Aspen API. More than just an API.
01 1Aspen Oss BV
02 3INDUSTRIAL CHIMICA SRL
03 1Industriale Chimica Srl
04 1Industriale Chimica srl
05 1Newchem SPA
06 1Qinhuangdao Zizhu Pharmaceutical Co., Ltd.
07 1Symbiotica Specialty Ingredients Sdn. Bhd.
01 1Alvogen Korea Co., Ltd.
02 1Darim Biotech Co., Ltd.
03 1GL Pharma Co., Ltd.
04 1Iksoo Pharmaceutical Co., Ltd.
05 1Kukjeon Pharmaceutical Co., Ltd.
06 1Myungmoon Pharmaceutical Co., Ltd.
07 1Pami Future Co., Ltd.
08 1Sungjin Exim Co., Ltd.
09 1Synex Co., Ltd.
01 9Tibolon
01 1China
02 6Italy
03 1Malaysia
04 1Netherlands
Aspen API. More than just an API.
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
Registrant Name : Darim Biotech Co., Ltd.
Registration Date : 2016-12-07
Registration Number : 20110331-140-H-75-02(1)
Manufacturer Name : INDUSTRIAL CHIMICA SRL
Manufacturer Address : VIA EH Grieg 13 20147 SARONNO (VARESE), ITALY
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
Registrant Name : Myungmoon Pharmaceutical Co., Ltd.
Registration Date : 2020-09-08
Registration Number : 20110331-140-H-75-02(3)
Manufacturer Name : INDUSTRIAL CHIMICA SRL
Manufacturer Address : VIA EH Grieg 13 21047 SARONNO (VARESE), ITALY
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2011-03-31
Registration Number : 20110331-140-H-75-02
Manufacturer Name : INDUSTRIAL CHIMICA SRL
Manufacturer Address : VIA EH Grieg 13 21047 SARONNO (VARESE), ITALY
Registrant Name : GL Pharma Co., Ltd.
Registration Date : 2019-10-30
Registration Number : 20110331-140-H-75-02(2)
Manufacturer Name : Industriale Chimica srl
Manufacturer Address : via EHGrieg 13 21047 - Saronno (Varese), Italy
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
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2014-03-07
Registration Number : 20140306-140-H-248-03
Manufacturer Name : Qinhuangdao Zizhu Pharmaceut...
Manufacturer Address : No.10, Longhai Road, Economic & Technological Development Zone, Qinhuangdao, Hebei, P...
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2020-08-13
Registration Number : 20200813-140-H-373-04
Manufacturer Name : Symbiotica Specialty Ingredi...
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
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.
click here to find a list of Tibolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tibolone supplier is an individual or a company that provides Tibolone active pharmaceutical ingredient (API) or Tibolone finished formulations upon request. The Tibolone suppliers may include Tibolone API manufacturers, exporters, distributors and traders.
click here to find a list of Tibolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tibolone Drug Master File in Korea (Tibolone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tibolone. The MFDS reviews the Tibolone KDMF as part of the drug registration process and uses the information provided in the Tibolone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tibolone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tibolone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tibolone suppliers with KDMF on PharmaCompass.
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