Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1AVT (Shanghai)
03 1Hangzhou Gaocheng Biotech & Health
04 2M B Sugars & Pharmaceuticals Ltd
05 1MEB Pharma
06 1Qualitek pharma
01 2China
02 4India
03 1U.S.A
01 5Active
02 2Blank
01 7Blank
01 7Blank
01 7Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23812
Submission : 2010-05-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26713
Submission : 2012-11-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33289
Submission : 2018-10-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26737
Submission : 2012-12-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35209
Submission : 2020-09-14
Status : Active
Type : IV
A Sucrose API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucrose API, including repackagers and relabelers. The FDA regulates Sucrose API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucrose API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Sucrose API supplier is an individual or a company that provides Sucrose API active pharmaceutical ingredient (API) or Sucrose API finished formulations upon request. The Sucrose API suppliers may include Sucrose API API manufacturers, exporters, distributors and traders.
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