01 1Piramal Pharma Solutions
02 1Sifavitor srl
03 1Sumitomo Chemical
04 2Blank
01 4LEVOBUNOLOL HYDROCHLORIDE
02 1LEVOBUNOLOL HYDROCHLORIDE (1-BUNOLOL HYDROCHLORIDE)
01 1Italy
02 1Japan
03 1U.S.A
04 2Blank
01 2Active
02 3Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16904
Submission : 2003-10-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14195
Submission : 1999-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9652
Submission : 1992-05-11
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11519
Submission : 1995-05-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5113
Submission : 1983-09-15
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Levobunolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levobunolol, including repackagers and relabelers. The FDA regulates Levobunolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levobunolol 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 Levobunolol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levobunolol supplier is an individual or a company that provides Levobunolol active pharmaceutical ingredient (API) or Levobunolol finished formulations upon request. The Levobunolol suppliers may include Levobunolol API manufacturers, exporters, distributors and traders.
click here to find a list of Levobunolol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levobunolol DMF (Drug Master File) is a document detailing the whole manufacturing process of Levobunolol active pharmaceutical ingredient (API) in detail. Different forms of Levobunolol DMFs exist exist since differing nations have different regulations, such as Levobunolol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levobunolol DMF submitted to regulatory agencies in the US is known as a USDMF. Levobunolol USDMF includes data on Levobunolol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levobunolol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levobunolol suppliers with USDMF on PharmaCompass.
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