EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Nortec Quimica
03 1ACS DOBFAR SPA
04 1Bayer AG
05 1Dasami Lab
06 1Fujifilm Diosynth Biotechnologies
07 1Gedeon Richter
08 1Medimpex
09 1Olon S.p.A
10 1Piramal Pharma Solutions
11 1Roche Diagnostics GmbH
12 1Tianjin Jinjin Pharmaceutical Co Ltd
13 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
14 1Yicheng Goto Pharmaceuticals Co Ltd
15 1ZHEJIANG LANGHUA PHARMACEUTICAL
16 1Zhejiang Shenzhou Pharmaceutical
17 1Zhejiang Xianju Pharmaceutical Co. Ltd
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-06
Pay. Date : 2013-01-23
DMF Number : 17264
Submission : 2004-03-26
Status :
Type : II
Nortec Quimica is the largest API manufacturer in Latin America.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37708
Submission : 2024-06-06
Status :
Type : II
A Spiractin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spiractin, including repackagers and relabelers. The FDA regulates Spiractin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spiractin 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 Spiractin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Spiractin supplier is an individual or a company that provides Spiractin active pharmaceutical ingredient (API) or Spiractin finished formulations upon request. The Spiractin suppliers may include Spiractin API manufacturers, exporters, distributors and traders.
click here to find a list of Spiractin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Spiractin DMF (Drug Master File) is a document detailing the whole manufacturing process of Spiractin active pharmaceutical ingredient (API) in detail. Different forms of Spiractin DMFs exist exist since differing nations have different regulations, such as Spiractin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spiractin DMF submitted to regulatory agencies in the US is known as a USDMF. Spiractin USDMF includes data on Spiractin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spiractin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Spiractin suppliers with USDMF on PharmaCompass.
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