X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
85
PharmaCompass offers a list of Pemoline 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 Pemoline manufacturer or Pemoline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pemoline manufacturer or Pemoline supplier.
PharmaCompass also assists you with knowing the Pemoline API Price utilized in the formulation of products. Pemoline API Price is not always fixed or binding as the Pemoline Price is obtained through a variety of data sources. The Pemoline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pemoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemoline, including repackagers and relabelers. The FDA regulates Pemoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemoline 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 Pemoline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pemoline supplier is an individual or a company that provides Pemoline active pharmaceutical ingredient (API) or Pemoline finished formulations upon request. The Pemoline suppliers may include Pemoline API manufacturers, exporters, distributors and traders.
click here to find a list of Pemoline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pemoline DMF (Drug Master File) is a document detailing the whole manufacturing process of Pemoline active pharmaceutical ingredient (API) in detail. Different forms of Pemoline DMFs exist exist since differing nations have different regulations, such as Pemoline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pemoline DMF submitted to regulatory agencies in the US is known as a USDMF. Pemoline USDMF includes data on Pemoline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pemoline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pemoline 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 Pemoline Drug Master File in Japan (Pemoline JDMF) empowers Pemoline 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 Pemoline JDMF during the approval evaluation for pharmaceutical products. At the time of Pemoline 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 Pemoline 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 Pemoline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pemoline 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 Pemoline 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 Pemoline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pemoline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pemoline suppliers with NDC on PharmaCompass.
Pemoline 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 Pemoline 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 Pemoline GMP manufacturer or Pemoline GMP API supplier for your needs.
A Pemoline CoA (Certificate of Analysis) is a formal document that attests to Pemoline's compliance with Pemoline specifications and serves as a tool for batch-level quality control.
Pemoline CoA mostly includes findings from lab analyses of a specific batch. For each Pemoline 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.
Pemoline may be tested according to a variety of international standards, such as European Pharmacopoeia (Pemoline EP), Pemoline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pemoline USP).
Market Place
