01 1AbbVie Inc. North Chicago US
02 1TEVA CZECH INDUSTRIES S.R.O. Opava CZ
03 1TEVA PHARMACEUTICAL INDUSTRIES LTD Petach Tikva IL
04 1Apotex Fermentation Inc. Winnipeg CA
05 1CKD BIO CORPORATION Ansan-si KR
06 1CONCORD BIOTECH LIMITED Ahmedabad IN
07 1CURIA ITALY S.R.L. Rozzano, Milano IT
08 1HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN
09 1North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN
10 1TAISHAN CITY CHEMICAL PHARMACEUTICAL CO., LTD. Taishan City CN
11 1Zhejiang Ruibang Laboratories Wenzhou CN
Certificate Number : R1-CEP 1998-093 - Rev 07
Status : Valid
Issue Date : 2020-10-09
Type : Chemical and TSE
Substance Number : 994
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : R1-CEP 2002-152 - Rev 06
Status : Valid
Issue Date : 2023-06-21
Type : Chemical
Substance Number : 994
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : R1-CEP 1997-045 - Rev 05
Status : Withdrawn by Holder
Issue Date : 2017-11-02
Type : Chemical
Substance Number : 994
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 CEP of the European Pharmacopoeia monograph is often referred to as a Restasis Certificate of Suitability (COS). The purpose of a Restasis CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Restasis EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Restasis to their clients by showing that a Restasis CEP has been issued for it. The manufacturer submits a Restasis CEP (COS) as part of the market authorization procedure, and it takes on the role of a Restasis CEP holder for the record. Additionally, the data presented in the Restasis CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Restasis DMF.
A Restasis CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Restasis CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Restasis suppliers with CEP (COS) on PharmaCompass.
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