Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Cohance Lifesciences
03 1Dr. Reddy's Laboratories
04 1Neuland Laboratories
05 1USV Private Limited
06 1TAPI Technology & API Services
07 1Alembic Pharmaceuticals Limited
08 1CTX Lifesciences
09 2Changzhou Pharmaceutical Factory
10 1Divis Laboratories
11 1HEC Pharm
12 1HONOUR LAB LTD
13 1Innovare Labs
14 1Jiangxi Synergy Pharmaceutical
15 1Jubilant Generics
16 1Kaiyuan Hengtai Pharma Co., Ltd.
17 1Lek Pharmaceuticals
18 2MSN Laboratories
19 1Macleods Pharmaceuticals Limited
20 1Mankind Pharma
21 1Micro Labs Limited
22 1Morepen Laboratories
23 1PharmaResources
24 1Raks Pharma
25 1Shanghai Huilun Pharmaceutical
26 1Sichuan Qingmu Pharmaceutical
27 1Taro Pharmaceutical Industries
28 1Unichem Laboratories Limited
29 1Viatris
30 1Viyash Life Sciences
31 1WUHAN ZY PHARMACEUTICAL CO LTD
32 1Zhejiang Hisun Pharmaceutical
33 1Zhejiang Jingxin Pharmaceutical Co. ltd
34 1Zhejiang Supor Pharmaceuticals Co., LTD
35 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 : 2015-02-23
Pay. Date : 2014-11-21
DMF Number : 28674
Submission : 2014-09-24
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 : 34420
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 : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-08-07
DMF Number : 28446
Submission : 2014-08-28
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33748
Submission : 2019-04-19
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-09
Pay. Date : 2021-03-24
DMF Number : 35767
Submission : 2021-09-24
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 : 2015-03-17
Pay. Date : 2014-12-09
DMF Number : 28880
Submission : 2015-01-21
Status :
Type : II
A Brilinta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brilinta, including repackagers and relabelers. The FDA regulates Brilinta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brilinta 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 Brilinta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brilinta supplier is an individual or a company that provides Brilinta active pharmaceutical ingredient (API) or Brilinta finished formulations upon request. The Brilinta suppliers may include Brilinta API manufacturers, exporters, distributors and traders.
click here to find a list of Brilinta suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Brilinta DMF (Drug Master File) is a document detailing the whole manufacturing process of Brilinta active pharmaceutical ingredient (API) in detail. Different forms of Brilinta DMFs exist exist since differing nations have different regulations, such as Brilinta USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brilinta DMF submitted to regulatory agencies in the US is known as a USDMF. Brilinta USDMF includes data on Brilinta's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brilinta USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brilinta suppliers with USDMF on PharmaCompass.
We have 35 companies offering Brilinta
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