01 1HyClone Laboratories Inc.
01 1HYCLONE CCM MEDIA PRODUCTS
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18626
Submission : 1994-02-01
Status : Active
Type : II
A Hyq manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyq, including repackagers and relabelers. The FDA regulates Hyq manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyq 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 Hyq supplier is an individual or a company that provides Hyq active pharmaceutical ingredient (API) or Hyq finished formulations upon request. The Hyq suppliers may include Hyq API manufacturers, exporters, distributors and traders.
click here to find a list of Hyq suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyq DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyq active pharmaceutical ingredient (API) in detail. Different forms of Hyq DMFs exist exist since differing nations have different regulations, such as Hyq USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyq DMF submitted to regulatory agencies in the US is known as a USDMF. Hyq USDMF includes data on Hyq's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyq USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyq suppliers with USDMF on PharmaCompass.
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