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