NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
Active Master IDIQ Awarded
- Federal agency
-
National Center for Advancing Translational Sciences
- Awardees
- 5
- Task orders
- 6
- Obligated
- $2,086,265
Vehicle facts
- Opportunity
-
- Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances Pre-Solicitation · 75N95023R00020 · Posted Apr 20, 2023
- Agency
-
- National Center for Advancing Translational Sciences National Institutes of Health, Department of Health and Human Services
- Combined task order value
-
- $2,086,265 Current, with exercised options
- $2,651,344 Potential, with all options
- Last date to order 35% complete
- Shared ceiling 4% used
- $49,713,679.00
IDV award and task order details come from SAM.gov/FPDS.
About this vehicle
The National Center for Advancing Translational Sciences at the National Institutes of Health established this Master IDIQ on May 15, 2024, to procure Chemistry, Manufacturing, and Controls services for the development of drug substances supporting preclinical and IND-enabling studies. Ordering authority extends through May 14, 2031, leaving approximately four years and nine months to place new task orders against a shared ceiling of $49.7 million.
Four task orders have been awarded since September 2024, generating $924 thousand in combined potential value with $870 thousand obligated (94 percent of combined potential). Ordering momentum is accelerating: one order in 2024 and three in 2025, indicating growing utilization. The scope spans process development, manufacturing in support of cGMP compliance, stability studies, and related CMC activities across multiple drug candidates. Recent orders include three-year stability study extensions on L-ENK and PTH-IA batches, extended stability studies on PTH-IA, and process development work on Telacebec for tuberculosis applications.
Two prime contractors dominate the awarded portfolio: Mriglobal holds one order valued at $796 thousand (86 percent of combined potential value), and Bachem Americas Inc. holds three orders valued at $128 thousand combined. No competitive concentration risk yet exists at the vehicle level given the sparse award history, but Mriglobal's single large order represents substantial scope depth. All four orders are unrestricted (no set-aside).
Customer agencies are split between NCATS itself, which has funded two orders worth $822 thousand combined, and the National Institute on Drug Abuse, which has funded two orders worth $101 thousand combined. Task-order values range from $26.4 thousand to $795.9 thousand (ceiling), with durations spanning from approximately 21 months to 36 months. Pricing has been both Firm Fixed Price and Cost Plus Fixed Fee. The vehicle remains lightly obligated against its $49.7 million ceiling, with substantial capacity remaining for new work.
IDV awards
Latest task orders
| Task order | Awardee | Awarding agency | Obligated | Last action |
|---|---|---|---|---|
| Manufacture of GMP batch H105A peptide | Polypeptide Laboratories San Diego, LLC | NIDA | $601,000 | |
| Process development and manufacture of AZM152 | Polypeptide Laboratories San Diego, LLC | NIDA | $315,000 | |
| Process development of telacebec for tuberculosis | Mriglobal | NIDA | $1,042,565 | |
| Task order award. Chemistry, manufacturing and controls and related services… | Bachem Americas Inc. | NIDA | $56,100 | |
| Task order award. Chemistry, manufacturing and controls and related services… | Bachem Americas Inc. | NIDA | $45,200 | |
| Extended stability studies of PTH-IA | Bachem Americas Inc. | NIDA | $26,400 |
Top awardees by obligations
| Rank | Awardee | Obligated | Share |
|---|---|---|---|
| 1 | Mriglobal | $1,042,565 | 50% |
| 2 | Polypeptide Laboratories San Diego, LLC | $916,000 | 44% |
| 3 | Bachem Americas Inc. | $127,700 | 6% |
Top funding agencies by obligations
| Rank | Funding agency | Obligated | Share |
|---|---|---|---|
| 1 | Department of Health and Human Services | $2,086,265 | 100% |
Obligations by fiscal year
| Fiscal year | Obligated |
|---|---|
| FY2026 | $1,216,673 |
| FY2025 | $264,305 |
| FY2024 | $605,287 |
Quick answers
What is the NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances contract vehicle?
NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances is an indefinite delivery, indefinite quantity (IDIQ) contract vehicle run by National Center for Advancing Translational Sciences (National Institutes of Health), awarded on May 15, 2024.
Which companies hold NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances?
5 companies hold NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances's IDV awards, one each. The latest went to Mriglobal on May 15, 2024. The awardees whose task orders obligated the most are Mriglobal, Polypeptide Laboratories San Diego, LLC and Bachem Americas Inc.
How much has been spent through NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances?
6 task orders have been placed under NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances, obligating $2,086,265.
What is the shared ceiling of NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances?
NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances's shared ceiling is $49,713,679; its task orders have used 4% of it.
Which agencies use NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances the most?
The departments whose task orders under NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances obligated the most are Department of Health and Human Services ($2,086,265).
How much was obligated through NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances in fiscal year 2025?
Task orders under NCATS Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances obligated $264,305 in fiscal year 2025.
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