Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Dr. Reddy's Laboratories
03 1Cohance Lifesciences
04 1Ami Lifesciences Private Limited
05 1Medichem S.A
06 1Neuland Laboratories
07 1USV Private Limited
08 1TAPI Technology & API Services
09 1Alembic Pharmaceuticals Limited
10 1Amoli Organics
11 1Apotex Pharmachem
12 1Aurobindo Pharma Limited
13 2Bayer AG
14 1Biocon
15 1Changzhou Pharmaceutical Factory
16 1Charioteer
17 1Chengda Pharmaceuticals
18 1Cipla
19 1Fuxin Long Rui Pharmaceutical
20 1Glenmark Life Sciences
21 1HEC Pharm
22 1Hetero Drugs
23 1Hikal
24 1Indoco Remedies Limited
25 1Innovare Labs
26 1Intas Pharmaceuticals
27 1Jiangxi Synergy Pharmaceutical
28 1Johnson & Johnson Innovative Medicine
29 1Jubilant Generics
30 1Lee Pharma
31 1Lupin Ltd
32 1MSN Laboratories
33 1Macleods Pharmaceuticals Limited
34 1Megafine Pharma (P) Limited
35 1Micro Labs Limited
36 1Morepen Laboratories
37 1Optimus Pharma
38 1Piramal Pharma Solutions
39 1Quimica Sintetica
40 1Raks Pharma
41 1SMS Pharmaceuticals
42 1Srini Pharmaceuticals
43 1Symed Labs
44 1TOPHARMAN SHANDONG CO LTD
45 1Taro Pharmaceutical Industries
46 1Tianjin Weijie Pharmaceutical Co., Ltd.
47 1UQUIFA
48 1Unichem Laboratories Limited
49 1Vasudha Pharma Chem
50 1Viatris
51 1Viwit Pharmaceuticals Limited
52 1YUNG ZIP CHEMICAL INDUSTRIAL
53 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
54 1Zhejiang Guobang Pharmaceutical
55 1Zhejiang Huahai Pharmaceutical
56 1Zhejiang Jingxin Pharmaceutical Co. ltd
57 1Zhejiang Supor Pharmaceuticals Co., LTD
58 1Zhejiang Tianyu Pharmaceutical Co., Ltd
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-11-21
DMF Number : 27661
Submission : 2013-10-21
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-29
Pay. Date : 2014-05-12
DMF Number : 28121
Submission : 2014-03-31
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32115
Submission : 2017-10-02
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37173
Submission : 2022-06-06
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-15
Pay. Date : 2014-12-23
DMF Number : 28916
Submission : 2014-12-23
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-13
Pay. Date : 2022-04-27
DMF Number : 30609
Submission : 2016-09-28
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-17
Pay. Date : 2023-03-27
DMF Number : 38119
Submission : 2023-03-31
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 : 2018-03-21
Pay. Date : 2014-12-08
DMF Number : 28819
Submission : 2017-11-30
Status :
Type : II
A Xarelto manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xarelto, including repackagers and relabelers. The FDA regulates Xarelto manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xarelto 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 Xarelto manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xarelto supplier is an individual or a company that provides Xarelto active pharmaceutical ingredient (API) or Xarelto finished formulations upon request. The Xarelto suppliers may include Xarelto API manufacturers, exporters, distributors and traders.
click here to find a list of Xarelto suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Xarelto DMF (Drug Master File) is a document detailing the whole manufacturing process of Xarelto active pharmaceutical ingredient (API) in detail. Different forms of Xarelto DMFs exist exist since differing nations have different regulations, such as Xarelto USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xarelto DMF submitted to regulatory agencies in the US is known as a USDMF. Xarelto USDMF includes data on Xarelto's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xarelto USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xarelto suppliers with USDMF on PharmaCompass.
We have 58 companies offering Xarelto
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