ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1TAPI Technology & API Services
03 1Apotex Pharmachem
04 2Cipla
05 1Fresenius Kabi AB Brunna
06 1Gador SA
07 1Hospira, Inc.
08 1Sun Pharmaceutical Industries Limited
01 1DISODIUM PAMIDRONATE
02 2DISODIUM PAMIDRONATE USP
03 1PAMIDRONATE BULK CHEMICAL
04 4PAMIDRONIC ACID
05 1PAMIDRONIC ACID DRUG SUBSTANCE
01 1Argentina
02 1Canada
03 3India
04 1Israel
05 1Sweden
06 2U.S.A
01 2Active
02 7Inactive
01 1Complete
02 8Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-11-19
DMF Number : 12803
Submission : 1997-12-22
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 : 13946
Submission : 1999-01-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19901
Submission : 2006-10-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17842
Submission : 2004-11-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14686
Submission : 2000-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18532
Submission : 2005-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14504
Submission : 1999-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19573
Submission : 2006-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18280
Submission : 2005-04-18
Status : Inactive
Type : II
A Pamidronate Disodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pamidronate Disodium , including repackagers and relabelers. The FDA regulates Pamidronate Disodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pamidronate Disodium 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 Pamidronate Disodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pamidronate Disodium supplier is an individual or a company that provides Pamidronate Disodium active pharmaceutical ingredient (API) or Pamidronate Disodium finished formulations upon request. The Pamidronate Disodium suppliers may include Pamidronate Disodium API manufacturers, exporters, distributors and traders.
click here to find a list of Pamidronate Disodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pamidronate Disodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pamidronate Disodium active pharmaceutical ingredient (API) in detail. Different forms of Pamidronate Disodium DMFs exist exist since differing nations have different regulations, such as Pamidronate Disodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pamidronate Disodium DMF submitted to regulatory agencies in the US is known as a USDMF. Pamidronate Disodium USDMF includes data on Pamidronate Disodium 's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pamidronate Disodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pamidronate Disodium suppliers with USDMF on PharmaCompass.
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