Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 3TAPI Technology & API Services
03 1Mankind Pharma
04 1Lewens Labs
05 2Alivus Life Sciences
06 3Amoli Organics
07 1Apotex Pharmachem
08 2Aurobindo Pharma Limited
09 3Biocon
10 1CTX Lifesciences
11 2Changzhou Pharmaceutical Factory
12 2Chromo Laboratories
13 1HEC Pharm
14 1Hetero Drugs
15 1Innovare Labs
16 1Jiangsu Alpha Pharmaceutical Co., Ltd.
17 1Jubilant Generics
18 1KOLON Life Science, Inc
19 3Lek Pharmaceuticals
20 1Lupin Ltd
21 4MSN Laboratories
22 1Macleods Pharmaceuticals Limited
23 1Melody Healthcare
24 2Morepen Laboratories
25 1Ningbo Menovo Pharmaceutical
26 1Shanghai Desano Bio-Pharmaceutical
27 1Shanghai Wonder Pharmaceutical
28 1Sun Pharmaceutical Industries Limited
29 1Viatris
30 1ZHEJIANG MENOVO PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu
31 1Zhejiang Hisun Pharmaceutical
32 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.
33 2Zhejiang Yongtai Technology
34 1Zydus Lifesciences
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-17
Pay. Date : 2017-05-23
DMF Number : 31410
Submission : 2017-03-28
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 : 2013-01-31
Pay. Date : 2013-01-02
DMF Number : 20671
Submission : 2007-07-12
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-11
Pay. Date : 2022-06-07
DMF Number : 36493
Submission : 2021-12-22
Status :
Type : II
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39043
Submission : 2024-06-05
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 : 2016-12-23
Pay. Date : 2016-08-29
DMF Number : 30830
Submission : 2016-12-01
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 : 27879
Submission : 2014-02-07
Status :
Type : II
60
PharmaCompass offers a list of Rosuvastatin Calcium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Rosuvastatin Calcium manufacturer or Rosuvastatin Calcium supplier for your needs.
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A Fortius manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fortius, including repackagers and relabelers. The FDA regulates Fortius manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fortius API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Fortius supplier is an individual or a company that provides Fortius active pharmaceutical ingredient (API) or Fortius finished formulations upon request. The Fortius suppliers may include Fortius API manufacturers, exporters, distributors and traders.
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A Fortius DMF (Drug Master File) is a document detailing the whole manufacturing process of Fortius active pharmaceutical ingredient (API) in detail. Different forms of Fortius DMFs exist exist since differing nations have different regulations, such as Fortius USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fortius DMF submitted to regulatory agencies in the US is known as a USDMF. Fortius USDMF includes data on Fortius's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fortius USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fortius suppliers with USDMF on PharmaCompass.
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