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

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01 1Pfanstiehl
02 1Willow Birch Pharma
03 1Anlon Healthcare Ltd
04 1ACS DOBFAR SPA
05 1AVT (Shanghai)
06 2Ajinomoto Company
07 2CordenPharma
08 1Fuan Pharmaceutical
09 1Hangzhou Think Chemical Co.Ltd
10 2Jing Jing Pharmaceutical
11 1Kyowa Hakko Bio
12 1Mitsubishi Tanabe Pharma
13 2Orchid Pharma
14 1Spectrum Chemical
15 1Tianjin Tianfa Pharmaceutical Import & Export
16 1Yangzhou Gami Biochem Co. Ltd
17 1Yichang Sanxia Pharmaceutical
18 2Blank
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01 8China
02 2Germany
03 3India
04 1Italy
05 4Japan
06 3U.S.A
07 2Blank
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01 7Active
02 2Inactive
03 14Blank
01 1Valid
02 22Blank
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01 1218MF10640
02 1218MF10702
03 21Blank
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01 23Blank
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01 23Blank
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01 210695-320
02 112497-1004
03 117333-002
04 149452-0706
05 174920-003
06 17Blank
01 23Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
NDC Package Code : 10695-320
Start Marketing Date : 2025-09-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
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 : 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 : 39677
Submission : 2024-04-08
Status : Active
Type : IV

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

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A NCGC00024715-04 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00024715-04, including repackagers and relabelers. The FDA regulates NCGC00024715-04 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00024715-04 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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We have 17 companies offering NCGC00024715-04
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