01 1Anmol Chemicals
02 1MLA Group
03 1Muby Chem
01 3CALCIUM HYDROXIDE USP
01 3India
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41546
Submission : 2025-05-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37657
Submission : 2022-11-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42045
Submission : 2025-08-16
Status : Active
Type : IV
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PharmaCompass offers a list of Calcium Hydroxide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Calcium Hydroxide manufacturer or Calcium Hydroxide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Hydroxide manufacturer or Calcium Hydroxide supplier.
A Calcium Hydroxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Hydroxide, including repackagers and relabelers. The FDA regulates Calcium Hydroxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium 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 Calcium Hydroxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Calcium Hydroxide supplier is an individual or a company that provides Calcium Hydroxide active pharmaceutical ingredient (API) or Calcium Hydroxide finished formulations upon request. The Calcium Hydroxide suppliers may include Calcium Hydroxide API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Hydroxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Calcium Hydroxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Hydroxide active pharmaceutical ingredient (API) in detail. Different forms of Calcium Hydroxide DMFs exist exist since differing nations have different regulations, such as Calcium Hydroxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Hydroxide DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Hydroxide USDMF includes data on Calcium Hydroxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Hydroxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Hydroxide suppliers with USDMF on PharmaCompass.
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