01 2Bayer AG
02 1Zhejiang Apeloa Tospo Pharmaceutical Co., Ltd.
01 1Pradofloxacin
02 1Pradofloxacin Anhydrate
03 1Pradofloxacin Trihydrate
01 1China
02 2Germany
NDC Package Code : 12527-0385
Start Marketing Date : 2021-08-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12527-0386
Start Marketing Date : 2021-08-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66653-011
Start Marketing Date : 2024-04-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Pradofloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pradofloxacin, including repackagers and relabelers. The FDA regulates Pradofloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pradofloxacin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Pradofloxacin supplier is an individual or a company that provides Pradofloxacin active pharmaceutical ingredient (API) or Pradofloxacin finished formulations upon request. The Pradofloxacin suppliers may include Pradofloxacin API manufacturers, exporters, distributors and traders.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pradofloxacin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pradofloxacin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Pradofloxacin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Pradofloxacin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pradofloxacin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pradofloxacin suppliers with NDC on PharmaCompass.
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