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02 1ALP Pharm
03 1Aurobindo Pharma Limited
04 2Cheer Fine Pharmaceutical
05 1Daiwa Pharmaceuticals
06 1Huvepharma Italia S.r.l
07 1Icrom
08 1Jiangsu Nhwa Pharmaceutical
09 1Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. CN 223 002 Huai'an
10 1Olon S.p.A
11 1Qingdao Qingmei Biotech
12 1Unipex
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01 3Valid
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01 1217MF10507
02 1218MF10084
03 1220MF10210
04 1229MF10008
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20209
Submission : 2007-01-05
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-073 - Rev 09
Issue Date : 2021-04-27
Type : Chemical
Substance Number : 1045
Status : Valid
Certificate Number : R1-CEP 2011-074 - Rev 03
Issue Date : 2023-03-13
Type : Chemical
Substance Number : 1045
Status : Valid
Registration Number : 218MF10084
Registrant's Address : Via Delle Arti 33, 20863 Concorezzo (MB), Italy
Initial Date of Registration : 2006-01-27
Latest Date of Registration :
Registrant Name : Taegeuk Pharmaceutical Co., Ltd.
Registration Date : 2012-07-27
Registration Number : 20110812-124-H-58-01(2)
Manufacturer Name : ICROM SpA
Manufacturer Address : Via Delle Arti 33 (via Primo Maggio 36 secondary gate)20049 Concorezzo, Milan
Certificate Number : R1-CEP 2005-077 - Rev 02
Issue Date : 2017-09-15
Type : Chemical
Substance Number : 1045
Status : Valid
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2017-09-07
Registration Number : 20170907-124-H-319-02
Manufacturer Name : Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
Manufacturer Address : No.168, West Chaoyang Road, Qingpu Industrial Park, Huai'an Jiangsu, China
Registration Number : 217MF10507
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-09-06
Latest Date of Registration :
Registration Number : 229MF10008
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province, China
Initial Date of Registration : 2017-01-10
Latest Date of Registration :
Registration Number : 220MF10210
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province, China
Initial Date of Registration : 2008-09-30
Latest Date of Registration :
A Espiride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Espiride, including repackagers and relabelers. The FDA regulates Espiride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Espiride 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 Espiride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Espiride supplier is an individual or a company that provides Espiride active pharmaceutical ingredient (API) or Espiride finished formulations upon request. The Espiride suppliers may include Espiride API manufacturers, exporters, distributors and traders.
click here to find a list of Espiride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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