Aspen API. More than just an API.
01 1Aspen API
02 1CHEMO
03 1Guangzhou Tosun Pharmaceutical
04 1Industriale Chimica
05 1Ipca Laboratories
06 1LIBBS FARMO QUIMICA LTDA
07 1Merck & Co
08 1NEWCHEM SPA
09 1Nanjing Bold Chemical
10 1Qinhuangdao Zizhu Pharmaceutical
11 1Swati Spentose
12 1Symbiotica Specialty Ingredients
13 1Unipex
14 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
01 1Brazil
02 4China
03 1France
04 2India
05 2Italy
06 1Malaysia
07 1Netherlands
08 1Spain
09 1U.S.A
01 1Active
02 1Inactive
03 12Blank
01 6Valid
02 1Withdrawn by Holder
03 7Blank
01 14Blank
01 1WC-0402A2
02 13Blank
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
Available Reg Filing : ASMF, BR, CN |
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
Date of Issue : 2020-09-08
Valid Till : 2023-04-24
Written Confirmation Number : WC-0402A2
Address of the Firm :
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 : 2025-12-31
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
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Status : Withdrawn by Holder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 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
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
A Tibolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tibolone, including repackagers and relabelers. The FDA regulates Tibolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tibolone 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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