Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1TAPI Technology & API Services
03 2Amoli Organics
04 1Aurobindo Pharma Limited
05 1Azico Biophore India Pvt. Ltd
06 1Cadila Pharmaceuticals
07 1Hetero Drugs
08 1MSN Laboratories
09 1Macleods Pharmaceuticals Limited
10 1Par Pharmaceutical
11 1Raks Pharma
12 2SMS Pharmaceuticals
13 1Sichuan Kelun Pharmaceutical
14 1Signa S.A. de C.V.
15 1Sms Lifesciences
16 1Torrent Pharmaceuticals Limited
17 2Viatris
01 1SILDENAFIL
02 7SILDENAFIL CITRATE
03 1SILDENAFIL CITRATE (NON-STERILE BULK DRUG SUBSTANCE)
04 1SILDENAFIL CITRATE (UNIT-II)
05 1SILDENAFIL CITRATE FORM-II
06 6SILDENAFIL CITRATE USP
07 1SILDENAFIL CITRATE USP (NON-STERILE DRUG SUBSTANCE)
08 1SILDENAFIL CITRATE USP [ROUTE CODE - "SE"]
09 1Sildenafil Citrate
01 1China
02 13India
03 1Israel
04 1Mexico
05 1Poland
06 3U.S.A
01 16Active
02 4Inactive
01 11Complete
02 9Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-11
Pay. Date : 2016-06-13
DMF Number : 23930
Submission : 2010-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-29
Pay. Date : 2017-12-11
DMF Number : 17778
Submission : 2004-10-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2013-04-09
DMF Number : 21154
Submission : 2007-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-25
Pay. Date : 2013-11-18
DMF Number : 21619
Submission : 2008-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23705
Submission : 2010-04-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-02
Pay. Date : 2015-04-07
DMF Number : 24307
Submission : 2010-10-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23067
Submission : 2009-08-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-04
Pay. Date : 2017-07-07
DMF Number : 23509
Submission : 2010-02-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22142
Submission : 2008-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19097
Submission : 2006-01-10
Status : Active
Type : II
A Sildenafil Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sildenafil Citrate, including repackagers and relabelers. The FDA regulates Sildenafil Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sildenafil Citrate 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 Sildenafil Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sildenafil Citrate supplier is an individual or a company that provides Sildenafil Citrate active pharmaceutical ingredient (API) or Sildenafil Citrate finished formulations upon request. The Sildenafil Citrate suppliers may include Sildenafil Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sildenafil Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sildenafil Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sildenafil Citrate active pharmaceutical ingredient (API) in detail. Different forms of Sildenafil Citrate DMFs exist exist since differing nations have different regulations, such as Sildenafil Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sildenafil Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sildenafil Citrate USDMF includes data on Sildenafil Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sildenafil Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sildenafil Citrate suppliers with USDMF on PharmaCompass.
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