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 1Metrochem API Private Limited
04 1Cohance Lifesciences
05 1Ami Lifesciences Private Limited
06 1ALP Pharm
07 1Biocon
08 1Emnar Pharma
09 1Fuxin Long Rui Pharmaceutical
10 1HONOUR LAB LTD
11 1Hikal
12 1Lee Pharma
13 1MSN Laboratories
14 1Morepen Laboratories
15 1Piramal Pharma Solutions
16 2Zhejiang Huahai Pharmaceutical
01 1DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)
02 3DAPAGLIFLOZIN PROPANEDIOL
03 1DAPAGLIFLOZIN PROPANEDIOL (MONOHYDRATE) USP [ROUTE CODE - "DQ"]
04 1DAPAGLIFLOZIN PROPANEDIOL (PROCESS II) USP
05 9DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
06 1DAPAGLIFLOZIN PROPENEDIOL MONOHYDRATE
07 1Dapagliflozin Propanediol Monohydrate
01 4China
02 11India
03 1Poland
04 1U.S.A
01 17Active
01 6Complete
02 11Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-16
Pay. Date : 2018-12-20
DMF Number : 33387
Submission : 2018-12-30
Status : Active
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 : 33026
Submission : 2018-08-14
Status : Active
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 : 36048
Submission : 2021-06-28
Status : Active
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 : 34235
Submission : 2019-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38010
Submission : 2023-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27838
Submission : 2015-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32571
Submission : 2018-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-21
Pay. Date : 2018-10-30
DMF Number : 32972
Submission : 2018-11-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-07
Pay. Date : 2017-05-11
DMF Number : 28086
Submission : 2014-03-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2016-12-27
DMF Number : 31270
Submission : 2017-01-09
Status : Active
Type : II
A Dapagliflozin Propanediol Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapagliflozin Propanediol Monohydrate, including repackagers and relabelers. The FDA regulates Dapagliflozin Propanediol Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapagliflozin Propanediol Monohydrate 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 Dapagliflozin Propanediol Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dapagliflozin Propanediol Monohydrate supplier is an individual or a company that provides Dapagliflozin Propanediol Monohydrate active pharmaceutical ingredient (API) or Dapagliflozin Propanediol Monohydrate finished formulations upon request. The Dapagliflozin Propanediol Monohydrate suppliers may include Dapagliflozin Propanediol Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Dapagliflozin Propanediol Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dapagliflozin Propanediol Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dapagliflozin Propanediol Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Dapagliflozin Propanediol Monohydrate DMFs exist exist since differing nations have different regulations, such as Dapagliflozin Propanediol Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dapagliflozin Propanediol Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Dapagliflozin Propanediol Monohydrate USDMF includes data on Dapagliflozin Propanediol Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dapagliflozin Propanediol Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dapagliflozin Propanediol Monohydrate suppliers with USDMF on PharmaCompass.
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