01 1Zhejiang Apeloa Jiayuan Pharmaceutical
01 1LEVALBUTEROL L-TARTRATE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24548
Submission : 2011-01-04
Status : Active
Type : II
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A XOPENEX HFA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of XOPENEX HFA, including repackagers and relabelers. The FDA regulates XOPENEX HFA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. XOPENEX HFA 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 XOPENEX HFA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A XOPENEX HFA supplier is an individual or a company that provides XOPENEX HFA active pharmaceutical ingredient (API) or XOPENEX HFA finished formulations upon request. The XOPENEX HFA suppliers may include XOPENEX HFA API manufacturers, exporters, distributors and traders.
click here to find a list of XOPENEX HFA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A XOPENEX HFA DMF (Drug Master File) is a document detailing the whole manufacturing process of XOPENEX HFA active pharmaceutical ingredient (API) in detail. Different forms of XOPENEX HFA DMFs exist exist since differing nations have different regulations, such as XOPENEX HFA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A XOPENEX HFA DMF submitted to regulatory agencies in the US is known as a USDMF. XOPENEX HFA USDMF includes data on XOPENEX HFA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The XOPENEX HFA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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