Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
01 1Rochem International Inc
02 2SPI Pharma
03 1DKSH
04 1Cadila Pharmaceuticals
05 1Dead Sea Periclase
06 1Dr. Paul Lohmann GmbH KG
07 1Guangzhou Tosun Pharmaceutical
08 1Hainan Poly Pharm
09 1Meha Chemicals
10 1Morton Salt
11 1Nitika Pharmaceutical Specialities
12 1Particle Dynamics International, LLC.
13 2Priti Industries
14 1Quality Chemicals
15 1Rumit Group of Companies
16 1Taurus Chemicals
17 3Tomita Pharmaceutical
18 1Vasa Pharmachem
01 2China
02 1Germany
03 8India
04 1Israel
05 3Japan
06 1Spain
07 1Switzerland
08 5U.S.A
01 5Active
02 6Inactive
03 11Blank
01 5Valid
02 17Blank
01 22Blank
01 1WC-0187
02 1WC-0452
03 1WC-0551
04 19Blank
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39418
Submission : 2024-03-06
Status : Active
Type : II
Certificate Number : R0-CEP 2022-054 - Rev 00
Issue Date : 2023-02-10
Type : Chemical
Substance Number : 39
Status : Valid
NDC Package Code : 12784-188
Start Marketing Date : 2012-12-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (97kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Certificate Number : R1-CEP 2008-190 - Rev 00
Issue Date : 2014-10-07
Type : Chemical
Substance Number : 39
Status : Valid
NDC Package Code : 12784-188
Start Marketing Date : 2012-12-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (97kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-14
Pay. Date : 2013-06-27
DMF Number : 10532
Submission : 1993-10-15
Status : Active
Type : II
Certificate Number : R1-CEP 2001-344 - Rev 03
Issue Date : 2016-09-01
Type : Chemical
Substance Number : 39
Status : Valid
NDC Package Code : 50917-840
Start Marketing Date : 2024-02-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36567
Submission : 2021-12-16
Status : Active
Type : II
Certificate Number : R0-CEP 2022-010 - Rev 00
Issue Date : 2022-07-26
Type : Chemical
Substance Number : 39
Status : Valid
NDC Package Code : 14335-300
Start Marketing Date : 2021-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38884
Submission : 2023-11-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38887
Submission : 2023-11-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18190
Submission : 2005-03-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17051
Submission : 2003-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28926
Submission : 2014-12-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29845
Submission : 2015-09-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8011
Submission : 1989-04-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22549
Submission : 2009-02-19
Status : Inactive
Type : II
Date of Issue : 2019-09-11
Valid Till : 2022-09-10
Written Confirmation Number : WC-0452
Address of the Firm :
Date of Issue : 2024-05-20
Valid Till : 2027-05-20
Written Confirmation Number : WC-0551
Address of the Firm :
Certificate Number : R1-CEP 2013-020 - Rev 01
Issue Date : 2020-02-27
Type : Chemical
Substance Number : 39
Status : Valid
Date of Issue : 2020-02-24
Valid Till : 2022-07-02
Written Confirmation Number : WC-0187
Address of the Firm :
A Magnesium Hydroxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magnesium Hydroxide, including repackagers and relabelers. The FDA regulates Magnesium Hydroxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magnesium Hydroxide 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 Magnesium Hydroxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Magnesium Hydroxide supplier is an individual or a company that provides Magnesium Hydroxide active pharmaceutical ingredient (API) or Magnesium Hydroxide finished formulations upon request. The Magnesium Hydroxide suppliers may include Magnesium Hydroxide API manufacturers, exporters, distributors and traders.
click here to find a list of Magnesium Hydroxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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