Overview
AMINO GMBH is an active pharmaceutical ingredient (API) supplier with 15 active FDA Type II Drug Master Files, covering BETAINE; BETAINE PHARMACEUTICAL GRADE; L-ALANINE; L-ASPARTIC ACID; L-HISTIDINE; L-ISOLEUCINE.
API / Drug Master Files
AMINO GMBH holds 15 active (17 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.
- L-ALANINEActive2023-11-30
- L-HISTIDINEActive2023-11-30
- L-METHIONINEActive2023-11-30
- L-THREONINEActive2020-03-27
- L-ASPARTIC ACIDActive2020-01-27
- BETAINE PHARMACEUTICAL GRADEActive2017-03-28
- L-LEUCINE FROM FERMENTATIONActive2016-12-14
- N-ACETYL-L-TYROSINEActive1997-10-29
- L-VALINEActive1997-10-29
- BETAINEActive1994-09-08
- L-TRYPTOPHANActive1989-10-24
- L-TYROSINEActive1982-07-16
- L-PHENYLALANINEActive1980-10-22
- L-ISOLEUCINEActive1980-10-22
- L-LEUCINEActive1980-06-11
Showing 15 of 17 Drug Master Files.
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to AMINO GMBH in our records. PharmaTek screens the full directory against live FDA enforcement data.
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