Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1ACS DOBFAR SPA
03 1AVT (Shanghai)
04 2Ajinomoto Company
05 2CordenPharma
06 1Fuan Pharmaceutical
07 1Hangzhou Think Chemical Co.Ltd
08 2Jing Jing Pharmaceutical
09 1Kyowa Hakko Bio
10 1Mitsubishi Tanabe Pharma
11 2Orchid Pharma
12 1Yangzhou Gami Biochem Co. Ltd
01 6China
02 2Germany
03 2India
04 1Italy
05 4Japan
06 1U.S.A
01 7Active
02 2Inactive
03 7Blank
01 1Valid
02 15Blank
01 1218MF10640
02 1218MF10702
03 14Blank
01 16Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-04
Pay. Date : 2020-11-30
DMF Number : 31646
Submission : 2017-04-20
Status : Active
Type : II
Certificate Number : R0-CEP 2022-190 - Rev 00
Issue Date : 2022-09-29
Type : Chemical
Substance Number : 806
Status : Valid
Registration Number : 218MF10640
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2006-07-20
Latest Date of Registration : --
NDC Package Code : 17333-002
Start Marketing Date : 2002-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39434
Submission : 2024-04-30
Status : Active
Type : IV
NDC Package Code : 17333-002
Start Marketing Date : 2002-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18843
Submission : 2005-10-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-09
Pay. Date : 2021-08-04
DMF Number : 18923
Submission : 2005-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39677
Submission : 2024-04-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22918
Submission : 2009-06-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-04
Pay. Date : 2014-05-23
DMF Number : 28191
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10131
Submission : 1989-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1929
Submission : 1972-05-09
Status : Inactive
Type : II
A L-Arginine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Arginine, including repackagers and relabelers. The FDA regulates L-Arginine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Arginine 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 L-Arginine supplier is an individual or a company that provides L-Arginine active pharmaceutical ingredient (API) or L-Arginine finished formulations upon request. The L-Arginine suppliers may include L-Arginine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Arginine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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