Drug Formulation and Manufacturing Contracts 2019

Ended Master IDIQ Awarded

Federal agency
Awardees
5
Task orders
14
Obligated
$5,766,604

Vehicle facts

Opportunity
  • 75N98019R00005 Solicitation number
Agency
Combined task order value
  • $5,766,604 Current, with exercised options
  • $5,992,016 Potential, with all options
Last date to order 100% complete
Shared ceiling 13% used
$45,000,250.00

IDV award and task order details come from SAM.gov/FPDS.

About this vehicle

The National Institutes of Health Office of Logistics and Acquisition Operations awarded this master IDIQ for drug formulation and manufacturing on September 27, 2019, with a shared ceiling of $45 million; ordering closed on September 27, 2024, and is no longer active.

The vehicle funds development and manufacture of dosage forms of small-molecule drug candidates for preclinical efficacy studies, Investigational New Drug enabling studies, and clinical trials across NIH institutes. Task orders executed to date show heavy emphasis on production of GMP and engineering batches of specialized capsules and injectables—including AZA-TDC, Z-Endoxifen, TAK-243, ATTM, Novobiocin, Triapine, and Ketamine formulations—paired with stability testing and shelf-life studies of finished pharmaceutical products and active pharmaceutical ingredients. Pricing is predominantly firm fixed price with one cost-plus-fixed-fee order.

Three prime contractors shared the 14 task orders awarded through April 2024. Mriglobal holds the largest combined potential value at $3.4 million across three orders, while Societal CDMO San Diego, LLC won ten orders worth $2.5 million combined, and Alchem Laboratories Corporation received one order for $180 thousand. The vehicle is unrestricted at the vehicle level; 93% of task orders carried no set-aside, with one order designated partial small business.

The National Cancer Institute drove demand with ten orders totaling $3.6 million in combined potential value, followed by the Office of Logistics and Acquisition Operations itself with three orders worth $2.3 million. The National Institute on Aging placed one order for $100 thousand. Obligated spend reached $5.8 million against $6 million combined potential value across all task orders (96% obligation rate), indicating heavy drawdown of the vehicle before ordering window closed. Task-order values ranged from $10 thousand to $2.3 million, with the Ketamine production order representing the largest single award. Ordering momentum declined sharply in 2024, with only one order placed before the vehicle's September 2024 cutoff after consistent three-order annual pace in prior years.

Description

The Drug Formulation and Manufacturing Contracts (DFMC) will allow NIH ICs to hire contractors to conduct the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials.

IDV awards

Latest task orders

Task order Awardee Awarding agency Obligated Last action
Evaluation of shelf-life of samples of investigational clinical drug… 75N91023F00001 Mriglobal NCI $949,295
IDP production for the ketamine program-quote # NIH-olao 0001 75N98020F00001 Mriglobal OLAO $2,310,582
Dfmc- the purpose of this task order is to manufacture and deliver 2200… 75N91024F00001 Alchem Laboratories Corporation NCI $180,220
Production of a cgmp batch of triapine injection 75N91021F00062 Societal Cdmo San Diego, LLC NCI $249,950
Next DTP-23-017, production of 0.25MG of azatdc and tdcyd capsules 75N91023F00001 Societal Cdmo San Diego, LLC NCI $66,182
Next DTP-22-013, production of TAK-243 injectable for clinical use and study… 75N91022F00003 Societal Cdmo San Diego, LLC NCI $620,051
Drug toxicity testing 75N98024F00001 Mriglobal OLAO $99,500
Production of an engineering batch, cgmp batch, delivery, and shelf-life… 75N91022F00002 Societal Cdmo San Diego, LLC NCI $321,255
AZA-TDC capsules for use in clinical trial for possible cancer treatment. The… 75N91022F00001 Societal Cdmo San Diego, LLC NCI $153,336
Development & manufacture of oral & topical dosage forms - novobiocin capsule… 75N91021F00107 Societal Cdmo San Diego, LLC NCI $505,500
Next DTP-22-018, GMP production of 40 MG z-endoxifen (NSC 774768) capsules… 75N91022F00004 Societal Cdmo San Diego, LLC NCI $149,535
DTP-23-019 PRB next, production of 40MG capsules of z-endoxifen 75N91023F00002 Societal Cdmo San Diego, LLC NCI $140,000
Irisys, LLC [20-054906] stability drug testing of decitabine capsules according… 75N98020F00001 Societal Cdmo San Diego, LLC OLAO $10,198
Irisys, LLC [20-054996] stability study required by GMP for finished… 75N98020F00002 Societal Cdmo San Diego, LLC OLAO $11,000
Show all 14

Top awardees by obligations

Rank Awardee Obligated Share
1 Mriglobal $3,359,377 58%
2 Societal Cdmo San Diego, LLC $2,227,007 39%
3 Alchem Laboratories Corporation $180,220 3%

Top funding agencies by obligations

Rank Funding agency Obligated Share
1 Department of Health and Human Services $5,766,604 100%

Obligations by fiscal year

Fiscal year Obligated
FY2025 $124,460
FY2024 $417,942
FY2023 $1,143,528
FY2022 $1,433,881
FY2021 $1,412,451
FY2020 $1,234,343

Quick answers

What is the Drug Formulation and Manufacturing Contracts 2019 contract vehicle?

Drug Formulation and Manufacturing Contracts 2019 is an indefinite delivery, indefinite quantity (IDIQ) contract vehicle run by Office of Logisitics and Acquisition Operations (National Institutes of Health), awarded on September 27, 2019.

Which companies hold Drug Formulation and Manufacturing Contracts 2019?

5 companies hold Drug Formulation and Manufacturing Contracts 2019's IDV awards, one each. The latest went to Societal Cdmo San Diego, LLC on September 27, 2019. The awardees whose task orders obligated the most are Mriglobal, Societal Cdmo San Diego, LLC and Alchem Laboratories Corporation.

How much has been spent through Drug Formulation and Manufacturing Contracts 2019?

14 task orders have been placed under Drug Formulation and Manufacturing Contracts 2019, obligating $5,766,604.

What is the shared ceiling of Drug Formulation and Manufacturing Contracts 2019?

Drug Formulation and Manufacturing Contracts 2019's shared ceiling is $45,000,250; its task orders have used 13% of it.

Which agencies use Drug Formulation and Manufacturing Contracts 2019 the most?

The departments whose task orders under Drug Formulation and Manufacturing Contracts 2019 obligated the most are Department of Health and Human Services ($5,766,604).

How much was obligated through Drug Formulation and Manufacturing Contracts 2019 in fiscal year 2025?

Task orders under Drug Formulation and Manufacturing Contracts 2019 obligated $124,460 in fiscal year 2025.

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