Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 6Dr. Reddy's Laboratories
03 1ALP Pharm
04 1Amoli Organics
05 1Apotex Pharmachem
06 2Arch Pharmalabs
07 1Asymchem Laboratories
08 1Aurobindo Pharma Limited
09 3Biocon
10 2Cadila Pharmaceuticals
11 1Changzhou Pharmaceutical Factory
12 1Chromo Laboratories
13 1EPHAR BIOLOGICAL AND CHEMICAL CO LTD
14 1HEC Pharm
15 2Hetero Drugs
16 1Ind Swift Laboratories Limited
17 1Jiangsu Alpha Pharmaceutical Co., Ltd.
18 1Jubilant Generics
19 1Laurus Labs
20 1Lek Pharmaceuticals
21 3Lupin Ltd
22 3MSN Laboratories
23 2Macleods Pharmaceuticals Limited
24 2Mankind Pharma
25 3Morepen Laboratories
26 1Par Pharmaceutical
27 1Pfizer Inc
28 1Raks Pharma
29 1Signa S.A. de C.V.
30 4Sun Pharmaceutical Industries Limited
31 1Teva Pharmaceutical Industries
32 1Torrent Pharmaceuticals Limited
33 1Viatris
34 1Vijayasri Organics Limited
35 1Zhejiang Haisen Pharmaceutical Co., Ltd.
36 1Zhejiang Hisun Pharmaceutical
37 1Zhejiang Jiangbei Pharmaceutical
38 3Zhejiang Neo-Dankong Pharm. Co.,Ltd.
39 4Zydus 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 : 2016-05-31
Pay. Date : 2015-08-20
DMF Number : 29520
Submission : 2015-08-03
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-27
Pay. Date : 2013-02-05
DMF Number : 18468
Submission : 2005-06-29
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-25
DMF Number : 23664
Submission : 2010-03-30
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-27
Pay. Date : 2013-02-06
DMF Number : 21125
Submission : 2007-12-14
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-27
Pay. Date : 2013-01-04
DMF Number : 19997
Submission : 2006-11-27
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-20
Pay. Date : 2020-01-28
DMF Number : 34423
Submission : 2019-12-31
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25902
Submission : 2012-03-23
Status :
Type : II
12
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A Sortis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sortis, including repackagers and relabelers. The FDA regulates Sortis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sortis 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 Sortis supplier is an individual or a company that provides Sortis active pharmaceutical ingredient (API) or Sortis finished formulations upon request. The Sortis suppliers may include Sortis API manufacturers, exporters, distributors and traders.
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A Sortis DMF (Drug Master File) is a document detailing the whole manufacturing process of Sortis active pharmaceutical ingredient (API) in detail. Different forms of Sortis DMFs exist exist since differing nations have different regulations, such as Sortis USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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