SPI Pharma has been solving formulation challenges using superior functional materials.
01 1SPI Pharma
02 3Caltron Clays & Chemicals
03 1Chr. Hansen AS
04 3Delavau LLC
05 1Deseret Laboratories
06 1Hindustan Phosphates
07 6JM Huber Corporation
08 1Nutri Granulations
09 1Omya Internatinal AG
10 3Particle Dynamics International, LLC.
11 2SCORA SA
12 1Takehara Kagaku Kogyo
13 2UNILEVER CANADA INC.
14 3Blank
SPI Pharma has been solving formulation challenges using superior functional materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39027
Submission : 2024-06-14
Status :
Type : II
A Calcium Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Carbonate, including repackagers and relabelers. The FDA regulates Calcium Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Carbonate 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 Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Carbonate supplier is an individual or a company that provides Calcium Carbonate active pharmaceutical ingredient (API) or Calcium Carbonate finished formulations upon request. The Calcium Carbonate suppliers may include Calcium Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Carbonate active pharmaceutical ingredient (API) in detail. Different forms of Calcium Carbonate DMFs exist exist since differing nations have different regulations, such as Calcium Carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Carbonate USDMF includes data on Calcium Carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Carbonate suppliers with USDMF on PharmaCompass.
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