NIH Reporter #75N91019D00024-0-759102500021-1

Manufacture and Supply of GMP-Grade Hydroxocobalamin for NIH/NCI

This opportunity is for the manufacturing and delivery of GMP-grade Hydroxocobalamin for the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). - Government Buyer: - National Cancer Institute (NCI), National Institutes of Health (NIH) - Products/Services Requested: - Manufacture a 2 Kg batch of Hydroxocobalamin (OHCbl) under Good Manufacturing Practice (GMP) conditions - Deliverables must include: - Certificate of Analysis (COA) - Quality Overall Summary (Module 2.3.S) or Drug Master File (DMF) number - Material Safety Data Sheet (MSDS) - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Unique/Notable Requirements: - Strict adherence to GMP manufacturing standards - Comprehensive documentation for quality and safety is mandatory - The product is intended for use in cancer research or treatment applications - Estimated contract value: $61,516 - Location: Frederick, Maryland

Description

This contract is for generating a 2 Kg GMP batch of Hydroxocobalamin (OHCbl). The contractor is required to provide the Certificate of Analysis (COA), a Quality Overall Summary (Module 2.3.S) or a DMF file number, and a material safety data sheet. The project duration is from September 15, 2025 to September 14, 2026. The estimated contract value is $61,516. No pre-bid meeting or response due date is specified.

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