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DOSAGE - FILM;SUBLINGUAL - 10MG
USFDA APPLICATION NUMBER - 210875
DOSAGE - FILM;SUBLINGUAL - 15MG
USFDA APPLICATION NUMBER - 210875
DOSAGE - FILM;SUBLINGUAL - 20MG
USFDA APPLICATION NUMBER - 210875
DOSAGE - FILM;SUBLINGUAL - 25MG
USFDA APPLICATION NUMBER - 210875
DOSAGE - FILM;SUBLINGUAL - 30MG
USFDA APPLICATION NUMBER - 210875
DOSAGE - INJECTABLE;SUBCUTANEOUS - 30MG/3ML (...DOSAGE - INJECTABLE;SUBCUTANEOUS - 30MG/3ML (10MG/ML)
USFDA APPLICATION NUMBER - 21264
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PharmaCompass offers a list of Apomorphine Hydrochloride 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 Apomorphine Hydrochloride manufacturer or Apomorphine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Apomorphine Hydrochloride manufacturer or Apomorphine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Apomorphine Hydrochloride API Price utilized in the formulation of products. Apomorphine Hydrochloride API Price is not always fixed or binding as the Apomorphine Hydrochloride Price is obtained through a variety of data sources. The Apomorphine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Apomorphine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apomorphine HCl, including repackagers and relabelers. The FDA regulates Apomorphine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apomorphine HCl 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 Apomorphine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apomorphine HCl supplier is an individual or a company that provides Apomorphine HCl active pharmaceutical ingredient (API) or Apomorphine HCl finished formulations upon request. The Apomorphine HCl suppliers may include Apomorphine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Apomorphine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apomorphine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Apomorphine HCl active pharmaceutical ingredient (API) in detail. Different forms of Apomorphine HCl DMFs exist exist since differing nations have different regulations, such as Apomorphine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apomorphine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Apomorphine HCl USDMF includes data on Apomorphine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apomorphine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Apomorphine HCl 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 Apomorphine HCl Drug Master File in Japan (Apomorphine HCl JDMF) empowers Apomorphine HCl 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 Apomorphine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Apomorphine HCl 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 Apomorphine HCl suppliers with JDMF on PharmaCompass.
A Apomorphine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Apomorphine HCl Certificate of Suitability (COS). The purpose of a Apomorphine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Apomorphine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Apomorphine HCl to their clients by showing that a Apomorphine HCl CEP has been issued for it. The manufacturer submits a Apomorphine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Apomorphine HCl CEP holder for the record. Additionally, the data presented in the Apomorphine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Apomorphine HCl DMF.
A Apomorphine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Apomorphine HCl 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 Apomorphine HCl suppliers with CEP (COS) on PharmaCompass.
A Apomorphine HCl written confirmation (Apomorphine HCl WC) is an official document issued by a regulatory agency to a Apomorphine HCl manufacturer, verifying that the manufacturing facility of a Apomorphine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Apomorphine HCl APIs or Apomorphine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Apomorphine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Apomorphine HCl 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 Apomorphine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Apomorphine HCl 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 Apomorphine HCl 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 Apomorphine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Apomorphine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Apomorphine HCl suppliers with NDC on PharmaCompass.
Apomorphine HCl 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 Apomorphine HCl 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 Apomorphine HCl GMP manufacturer or Apomorphine HCl GMP API supplier for your needs.
A Apomorphine HCl CoA (Certificate of Analysis) is a formal document that attests to Apomorphine HCl's compliance with Apomorphine HCl specifications and serves as a tool for batch-level quality control.
Apomorphine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Apomorphine HCl 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.
Apomorphine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Apomorphine HCl EP), Apomorphine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Apomorphine HCl USP).
