Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
02 1Cambrex Corporation
03 1Cipla
04 3Daiichi Sankyo
05 1KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTD
06 1Mahima Life Sciences
07 1Quimica Sintetica
08 1RANBAXY LABORATORIES LIMITED
09 1Turtle Pharma
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-26
Pay. Date : 2015-10-15
DMF Number : 15433
Submission : 2001-05-15
Status :
Type : II
A Ofloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ofloxacin, including repackagers and relabelers. The FDA regulates Ofloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ofloxacin 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 Ofloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ofloxacin supplier is an individual or a company that provides Ofloxacin active pharmaceutical ingredient (API) or Ofloxacin finished formulations upon request. The Ofloxacin suppliers may include Ofloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Ofloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ofloxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Ofloxacin active pharmaceutical ingredient (API) in detail. Different forms of Ofloxacin DMFs exist exist since differing nations have different regulations, such as Ofloxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ofloxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Ofloxacin USDMF includes data on Ofloxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ofloxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ofloxacin suppliers with USDMF on PharmaCompass.
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