01 1Formosa Laboratories
02 1Solara Active Pharma Sciences
01 2PATIROMER SORBITEX CALCIUM
01 1India
02 1Taiwan
01 2Active
01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-16
Pay. Date : 2019-07-25
DMF Number : 32966
Submission : 2019-06-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-15
Pay. Date : 2019-04-23
DMF Number : 33634
Submission : 2019-03-29
Status : Active
Type : II
A Patiromer Sorbitex Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Patiromer Sorbitex Calcium, including repackagers and relabelers. The FDA regulates Patiromer Sorbitex Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Patiromer Sorbitex Calcium supplier is an individual or a company that provides Patiromer Sorbitex Calcium active pharmaceutical ingredient (API) or Patiromer Sorbitex Calcium finished formulations upon request. The Patiromer Sorbitex Calcium suppliers may include Patiromer Sorbitex Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Patiromer Sorbitex Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Patiromer Sorbitex Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Patiromer Sorbitex Calcium active pharmaceutical ingredient (API) in detail. Different forms of Patiromer Sorbitex Calcium DMFs exist exist since differing nations have different regulations, such as Patiromer Sorbitex Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Patiromer Sorbitex Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Patiromer Sorbitex Calcium USDMF includes data on Patiromer Sorbitex Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Patiromer Sorbitex Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Patiromer Sorbitex Calcium suppliers with USDMF on PharmaCompass.
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