Pfanstiehl

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35277

Submission : 2020-10-08

Status : Active

Type : IV

Excipients Web Link

02

A, A TREHALOSE DIHYDRATE, IN...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35182

Submission : 2020-09-09

Status : Active

Type : IV

Excipients Web Link

03

A, A-TREHALOSE DIHYDRATE, HI...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24122

Submission : 2010-08-30

Status : Active

Type : IV

Excipients Web Link

04

D-GALACTOSE, PLANT DERIVED H...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38846

Submission : 2023-09-20

Status : Active

Type : IV

Excipients Web Link

05

D-MANNITOL (PLANT DERIVED) H...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32464

Submission : 2018-02-15

Status : Active

Type : IV

Excipients Web Link

06

L-ARGININE HYDROCHLORIDE, HI...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38077

Submission : 2023-02-17

Status : Active

Type : IV

Excipients Web Link

07

L-ARGININE, HIGH PURITY, LOW...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38012

Submission : 2023-01-31

Status : Active

Type : IV

Excipients Web Link

08

L-HISTIDINE HYDROCHLORIDE MO...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39170

Submission : 2023-11-28

Status : Active

Type : IV

Excipients Web Link

09

L-HISTIDINE, HIGH PURITY, LO...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38409

Submission : 2023-05-25

Status : Active

Type : IV

Excipients Web Link

10

L-METHIONINE, HIGH PURITY, L...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38284

Submission : 2023-04-24

Status : Active

Type : IV

Excipients Web Link