Synopsis
0
USDMF
0
EU WC
0
NDC API
0
VMF
0
FDA Orange Book
0
Australia
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
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
About the Company : ChemExpress is a leading CRO and CDMO partner supporting pharmaceutical and biotech companies worldwide. We specialize in small molecules, biologics, and next-gen modalities includ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
EDQM
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
29
PharmaCompass offers a list of Alfacalcidol 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 Alfacalcidol manufacturer or Alfacalcidol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alfacalcidol manufacturer or Alfacalcidol supplier.
PharmaCompass also assists you with knowing the Alfacalcidol API Price utilized in the formulation of products. Alfacalcidol API Price is not always fixed or binding as the Alfacalcidol Price is obtained through a variety of data sources. The Alfacalcidol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A alphacalcidol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of alphacalcidol, including repackagers and relabelers. The FDA regulates alphacalcidol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. alphacalcidol 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 alphacalcidol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A alphacalcidol supplier is an individual or a company that provides alphacalcidol active pharmaceutical ingredient (API) or alphacalcidol finished formulations upon request. The alphacalcidol suppliers may include alphacalcidol API manufacturers, exporters, distributors and traders.
click here to find a list of alphacalcidol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 alphacalcidol Drug Master File in Japan (alphacalcidol JDMF) empowers alphacalcidol 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 alphacalcidol JDMF during the approval evaluation for pharmaceutical products. At the time of alphacalcidol 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 alphacalcidol suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a alphacalcidol Drug Master File in Korea (alphacalcidol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of alphacalcidol. The MFDS reviews the alphacalcidol KDMF as part of the drug registration process and uses the information provided in the alphacalcidol KDMF to evaluate the safety and efficacy of the drug.
After submitting a alphacalcidol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their alphacalcidol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of alphacalcidol suppliers with KDMF on PharmaCompass.
A alphacalcidol CEP of the European Pharmacopoeia monograph is often referred to as a alphacalcidol Certificate of Suitability (COS). The purpose of a alphacalcidol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of alphacalcidol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of alphacalcidol to their clients by showing that a alphacalcidol CEP has been issued for it. The manufacturer submits a alphacalcidol CEP (COS) as part of the market authorization procedure, and it takes on the role of a alphacalcidol CEP holder for the record. Additionally, the data presented in the alphacalcidol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the alphacalcidol DMF.
A alphacalcidol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. alphacalcidol 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 alphacalcidol suppliers with CEP (COS) on PharmaCompass.
alphacalcidol 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 alphacalcidol 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 alphacalcidol GMP manufacturer or alphacalcidol GMP API supplier for your needs.
A alphacalcidol CoA (Certificate of Analysis) is a formal document that attests to alphacalcidol's compliance with alphacalcidol specifications and serves as a tool for batch-level quality control.
alphacalcidol CoA mostly includes findings from lab analyses of a specific batch. For each alphacalcidol 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.
alphacalcidol may be tested according to a variety of international standards, such as European Pharmacopoeia (alphacalcidol EP), alphacalcidol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (alphacalcidol USP).
