AMINO GMBH

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.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances AMINO GMBH is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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-METHIONINEActive2023-11-30
• L-ALANINEActive2023-11-30
• L-HISTIDINEActive2023-11-30
• L-THREONINEActive2020-03-27
• L-ASPARTIC ACIDActive2020-01-27
• BETAINE PHARMACEUTICAL GRADEActive2017-03-28
• L-LEUCINE FROM FERMENTATIONActive2016-12-14
• L-VALINEActive1997-10-29
• N-ACETYL-L-TYROSINEActive1997-10-29
• 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.