KREITCHMAN PET CENTER
Overview
KREITCHMAN PET CENTER is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering [11C]-MDL100907; EKAP C11 INJECTION; FPEB F18 INJECTION; MEFWAY F18 (PET DRUG); PBR28 C11 INJECTION; THK-5351 F18 INJECTION.
Core services & business areas
API / Drug Master Files
KREITCHMAN PET CENTER holds 6 active (6 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.
- EKAP C11 INJECTIONActive2022-08-25
- MEFWAY F18 (PET DRUG)Active2021-10-19
- THK-5351 F18 INJECTIONActive2016-01-04
- FPEB F18 INJECTIONActive2015-06-15
- PBR28 C11 INJECTIONActive2014-12-03
- [11C]-MDL100907Active2013-10-21
FDA compliance signals
3 FDA enforcement records linked to this company.
- 4832017-12-15
Analytical methods
- 4832017-12-15
Written QA procedures established, followed
- 4832017-12-15
Personnel not qualified
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