01 1INTERNATIONAL SPECIALTY PRODUCTS
01 1ALLANTOIN
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15310
Submission : 2001-02-21
Status : Active
Type : II
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PharmaCompass offers a list of Glyoxyldiureide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Glyoxyldiureide manufacturer or Glyoxyldiureide supplier for your needs.
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A (+/-)-Allantoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+/-)-Allantoin, including repackagers and relabelers. The FDA regulates (+/-)-Allantoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+/-)-Allantoin 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 (+/-)-Allantoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A (+/-)-Allantoin supplier is an individual or a company that provides (+/-)-Allantoin active pharmaceutical ingredient (API) or (+/-)-Allantoin finished formulations upon request. The (+/-)-Allantoin suppliers may include (+/-)-Allantoin API manufacturers, exporters, distributors and traders.
click here to find a list of (+/-)-Allantoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A (+/-)-Allantoin DMF (Drug Master File) is a document detailing the whole manufacturing process of (+/-)-Allantoin active pharmaceutical ingredient (API) in detail. Different forms of (+/-)-Allantoin DMFs exist exist since differing nations have different regulations, such as (+/-)-Allantoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (+/-)-Allantoin DMF submitted to regulatory agencies in the US is known as a USDMF. (+/-)-Allantoin USDMF includes data on (+/-)-Allantoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (+/-)-Allantoin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (+/-)-Allantoin suppliers with USDMF on PharmaCompass.
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