DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1MSN Laboratories
03 1Shanghai Wonder Pharmaceutical
04 1Turtle Pharma
01 1LEVOFLOXACIN HEMIHYDATE
02 3LEVOFLOXACIN HEMIHYDRATE USP
01 1China
02 3India
01 4Active
01 1Complete
02 3Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-14
Pay. Date : 2020-08-10
DMF Number : 16658
Submission : 2003-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32663
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39212
Submission : 2023-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33244
Submission : 2018-10-16
Status : Active
Type : II
A Levofloxacin Hemihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levofloxacin Hemihydrate, including repackagers and relabelers. The FDA regulates Levofloxacin Hemihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levofloxacin Hemihydrate 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 Levofloxacin Hemihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levofloxacin Hemihydrate supplier is an individual or a company that provides Levofloxacin Hemihydrate active pharmaceutical ingredient (API) or Levofloxacin Hemihydrate finished formulations upon request. The Levofloxacin Hemihydrate suppliers may include Levofloxacin Hemihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Levofloxacin Hemihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levofloxacin Hemihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Levofloxacin Hemihydrate active pharmaceutical ingredient (API) in detail. Different forms of Levofloxacin Hemihydrate DMFs exist exist since differing nations have different regulations, such as Levofloxacin Hemihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levofloxacin Hemihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Levofloxacin Hemihydrate USDMF includes data on Levofloxacin Hemihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levofloxacin Hemihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levofloxacin Hemihydrate suppliers with USDMF on PharmaCompass.
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