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List of Drug Master Files (DMF) of Calcium Oxybate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Cambrex Corporation (1)

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01 CALCIUM OXYBATE (1)

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01 U.S.A (1)

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01 Active (1)

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01 Complete (1)

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35873
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2022-06-10
Complete
2022-06-30
2022-05-17
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Looking for 82316-97-0 / Calcium Oxybate API manufacturers, exporters & distributors?

Calcium Oxybate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Calcium Oxybate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Calcium Oxybate manufacturer or Calcium Oxybate supplier for your needs.

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

PharmaCompass also assists you with knowing the Calcium Oxybate API Price utilized in the formulation of products. Calcium Oxybate API Price is not always fixed or binding as the Calcium Oxybate Price is obtained through a variety of data sources. The Calcium Oxybate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Calcium Oxybate

Synonyms

Oxybate calcium, 82316-97-0, 8w24syd6zi, Calcium bis(4-hydroxybutanoate), Einecs 279-930-6, Unii-8w24syd6zi

Cas Number

82316-97-0

Unique Ingredient Identifier (UNII)

8W24SYD6ZI

Calcium Oxybate Manufacturers

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

Calcium Oxybate Suppliers

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

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

Calcium Oxybate USDMF

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

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

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

Calcium Oxybate Manufacturers | Traders | Suppliers

Calcium Oxybate Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Calcium Oxybate

Get in contact with the supplier of your choice:

  1. Cambrex Corporation
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.
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