Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
Active Master IDIQ Awarded
- Federal agency
-
National Center for Advancing Translational Sciences
- Awardees
- 5
- Task orders
- 1
- Obligated
- $382,010
Vehicle facts
- Opportunity
-
- Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products Pre-Solicitation · 75N95023R00037 · Posted May 30, 2023
- Agency
-
- National Center for Advancing Translational Sciences National Institutes of Health, Department of Health and Human Services
- Combined task order value
- $382,010 Current and potential, with all options
- Last date to order 32% complete
- Shared ceiling 1% used
- $49,885,703.00
IDV award and task order details come from SAM.gov/FPDS.
About this vehicle
The National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health established a Master IDIQ for Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products on August 12, 2024, with ordering authority extending through July 31, 2031. The vehicle carries a shared ceiling of $49.885 million and is unrestricted—no set-aside applied to the vehicle or its task orders.
Only one task order has been awarded to date: a firm-fixed-price delivery order to Vitae Enim Vitae Scientific, Inc. in September 2024 for dosage form reprocess and stability studies of FX-5A Injection, valued at $382 thousand with an ultimate completion date of May 31, 2028. The full potential value of $382 thousand has been obligated against this single award. The sole customer agency to date is the National Institute on Drug Abuse (NIDA), part of NIH.
The scope reflects NCATS's Therapeutic Development Branch mission: chemistry, manufacturing, and controls services for drug product development, encompassing formulation, manufacturing, and quality assurance in support of preclinical, IND-enabling, and clinical studies. Contractors provide a broad range of preclinical services including design, development, manufacture, and release of drug products and clinical trial material; all activities preliminary to GMP manufacturing (development lots, formulation studies, engineering work) are in scope, as are ancillary products such as placebos, diluents, adjuvants, master cell banks, reference standards, and related testing.
With five-plus years of ordering authority remaining and only one modest award placed in the first year, the vehicle remains in very early stages of execution. Competition is currently non-existent at the prime level (one awardee), though the unrestricted set-aside structure and $49.885 million ceiling suggest the Government intends broader competition as demand develops. For business development purposes, this vehicle represents an emerging contract vehicle with substantial ordering runway and little incumbent advantage to date; pursuit depends on capability in drug-product CMC and preclinical manufacturing support aligned with NCATS's translational research agenda.
IDV awards
Latest task orders
| Task order | Awardee | Awarding agency | Obligated | Last action |
|---|---|---|---|---|
| Dosage form reprocess and stability studies of FX-5A injection under IDIQ… | Vitae Enim Vitae Scientific, Inc. | NIDA | $382,010 |
Top awardees by obligations
| Rank | Awardee | Obligated | Share |
|---|---|---|---|
| 1 | Vitae Enim Vitae Scientific, Inc. | $382,010 | 100% |
Top funding agencies by obligations
| Rank | Funding agency | Obligated | Share |
|---|---|---|---|
| 1 | Department of Health and Human Services | $382,010 | 100% |
Obligations by fiscal year
| Fiscal year | Obligated |
|---|---|
| FY2026 | $59,082 |
| FY2024 | $322,928 |
Quick answers
What is the Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products contract vehicle?
Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products is an indefinite delivery, indefinite quantity (IDIQ) contract vehicle run by National Center for Advancing Translational Sciences (National Institutes of Health), awarded on August 12, 2024.
Which companies hold Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products?
5 companies hold Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products's IDV awards, one each. The latest went to Purdue University on August 12, 2024. The awardees whose task orders obligated the most are Vitae Enim Vitae Scientific, Inc.
How much has been spent through Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products?
1 task order has been placed under Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products, obligating $382,010.
What is the shared ceiling of Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products?
Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products's shared ceiling is $49,885,703; its task orders have used 1% of it.
Which agencies use Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products the most?
The departments whose task orders under Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products obligated the most are Department of Health and Human Services ($382,010).
On GovTribe
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