Aspen API. More than just an API.
01 1Aspen API
02 1Hubei Gedian Humanwell Pharmaceutical
03 1CHEMO
04 1Guangzhou Tosun Pharmaceutical
05 1Industriale Chimica
06 1Ipca Laboratories
07 1LIBBS FARMO QUIMICA LTDA
08 1Merck & Co
09 1NEWCHEM SPA
10 1Nanjing Bold Chemical
11 1Qinhuangdao Zizhu Pharmaceutical
12 1Swati Spentose
13 1Symbiotica Specialty Ingredients
14 1Unipex
15 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
01 1Brazil
02 5China
03 1France
04 2India
05 2Italy
06 1Malaysia
07 1Netherlands
08 1Spain
09 1U.S.A
01 1Active
02 1Inactive
03 13Blank
01 6Valid
02 1Withdrawn by Holder
03 8Blank
01 15Blank
01 1WC-0402A2
02 14Blank
Certificate Number : R1-CEP 2012-173 - Rev 03
Issue Date : 2022-11-25
Type : Chemical
Substance Number : 1739
Status : Valid
Registrant Name : Synex Co., Ltd.
Registration Date : 2010-08-31
Registration Number : 20100831-140-H-28-01
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
NDC Package Code : 51508-010
Start Marketing Date : 2022-01-07
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 : 29217
Submission : 2015-03-26
Status : Active
Type : II
Certificate Number : R1-CEP 2015-015 - Rev 00
Issue Date : 2021-02-11
Type : Chemical
Substance Number : 1739
Status : Valid
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2014-03-07
Registration Number : 20140306-140-H-248-03
Manufacturer Name : Qinhuangdao Zizhu Pharmaceutical Co., Ltd.
Manufacturer Address : No.10, Longhai Road, Economic & Technological Development Zone, Qinhuangdao, Hebei, PRChina
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13895
Submission : 1998-12-14
Status : Inactive
Type : II
Certificate Number : R1-CEP 2011-124 - Rev 00
Issue Date : 2017-07-13
Type : Chemical
Substance Number : 1739
Status : Withdrawn by Holder
Certificate Number : R1-CEP 2009-336 - Rev 00
Issue Date : 2015-07-10
Type : Chemical
Substance Number : 1739
Status : Valid
NDC Package Code : 63190-0420
Start Marketing Date : 2011-07-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2021-11-10
Registration Number : 20110331-140-H-75-02(4)
Manufacturer Name : Industriale Chimica Srl
Manufacturer Address : Via EH Grieg, 13, 21047 SARONNO (VARESE), Italy
Date of Issue : 2020-09-08
Valid Till : 2023-04-24
Written Confirmation Number : WC-0402A2
Address of the Firm :
Certificate Number : R1-CEP 2012-329 - Rev 02
Issue Date : 2023-07-20
Type : Chemical
Substance Number : 1739
Status : Valid
NDC Package Code : 24002-0033
Start Marketing Date : 2009-09-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-07-15
Registration Number : 20210715-140-H-391-05
Manufacturer Name : Newchem SPA
Manufacturer Address : Via Roveggia, 47-37136 VERONA (VR), Italy
Certificate Number : R1-CEP 2012-142 - Rev 01
Issue Date : 2018-04-11
Type : Chemical
Substance Number : 1739
Status : Valid
Certificate Number : R1-CEP 2010-294 - Rev 00
Issue Date : 2016-12-14
Type : Chemical
Substance Number : 1739
Status : Valid
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2020-08-13
Registration Number : 20200813-140-H-373-04
Manufacturer Name : Symbiotica Specialty Ingredients Sdn. Bhd.
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
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