01 1COSMA S.p.A
02 1Chemi SpA
03 1Napp Technologies
04 1POLI INDUSTRIA CHIMICA SPA
05 1Ramdev Chemicals Pvt Ltd
06 1Symed Labs
07 1UCB Pharma S.A
01 3HYDROXYZINE PAMOATE
02 2HYDROXYZINE PAMOATE USP
03 1HYDROXYZINE PAMOATE USP. XX
04 1MFG & CONTRL PROCEDS.--PRODUCT. OF HYDROXYZINE PAMOATE NF XIV-LODI,NJ
01 1Belgium
02 2India
03 3Italy
04 1U.S.A
01 3Active
02 4Inactive
01 3Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4629
Submission : 1982-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 4514
Submission : 1982-04-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3508
Submission : 1979-04-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2808
Submission : 1976-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-04
Pay. Date : 2024-08-13
DMF Number : 36954
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-07
Pay. Date : 2023-07-27
DMF Number : 38535
Submission : 2023-07-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3695
Submission : 1980-01-16
Status : Inactive
Type : II
A Hydroxyzine Pamoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxyzine Pamoate, including repackagers and relabelers. The FDA regulates Hydroxyzine Pamoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxyzine Pamoate 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 Hydroxyzine Pamoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxyzine Pamoate supplier is an individual or a company that provides Hydroxyzine Pamoate active pharmaceutical ingredient (API) or Hydroxyzine Pamoate finished formulations upon request. The Hydroxyzine Pamoate suppliers may include Hydroxyzine Pamoate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxyzine Pamoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxyzine Pamoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxyzine Pamoate active pharmaceutical ingredient (API) in detail. Different forms of Hydroxyzine Pamoate DMFs exist exist since differing nations have different regulations, such as Hydroxyzine Pamoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxyzine Pamoate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxyzine Pamoate USDMF includes data on Hydroxyzine Pamoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxyzine Pamoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxyzine Pamoate suppliers with USDMF on PharmaCompass.
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