A Water for injection, sterile manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Water for injection, sterile, including repackagers and relabelers. The FDA regulates Water for injection, sterile manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Water for injection, sterile 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 Water for injection, sterile manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.