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 1Alembic Pharmaceuticals Limited
04 1Apotex Inc
05 1Aurobindo Pharma Limited
06 1CSPC Pharmaceutical Group
07 1CTX Lifesciences
08 1Cadila Pharmaceuticals
09 2Chemi SpA
10 1Chongqing Carelife Pharmaceutical
11 1Cipla
12 1Gador SA
13 1Ipca Laboratories
14 1Jubilant Generics
15 1Lupin Ltd
16 1Minsheng Group Shaoxing Pharmaceutical
17 1Orchid Pharma
18 1Signa S.A. de C.V.
19 1Sun Pharmaceutical Industries Limited
20 1Teva Pharmaceutical Industries
21 1Trifarma
22 1Viatris
23 1Blank
01 1ALEDRONATE SODIUM USP
02 1ALENDRONATE MONOSODIUM TRIHYDRATE
03 2ALENDRONATE SODIUM
04 1ALENDRONATE SODIUM NON-STERILE BULK DRUG SUBSTANCE
05 1ALENDRONATE SODIUM TRIHYDRATE
06 2ALENDRONATE SODIUM TRIHYDRATE USP
07 7ALENDRONATE SODIUM USP
08 1ALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE)
09 1ALENDRONATE SODIUM USP (TRIHYDRATE)
10 1ALENDRONATE SODIUM USP 28
11 4SODIUM ALENDRONATE
12 2SODIUM ALENDRONATE TRIHYDRATE
01 1Argentina
02 1Canada
03 3China
04 10India
05 2Israel
06 3Italy
07 1Mexico
08 1Poland
09 1U.S.A
10 1Blank
01 12Active
02 12Inactive
01 4Complete
02 20Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 16962
Submission : 2003-11-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20443
Submission : 2007-04-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15409
Submission : 2001-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20031
Submission : 2006-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20704
Submission : 2007-07-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-15
Pay. Date : 2019-12-11
DMF Number : 14334
Submission : 1999-08-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20415
Submission : 2007-04-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20786
Submission : 2007-08-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18327
Submission : 2005-05-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20402
Submission : 2007-04-02
Status : Active
Type : II
A Fosamax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosamax, including repackagers and relabelers. The FDA regulates Fosamax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosamax 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 Fosamax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosamax supplier is an individual or a company that provides Fosamax active pharmaceutical ingredient (API) or Fosamax finished formulations upon request. The Fosamax suppliers may include Fosamax API manufacturers, exporters, distributors and traders.
click here to find a list of Fosamax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosamax DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosamax active pharmaceutical ingredient (API) in detail. Different forms of Fosamax DMFs exist exist since differing nations have different regulations, such as Fosamax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosamax DMF submitted to regulatory agencies in the US is known as a USDMF. Fosamax USDMF includes data on Fosamax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosamax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosamax suppliers with USDMF on PharmaCompass.
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