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GDUFA

DMF Review : Complete

Rev. Date : 2016-06-27

Pay. Date : 2016-09-12

DMF Number : 21722

Submission : 2008-06-10

Status : Active

Type : II

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Looking for 471-34-1 / Calcium Carbonate API manufacturers, exporters & distributors?

Calcium Carbonate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Calcium Carbonate 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 Carbonate manufacturer or Calcium Carbonate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Carbonate manufacturer or Calcium Carbonate supplier.

API | Excipient name

Calcium Carbonate

Synonyms

Aragonite, 471-34-1, Limestone, Calcite, Chalk, Carbonic acid calcium salt (1:1)

Cas Number

471-34-1

Unique Ingredient Identifier (UNII)

H0G9379FGK

About Calcium Carbonate

Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.

Chemcarb Manufacturers

A Chemcarb manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chemcarb, including repackagers and relabelers. The FDA regulates Chemcarb manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chemcarb 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 Chemcarb manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

Chemcarb Suppliers

A Chemcarb supplier is an individual or a company that provides Chemcarb active pharmaceutical ingredient (API) or Chemcarb finished formulations upon request. The Chemcarb suppliers may include Chemcarb API manufacturers, exporters, distributors and traders.

click here to find a list of Chemcarb suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

Chemcarb USDMF

A Chemcarb DMF (Drug Master File) is a document detailing the whole manufacturing process of Chemcarb active pharmaceutical ingredient (API) in detail. Different forms of Chemcarb DMFs exist exist since differing nations have different regulations, such as Chemcarb USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Chemcarb DMF submitted to regulatory agencies in the US is known as a USDMF. Chemcarb USDMF includes data on Chemcarb's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chemcarb USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Chemcarb suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.