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  • FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
  • SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
  • SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
  • INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
  • INJECTABLE;INJECTION - 1MG/ML
  • INJECTABLE;INJECTION - 1MG/ML
  • INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

Looking for 68-19-9 / Vitamin B12 API manufacturers, exporters & distributors?

Vitamin B12 manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Vitamin B12 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 Vitamin B12 manufacturer or Vitamin B12 supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vitamin B12 manufacturer or Vitamin B12 supplier.

PharmaCompass also assists you with knowing the Vitamin B12 API Price utilized in the formulation of products. Vitamin B12 API Price is not always fixed or binding as the Vitamin B12 Price is obtained through a variety of data sources. The Vitamin B12 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vitamin B12

Synonyms

68-19-9, Cyanocob(iii)alamin, Vitamin b12 complex, Dsstox_cid_24346, Dsstox_rid_80159, Dsstox_gsid_44346

Cas Number

68-19-9

About Vitamin B12

A cobalt-containing coordination compound produced by intestinal micro-organisms and found also in soil and water. Higher plants do not concentrate vitamin B 12 from the soil and so are a poor source of the substance as compared with animal tissues. INTRINSIC FACTOR is important for the assimilation of vitamin B 12.

Vitamin B12 Manufacturers

A Vitamin B12 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin B12, including repackagers and relabelers. The FDA regulates Vitamin B12 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin B12 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 Vitamin B12 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Vitamin B12 Suppliers

A Vitamin B12 supplier is an individual or a company that provides Vitamin B12 active pharmaceutical ingredient (API) or Vitamin B12 finished formulations upon request. The Vitamin B12 suppliers may include Vitamin B12 API manufacturers, exporters, distributors and traders.

click here to find a list of Vitamin B12 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Vitamin B12 USDMF

A Vitamin B12 DMF (Drug Master File) is a document detailing the whole manufacturing process of Vitamin B12 active pharmaceutical ingredient (API) in detail. Different forms of Vitamin B12 DMFs exist exist since differing nations have different regulations, such as Vitamin B12 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Vitamin B12 DMF submitted to regulatory agencies in the US is known as a USDMF. Vitamin B12 USDMF includes data on Vitamin B12's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vitamin B12 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Vitamin B12 suppliers with USDMF on PharmaCompass.

Vitamin B12 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Vitamin B12 Drug Master File in Japan (Vitamin B12 JDMF) empowers Vitamin B12 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Vitamin B12 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin B12 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Vitamin B12 suppliers with JDMF on PharmaCompass.

Vitamin B12 CEP

A Vitamin B12 CEP of the European Pharmacopoeia monograph is often referred to as a Vitamin B12 Certificate of Suitability (COS). The purpose of a Vitamin B12 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vitamin B12 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vitamin B12 to their clients by showing that a Vitamin B12 CEP has been issued for it. The manufacturer submits a Vitamin B12 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vitamin B12 CEP holder for the record. Additionally, the data presented in the Vitamin B12 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vitamin B12 DMF.

A Vitamin B12 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vitamin B12 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Vitamin B12 suppliers with CEP (COS) on PharmaCompass.

Vitamin B12 NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Vitamin B12 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Vitamin B12 API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Vitamin B12 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Vitamin B12 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vitamin B12 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Vitamin B12 suppliers with NDC on PharmaCompass.

Vitamin B12 GMP

Vitamin B12 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Vitamin B12 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Vitamin B12 GMP manufacturer or Vitamin B12 GMP API supplier for your needs.

Vitamin B12 CoA

A Vitamin B12 CoA (Certificate of Analysis) is a formal document that attests to Vitamin B12's compliance with Vitamin B12 specifications and serves as a tool for batch-level quality control.

Vitamin B12 CoA mostly includes findings from lab analyses of a specific batch. For each Vitamin B12 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Vitamin B12 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vitamin B12 EP), Vitamin B12 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vitamin B12 USP).

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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