3D Imaging Drug Design and Development LLC
Overview
3D Imaging Drug Design and Development LLC is a private biopharmaceutical company that utilizes advanced 3D imaging technology to revolutionize drug design and development. The company is dedicated to improving therapeutic outcomes through innovative research and development processes.
Core services & business areas
Therapeutic areas
API / Drug Master Files
3D Imaging Drug Design and Development LLC holds 13 active (15 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- "89ZR-LINTUZUMAB INJECTIONActive2026-04-28
- Zr89-YS5Active2024-10-01
- I-124 HJAA-F11Active2024-09-17
- ZR89 OXINEActive2021-08-09
- 89 ZR-DARATUMUMABActive2020-12-31
- (F-18) CLOFARABINEActive2020-10-06
- 89ZR-DINUTUXIMABActive2020-07-29
- ZIRCONIUM-89 OXALATEActive2017-02-22
- I-124-MIBG INJECTIONActive2014-10-27
- DPA-713 I 124 INJECTIONActive2013-10-01
- FLUOROMISONIDAZOLE F 18 INJECTIONActive2013-07-19
- SODIUM IODIDE I 124Active2012-03-23
- [I-124] FIAU (FIALURIDINE)Active2010-07-23
- [I-124]CLR1404 INJECTIONInactive2013-12-27
- [F-18] FDPNInactive2010-09-15
FDA compliance signals
12 FDA enforcement records linked to this company.
- warning_letter2025-12-04
FDA Warning Letter (drug product)
- 4832024-01-31
Failure to develop written procedures
- 4832017-04-20
Prevention of contamination
- 4832017-04-20
Written QA procedures established, followed
- 4832017-04-20
Determination need for investigation
- 4832017-04-20
Equipment not clean
- 4832017-04-20
Testing Procedures- Conformance to Standards
- 4832017-04-20
Failure to develop written procedures
- 4832017-04-20
Adequate controls (general)
- 4832017-04-20
Use of reliable suppliers
- 4832017-04-20
Lab written procedures
- 4832017-04-20
Master Production and Control Records
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