01 1Formosa Laboratories
01 1DDAIP.HCI
01 1Taiwan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19586
Submission : 2006-07-11
Status : Active
Type : II
A Nexact-88 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexact-88, including repackagers and relabelers. The FDA regulates Nexact-88 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexact-88 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Nexact-88 supplier is an individual or a company that provides Nexact-88 active pharmaceutical ingredient (API) or Nexact-88 finished formulations upon request. The Nexact-88 suppliers may include Nexact-88 API manufacturers, exporters, distributors and traders.
click here to find a list of Nexact-88 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nexact-88 DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexact-88 active pharmaceutical ingredient (API) in detail. Different forms of Nexact-88 DMFs exist exist since differing nations have different regulations, such as Nexact-88 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nexact-88 DMF submitted to regulatory agencies in the US is known as a USDMF. Nexact-88 USDMF includes data on Nexact-88's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexact-88 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nexact-88 suppliers with USDMF on PharmaCompass.
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