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API SUPPLIERS
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USDMF
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Pilocarpine Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pilocarpine Nitrate, including repackagers and relabelers. The FDA regulates Pilocarpine Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pilocarpine Nitrate 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 Pilocarpine Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pilocarpine Nitrate supplier is an individual or a company that provides Pilocarpine Nitrate active pharmaceutical ingredient (API) or Pilocarpine Nitrate finished formulations upon request. The Pilocarpine Nitrate suppliers may include Pilocarpine Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Pilocarpine Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pilocarpine Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Pilocarpine Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Pilocarpine Nitrate DMFs exist exist since differing nations have different regulations, such as Pilocarpine Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pilocarpine Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Pilocarpine Nitrate USDMF includes data on Pilocarpine Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pilocarpine Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pilocarpine Nitrate suppliers with USDMF on PharmaCompass.
A Pilocarpine Nitrate CEP of the European Pharmacopoeia monograph is often referred to as a Pilocarpine Nitrate Certificate of Suitability (COS). The purpose of a Pilocarpine Nitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pilocarpine Nitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pilocarpine Nitrate to their clients by showing that a Pilocarpine Nitrate CEP has been issued for it. The manufacturer submits a Pilocarpine Nitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pilocarpine Nitrate CEP holder for the record. Additionally, the data presented in the Pilocarpine Nitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pilocarpine Nitrate DMF.
A Pilocarpine Nitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pilocarpine Nitrate 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 Pilocarpine Nitrate suppliers with CEP (COS) 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 Pilocarpine Nitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pilocarpine Nitrate 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 Pilocarpine Nitrate 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 Pilocarpine Nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pilocarpine Nitrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pilocarpine Nitrate suppliers with NDC on PharmaCompass.
Pilocarpine Nitrate 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 Pilocarpine Nitrate 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 Pilocarpine Nitrate GMP manufacturer or Pilocarpine Nitrate GMP API supplier for your needs.
A Pilocarpine Nitrate CoA (Certificate of Analysis) is a formal document that attests to Pilocarpine Nitrate's compliance with Pilocarpine Nitrate specifications and serves as a tool for batch-level quality control.
Pilocarpine Nitrate CoA mostly includes findings from lab analyses of a specific batch. For each Pilocarpine Nitrate 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.
Pilocarpine Nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Pilocarpine Nitrate EP), Pilocarpine Nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pilocarpine Nitrate USP).
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