01 1Pfizer Inc
02 1Shandong Lukang Pharmaceutical Co., Ltd
01 1SPECTINOMYCIN HCL USP, NON-STERILE, BULK DRUG SUBSTANCE
02 1SPECTINOMYCIN HYDROCHLORIDE
01 1China
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13407
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25129
Submission : 2011-07-15
Status : Active
Type : II
A Spectinomycin hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spectinomycin hydrochloride, including repackagers and relabelers. The FDA regulates Spectinomycin hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spectinomycin hydrochloride 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 Spectinomycin hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Spectinomycin hydrochloride supplier is an individual or a company that provides Spectinomycin hydrochloride active pharmaceutical ingredient (API) or Spectinomycin hydrochloride finished formulations upon request. The Spectinomycin hydrochloride suppliers may include Spectinomycin hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Spectinomycin hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Spectinomycin hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Spectinomycin hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Spectinomycin hydrochloride DMFs exist exist since differing nations have different regulations, such as Spectinomycin hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spectinomycin hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Spectinomycin hydrochloride USDMF includes data on Spectinomycin hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spectinomycin hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Spectinomycin hydrochloride suppliers with USDMF on PharmaCompass.
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