Synopsis
0
CEP/COS
0
EU WC
0
KDMF
0
VMF
0
FDF
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Lubricants & Glidants
Direct Compression
Topical
Film Formers & Plasticizers
Empty Capsules
Granulation
Co-Processed Excipients
Disintegrants & Superdisintegrants
Parenteral
Taste Masking
API Stability Enhancers
Solubilizers
Vegetarian Capsules
Coloring Agents
Emulsifying Agents
Chewable & Orodispersible Aids
Rheology Modifiers
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Cobamamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cobamamide, including repackagers and relabelers. The FDA regulates Cobamamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cobamamide 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 Cobamamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cobamamide supplier is an individual or a company that provides Cobamamide active pharmaceutical ingredient (API) or Cobamamide finished formulations upon request. The Cobamamide suppliers may include Cobamamide API manufacturers, exporters, distributors and traders.
click here to find a list of Cobamamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cobamamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Cobamamide active pharmaceutical ingredient (API) in detail. Different forms of Cobamamide DMFs exist exist since differing nations have different regulations, such as Cobamamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cobamamide DMF submitted to regulatory agencies in the US is known as a USDMF. Cobamamide USDMF includes data on Cobamamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cobamamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cobamamide suppliers with USDMF on PharmaCompass.
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 Cobamamide Drug Master File in Japan (Cobamamide JDMF) empowers Cobamamide 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 Cobamamide JDMF during the approval evaluation for pharmaceutical products. At the time of Cobamamide 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 Cobamamide suppliers with JDMF on PharmaCompass.
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 Cobamamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cobamamide API and other APIs are published in this directory by the FDA.
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 Cobamamide 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.
The NDC directory also contains data on finished compounded human drug products that contain Cobamamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cobamamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cobamamide suppliers with NDC on PharmaCompass.
Cobamamide 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 Cobamamide 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 Cobamamide GMP manufacturer or Cobamamide GMP API supplier for your needs.
A Cobamamide CoA (Certificate of Analysis) is a formal document that attests to Cobamamide's compliance with Cobamamide specifications and serves as a tool for batch-level quality control.
Cobamamide CoA mostly includes findings from lab analyses of a specific batch. For each Cobamamide 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.
Cobamamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Cobamamide EP), Cobamamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cobamamide USP).
LOOKING FOR A SUPPLIER?
