable of producing commercial quantities of the API
- The site is in the developmental process, and has the capacity to manufacture the API
- Facility is currently not manufacturing this API, but had at some time in the past manufactured this API
- API Manufacturer Company Name
- API Manufacturer Company Street Address
- API Manufacturer Company City
- API Manufacturer Company Country
- API Manufacturer Unique numeric identifier, referred to as a DUNS (Data Universal Numbering System) Number.
- API Manufacturer FEI Number
- API Manufacturer Latest FDA Inspection Date
- API Manufacturer Corporate Group Name
- API Manufacturer Corporate Group Country
- Names of all API’s manufactured at the facility
- API Unique Ingredient Identifier (UNII) code
- Manufacturing Status
(2) The contract period will be for one year.

[C] Eligibility:

- Onshore (USA ONLY);

[D] Work Performance:

Performance of the work will be Offsite.

Expiry Date : Friday, 8 July, 2022

Category : Professional, Consulting, Administrative or Management Support Services, Marketing and Branding

Country : USA

State : Maryland

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