01 1ROHNER LTD
01 14-AMINO-5-CHLORO2,1,3-BENZOTHIADIAZOLE (CABTD)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14236
Submission : 1999-06-07
Status : Active
Type : II
15
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A Tizanidine related compound A [USP] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tizanidine related compound A [USP], including repackagers and relabelers. The FDA regulates Tizanidine related compound A [USP] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tizanidine related compound A [USP] 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 Tizanidine related compound A [USP] supplier is an individual or a company that provides Tizanidine related compound A [USP] active pharmaceutical ingredient (API) or Tizanidine related compound A [USP] finished formulations upon request. The Tizanidine related compound A [USP] suppliers may include Tizanidine related compound A [USP] API manufacturers, exporters, distributors and traders.
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A Tizanidine related compound A [USP] DMF (Drug Master File) is a document detailing the whole manufacturing process of Tizanidine related compound A [USP] active pharmaceutical ingredient (API) in detail. Different forms of Tizanidine related compound A [USP] DMFs exist exist since differing nations have different regulations, such as Tizanidine related compound A [USP] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tizanidine related compound A [USP] DMF submitted to regulatory agencies in the US is known as a USDMF. Tizanidine related compound A [USP] USDMF includes data on Tizanidine related compound A [USP]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tizanidine related compound A [USP] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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