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 1Alchymars ICM SM
04 1Apotex Pharmachem
05 1Aurobindo Pharma Limited
06 1Cipla
07 1Divis Laboratories
08 1Hetero Drugs
09 1ITF CHEMICAL LTDA
10 1Ind Swift Laboratories Limited
11 2Ipca Laboratories
12 1Jubilant Generics
13 1Macleods Pharmaceuticals Limited
14 1Orchid Pharma
15 1Sun Pharmaceutical Industries Limited
16 1Viatris
01 4RISEDRONATE SODIUM
02 1RISEDRONATE SODIUM HEMI PENTAHYDRATE USP
03 3RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP
04 1RISEDRONATE SODIUM HEMI-PENTAHYDRATE, USP
05 1RISEDRONATE SODIUM HEMIPENTAHYDRATE USAP (NON-STERILE DRUG SUBSTANCE)
06 2RISEDRONATE SODIUM HEMIPENTAHYDRATE USP
07 1RISEDRONATE SODIUM HEMIPENTAHYDRATE-USP
08 1RISEDRONATE SODIUM USP
09 1RISEDRONATE SODIUM USP (HEMI-PENTAHYDRATE)
10 1SODIUM RISEDRONATE AMORPHOUS
11 1SODIUM RISEDRONATE HEMI-PENTAHYDRATE
01 1Brazil
02 1Canada
03 12India
04 1Israel
05 1Poland
06 1U.S.A
01 14Active
02 3Inactive
01 5Complete
02 12Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-13
Pay. Date : 2012-12-11
DMF Number : 20384
Submission : 2007-03-26
Status : Active
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 16604
Submission : 2003-05-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-16
Pay. Date : 2014-10-14
DMF Number : 21819
Submission : 2008-07-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-18
DMF Number : 21121
Submission : 2007-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20162
Submission : 2007-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21033
Submission : 2007-10-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19968
Submission : 2006-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23738
Submission : 2010-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21529
Submission : 2008-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20398
Submission : 2007-04-02
Status : Active
Type : II
A Risedronate (sodium) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Risedronate (sodium), including repackagers and relabelers. The FDA regulates Risedronate (sodium) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Risedronate (sodium) 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 Risedronate (sodium) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Risedronate (sodium) supplier is an individual or a company that provides Risedronate (sodium) active pharmaceutical ingredient (API) or Risedronate (sodium) finished formulations upon request. The Risedronate (sodium) suppliers may include Risedronate (sodium) API manufacturers, exporters, distributors and traders.
click here to find a list of Risedronate (sodium) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Risedronate (sodium) DMF (Drug Master File) is a document detailing the whole manufacturing process of Risedronate (sodium) active pharmaceutical ingredient (API) in detail. Different forms of Risedronate (sodium) DMFs exist exist since differing nations have different regulations, such as Risedronate (sodium) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Risedronate (sodium) DMF submitted to regulatory agencies in the US is known as a USDMF. Risedronate (sodium) USDMF includes data on Risedronate (sodium)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Risedronate (sodium) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Risedronate (sodium) suppliers with USDMF on PharmaCompass.
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