01 1Lunan Pharmaceutical
02 1Sumitomo Chemical
03 1Blank
01 1OTERACIL POTASSIUM
02 1OXONIC ACID POTASSIUM SALT
03 1POTASSIUM OTASTAT
01 1China
02 1Japan
03 1Blank
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35057
Submission : 2021-01-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13908
Submission : 1998-12-22
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12568
Submission : 1997-06-30
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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PharmaCompass offers a list of Oteracil Potassium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Oteracil Potassium manufacturer or Oteracil Potassium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oteracil Potassium manufacturer or Oteracil Potassium supplier.
PharmaCompass also assists you with knowing the Oteracil Potassium API Price utilized in the formulation of products. Oteracil Potassium API Price is not always fixed or binding as the Oteracil Potassium Price is obtained through a variety of data sources. The Oteracil Potassium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A O0164 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of O0164, including repackagers and relabelers. The FDA regulates O0164 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. O0164 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 O0164 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A O0164 supplier is an individual or a company that provides O0164 active pharmaceutical ingredient (API) or O0164 finished formulations upon request. The O0164 suppliers may include O0164 API manufacturers, exporters, distributors and traders.
click here to find a list of O0164 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A O0164 DMF (Drug Master File) is a document detailing the whole manufacturing process of O0164 active pharmaceutical ingredient (API) in detail. Different forms of O0164 DMFs exist exist since differing nations have different regulations, such as O0164 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A O0164 DMF submitted to regulatory agencies in the US is known as a USDMF. O0164 USDMF includes data on O0164's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The O0164 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of O0164 suppliers with USDMF on PharmaCompass.
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