01 1AbbVie Inc
02 4TAPI Technology & API Services
03 1Actavis Inc
04 1Apotex Pharmachem
05 1CKD Bio Corporation
06 2Catalent Pharma Solutions
07 1Concord Biotech
08 2Curia
09 1Fujian Kerui Pharmaceutical Co Ltd
10 1GALENA AS
11 1Hangzhou Zhongmei Huadong Pharmaceutical
12 2North China Pharmaceutical Co., Ltd.
13 1North China Pharmaceutical Huasheng Co Ltd
14 1Ruibang Laboratories
15 1Sandoz B2B
16 2Zhejiang Ruibang Laboratories
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13800
Submission : 1998-09-01
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-07
DMF Number : 12932
Submission : 1998-04-02
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13799
Submission : 1998-09-01
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34642
Submission : 2020-03-11
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-18
Pay. Date : 2015-07-22
DMF Number : 29557
Submission : 2015-07-30
Status :
Type : II
A Restasis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Restasis, including repackagers and relabelers. The FDA regulates Restasis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Restasis 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 Restasis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Restasis supplier is an individual or a company that provides Restasis active pharmaceutical ingredient (API) or Restasis finished formulations upon request. The Restasis suppliers may include Restasis API manufacturers, exporters, distributors and traders.
click here to find a list of Restasis suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Restasis DMF (Drug Master File) is a document detailing the whole manufacturing process of Restasis active pharmaceutical ingredient (API) in detail. Different forms of Restasis DMFs exist exist since differing nations have different regulations, such as Restasis USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Restasis DMF submitted to regulatory agencies in the US is known as a USDMF. Restasis USDMF includes data on Restasis's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Restasis USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Restasis suppliers with USDMF on PharmaCompass.
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