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01 1Dishman Carbogen Amcis
02 1Edmond Pharma
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01 1LEVOBUPIVACAINE
02 1LEVOBUPIVACAINE HYDROCHLORIDE
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01 2India
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01 1Active
02 1Inactive
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01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33982
Submission : 2019-08-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38858
Submission : 2023-09-26
Status : Active
Type : II
A Levobupivacaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levobupivacaine, including repackagers and relabelers. The FDA regulates Levobupivacaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levobupivacaine 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 Levobupivacaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levobupivacaine supplier is an individual or a company that provides Levobupivacaine active pharmaceutical ingredient (API) or Levobupivacaine finished formulations upon request. The Levobupivacaine suppliers may include Levobupivacaine API manufacturers, exporters, distributors and traders.
click here to find a list of Levobupivacaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levobupivacaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Levobupivacaine active pharmaceutical ingredient (API) in detail. Different forms of Levobupivacaine DMFs exist exist since differing nations have different regulations, such as Levobupivacaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levobupivacaine DMF submitted to regulatory agencies in the US is known as a USDMF. Levobupivacaine USDMF includes data on Levobupivacaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levobupivacaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levobupivacaine suppliers with USDMF on PharmaCompass.
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