Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
01 2Metrochem API Private Limited
02 2Dr. Reddy's Laboratories
03 1Moehs Iberica
04 1Alembic Pharmaceuticals Limited
05 1Alkem Laboratories
06 1Amino Chemicals
07 1Aurobindo Pharma Limited
08 2CHEMO IBERICA SA
09 1Cadila Pharmaceuticals
10 1Cipla
11 1Hetero Drugs
12 1Jubilant Generics
13 1Lupin Ltd
14 1Macleods Pharmaceuticals Limited
15 1Nosch Labs Pvt
16 1Orchid Pharma
17 1RANBAXY LABORATORIES LIMITED
18 1Raks Pharma
19 1SINTENOVO, S.A. DE C.V.
20 1Shanghai Sine Pharmaceutical Laboratories Co.,Ltd.
21 1Sterile India Pvt. Ltd
22 1Sun Pharmaceutical Industries Limited
23 1Syn-Tech Chem. & Pharm
24 1Torrent Pharmaceuticals Limited
25 1UQUIFA
26 1Viatris
27 2Zydus Lifesciences
01 17RABEPRAZOLE SODIUM
02 1RABEPRAZOLE SODIUM (PROCESS I)
03 1RABEPRAZOLE SODIUM (PROCESS II)
04 1RABEPRAZOLE SODIUM (STERILE)
05 1RABEPRAZOLE SODIUM (Y-FORM)
06 1RABEPRAZOLE SODIUM HYDRATE (FORM Y) USP
07 1RABEPRAZOLE SODIUM HYDRATE (FORM-Y), USP
08 1RABEPRAZOLE SODIUM MONOHYDRATE
09 4RABEPRAZOLE SODIUM USP
10 1RABEPRAZOLE SODIUM-USP (HYDRATE, AMORPHOUS)
11 1Rabeprazole Sodium (Amorphous)
12 1Rabeprazole Sodium (Non-Sterile Bulk Drug Substance)
01 1China
02 22India
03 1Malta
04 1Mexico
05 4Spain
06 1Taiwan
07 1U.S.A
01 17Active
02 14Inactive
01 7Complete
02 24Blank
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-17
Pay. Date : 2023-07-17
DMF Number : 35344
Submission : 2020-11-27
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16747
Submission : 2003-08-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24924
Submission : 2011-05-02
Status : Active
Type : II
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 : 37630
Submission : 2022-11-14
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-09-03
DMF Number : 22031
Submission : 2008-10-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-21
Pay. Date : 2013-05-21
DMF Number : 19186
Submission : 2006-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-24
Pay. Date : 2014-03-20
DMF Number : 22338
Submission : 2009-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19903
Submission : 2006-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23400
Submission : 2009-12-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21736
Submission : 2008-06-26
Status : Active
Type : II
A Rabeprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rabeprazole, including repackagers and relabelers. The FDA regulates Rabeprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rabeprazole 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 Rabeprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rabeprazole supplier is an individual or a company that provides Rabeprazole active pharmaceutical ingredient (API) or Rabeprazole finished formulations upon request. The Rabeprazole suppliers may include Rabeprazole API manufacturers, exporters, distributors and traders.
click here to find a list of Rabeprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rabeprazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Rabeprazole active pharmaceutical ingredient (API) in detail. Different forms of Rabeprazole DMFs exist exist since differing nations have different regulations, such as Rabeprazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rabeprazole DMF submitted to regulatory agencies in the US is known as a USDMF. Rabeprazole USDMF includes data on Rabeprazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rabeprazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rabeprazole suppliers with USDMF on PharmaCompass.
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