Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
01 1Metrochem API Private Limited
02 2Lee Pharma
01 2TEGOPRAZAN
02 1TEGOPRAZAN CRYSTALLINE
01 3India
01 3Active
01 3Blank
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38991
Submission : 2023-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39217
Submission : 2023-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39156
Submission : 2023-11-18
Status : Active
Type : II
A Tegoprazan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tegoprazan, including repackagers and relabelers. The FDA regulates Tegoprazan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tegoprazan 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 Tegoprazan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tegoprazan supplier is an individual or a company that provides Tegoprazan active pharmaceutical ingredient (API) or Tegoprazan finished formulations upon request. The Tegoprazan suppliers may include Tegoprazan API manufacturers, exporters, distributors and traders.
click here to find a list of Tegoprazan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tegoprazan DMF (Drug Master File) is a document detailing the whole manufacturing process of Tegoprazan active pharmaceutical ingredient (API) in detail. Different forms of Tegoprazan DMFs exist exist since differing nations have different regulations, such as Tegoprazan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tegoprazan DMF submitted to regulatory agencies in the US is known as a USDMF. Tegoprazan USDMF includes data on Tegoprazan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tegoprazan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tegoprazan suppliers with USDMF on PharmaCompass.
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