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 1Shandong Chenghui Shuangda Pharmaceutical
03 1Ami Lifesciences Private Limited
04 1Beijing THTD Pharmaceutical Tech
05 1Biocompounds Pharmaceutical Inc
06 1Jiangxi Synergy Pharmaceutical
07 1Lee Pharma
08 1MSN Laboratories
09 1Maithri Drugs
10 1Morepen Laboratories
11 1Optimus Pharma
12 1Viyash Life Sciences
13 1Zhejiang Guobang Pharmaceutical
14 1Zhejiang Jingsheng Pharmaceutical
01 14VONOPRAZAN FUMARATE
01 6China
02 8India
01 14Active
01 14Blank
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
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DMF Number : 35150
Submission : 2020-08-31
Status : Active
Type : II
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
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DMF Number : 39107
Submission : 2023-11-02
Status : Active
Type : II
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DMF Number : 36262
Submission : 2021-09-06
Status : Active
Type : II
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DMF Review : N/A
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DMF Number : 32831
Submission : 2018-06-26
Status : Active
Type : II
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DMF Review : N/A
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DMF Number : 39360
Submission : 2024-05-16
Status : Active
Type : II
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DMF Review : N/A
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DMF Number : 38701
Submission : 2023-09-02
Status : Active
Type : II
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DMF Number : 38293
Submission : 2023-04-17
Status : Active
Type : II
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DMF Review : N/A
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Pay. Date :
DMF Number : 37923
Submission : 2023-01-05
Status : Active
Type : II
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DMF Review : N/A
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DMF Number : 37045
Submission : 2022-04-28
Status : Active
Type : II
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DMF Number : 39476
Submission : 2024-01-26
Status : Active
Type : II
A Vonoprazan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan, including repackagers and relabelers. The FDA regulates Vonoprazan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan 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 Vonoprazan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vonoprazan supplier is an individual or a company that provides Vonoprazan active pharmaceutical ingredient (API) or Vonoprazan finished formulations upon request. The Vonoprazan suppliers may include Vonoprazan API manufacturers, exporters, distributors and traders.
click here to find a list of Vonoprazan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vonoprazan DMF (Drug Master File) is a document detailing the whole manufacturing process of Vonoprazan active pharmaceutical ingredient (API) in detail. Different forms of Vonoprazan DMFs exist exist since differing nations have different regulations, such as Vonoprazan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vonoprazan DMF submitted to regulatory agencies in the US is known as a USDMF. Vonoprazan USDMF includes data on Vonoprazan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vonoprazan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vonoprazan suppliers with USDMF on PharmaCompass.
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