API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
Listed Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
45
PharmaCompass offers a list of Pimecrolimus 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 Pimecrolimus manufacturer or Pimecrolimus supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pimecrolimus manufacturer or Pimecrolimus supplier.
PharmaCompass also assists you with knowing the Pimecrolimus API Price utilized in the formulation of products. Pimecrolimus API Price is not always fixed or binding as the Pimecrolimus Price is obtained through a variety of data sources. The Pimecrolimus Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pimecrolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pimecrolimus, including repackagers and relabelers. The FDA regulates Pimecrolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pimecrolimus 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 Pimecrolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pimecrolimus supplier is an individual or a company that provides Pimecrolimus active pharmaceutical ingredient (API) or Pimecrolimus finished formulations upon request. The Pimecrolimus suppliers may include Pimecrolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Pimecrolimus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pimecrolimus DMF (Drug Master File) is a document detailing the whole manufacturing process of Pimecrolimus active pharmaceutical ingredient (API) in detail. Different forms of Pimecrolimus DMFs exist exist since differing nations have different regulations, such as Pimecrolimus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pimecrolimus DMF submitted to regulatory agencies in the US is known as a USDMF. Pimecrolimus USDMF includes data on Pimecrolimus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pimecrolimus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pimecrolimus suppliers with USDMF on PharmaCompass.
A Pimecrolimus written confirmation (Pimecrolimus WC) is an official document issued by a regulatory agency to a Pimecrolimus manufacturer, verifying that the manufacturing facility of a Pimecrolimus active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pimecrolimus APIs or Pimecrolimus finished pharmaceutical products to another nation, regulatory agencies frequently require a Pimecrolimus WC (written confirmation) as part of the regulatory process.
click here to find a list of Pimecrolimus suppliers with Written Confirmation (WC) 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 Pimecrolimus as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pimecrolimus 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 Pimecrolimus 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 Pimecrolimus and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pimecrolimus NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pimecrolimus suppliers with NDC on PharmaCompass.
Pimecrolimus 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 Pimecrolimus 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 Pimecrolimus GMP manufacturer or Pimecrolimus GMP API supplier for your needs.
A Pimecrolimus CoA (Certificate of Analysis) is a formal document that attests to Pimecrolimus's compliance with Pimecrolimus specifications and serves as a tool for batch-level quality control.
Pimecrolimus CoA mostly includes findings from lab analyses of a specific batch. For each Pimecrolimus 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.
Pimecrolimus may be tested according to a variety of international standards, such as European Pharmacopoeia (Pimecrolimus EP), Pimecrolimus JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pimecrolimus USP).