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 1Minakem (formerly Delmar Chemicals)
04 1Metrochem API Private Limited
05 1Cohance Lifesciences
06 1Aarti Pharmalabs
07 1Medichem S.A
08 2Neuland Laboratories
09 1ALP Pharm
10 1Actavis Inc
11 1Alembic Pharmaceuticals Limited
12 1Amoli Organics
13 1Apotex Pharmachem
14 1Aurobindo Pharma Limited
15 1Biocon
16 1Changzhou Pharmaceutical Factory
17 1Glenmark Life Sciences
18 1HEC Pharm
19 1HONOUR LAB LTD
20 1Hikal
21 1Indoco Remedies Limited
22 1Jiangxi Synergy Pharmaceutical
23 1Jubilant Generics
24 1Lee Pharma
25 2MSN Laboratories
26 1Macleods Pharmaceuticals Limited
27 1Micro Labs Limited
28 3Morepen Laboratories
29 1Natco Pharma
30 1Ningbo Menovo Pharmaceutical
31 1Optimus Pharma
32 1SINTENOVO, S.A. DE C.V.
33 1SMS Pharmaceuticals
34 2ScinoPharm Taiwan, Ltd
35 1Sichuan Qingmu Pharmaceutical
36 1Sigmapharm Laboratories, LLC
37 2Srini Pharmaceuticals
38 1Sun Pharmaceutical Industries Limited
39 1Teva Pharmaceutical Industries
40 1Unichem Laboratories Limited
41 1Viatris
42 1Viyash Life Sciences
43 1Zhejiang Guobang Pharmaceutical
44 1Zhejiang Hisun Pharmaceutical
45 1Zhejiang Huahai Pharmaceutical
46 1Zhejiang Supor Pharmaceuticals Co., LTD
47 1Zhejiang Tianyu Pharmaceutical Co., Ltd
48 1Zydus Lifesciences
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-10
Pay. Date : 2016-12-20
DMF Number : 31166
Submission : 2016-11-16
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-11
Pay. Date : 2015-09-30
DMF Number : 29707
Submission : 2015-09-22
Status :
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-15
Pay. Date : 2016-03-28
DMF Number : 30336
Submission : 2016-03-14
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35518
Submission : 2020-12-30
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 : 34988
Submission : 2020-07-02
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35969
Submission : 2021-07-01
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-20
Pay. Date : 2016-06-30
DMF Number : 30646
Submission : 2016-06-30
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-16
Pay. Date : 2018-06-13
DMF Number : 32422
Submission : 2018-01-31
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39444
Submission : 2024-01-31
Status :
Type : II
A Apixaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apixaban, including repackagers and relabelers. The FDA regulates Apixaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apixaban 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 Apixaban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apixaban supplier is an individual or a company that provides Apixaban active pharmaceutical ingredient (API) or Apixaban finished formulations upon request. The Apixaban suppliers may include Apixaban API manufacturers, exporters, distributors and traders.
click here to find a list of Apixaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apixaban DMF (Drug Master File) is a document detailing the whole manufacturing process of Apixaban active pharmaceutical ingredient (API) in detail. Different forms of Apixaban DMFs exist exist since differing nations have different regulations, such as Apixaban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apixaban DMF submitted to regulatory agencies in the US is known as a USDMF. Apixaban USDMF includes data on Apixaban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apixaban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Apixaban suppliers with USDMF on PharmaCompass.
We have 48 companies offering Apixaban
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