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API SUPPLIERS
Axplora is your partner of choice for complex APIs.
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USDMF
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Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
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Drugs in Development
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DOSAGE - SPRAY, METERED;SUBLINGUAL - 0.4MG/SP...DOSAGE - SPRAY, METERED;SUBLINGUAL - 0.4MG/SPRAY
USFDA APPLICATION NUMBER - 18705
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/HR
USFDA APPLICATION NUMBER - 20145
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.2MG/HR
USFDA APPLICATION NUMBER - 20145
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.3MG/HR
USFDA APPLICATION NUMBER - 20145
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.4MG/HR
USFDA APPLICATION NUMBER - 20145
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.6MG/HR
USFDA APPLICATION NUMBER - 20145
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.8MG/HR
USFDA APPLICATION NUMBER - 20145
DOSAGE - POWDER;SUBLINGUAL - 0.4MG/PACKET
USFDA APPLICATION NUMBER - 208424
DOSAGE - TABLET;SUBLINGUAL - 0.3MG
USFDA APPLICATION NUMBER - 21134
DOSAGE - TABLET;SUBLINGUAL - 0.4MG
USFDA APPLICATION NUMBER - 21134
DOSAGE - TABLET;SUBLINGUAL - 0.6MG
USFDA APPLICATION NUMBER - 21134
DOSAGE - OINTMENT;INTRA-ANAL - 0.4%
USFDA APPLICATION NUMBER - 21359
DOSAGE - AEROSOL, METERED;SUBLINGUAL - 0.4MG/...DOSAGE - AEROSOL, METERED;SUBLINGUAL - 0.4MG/SPRAY
USFDA APPLICATION NUMBER - 21780
DOSAGE - OINTMENT;TRANSDERMAL - 2%
USFDA APPLICATION NUMBER - 87355
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PharmaCompass offers a list of Nitroglycerin 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 Nitroglycerin manufacturer or Nitroglycerin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nitroglycerin manufacturer or Nitroglycerin supplier.
PharmaCompass also assists you with knowing the Nitroglycerin API Price utilized in the formulation of products. Nitroglycerin API Price is not always fixed or binding as the Nitroglycerin Price is obtained through a variety of data sources. The Nitroglycerin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nitrocontin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrocontin, including repackagers and relabelers. The FDA regulates Nitrocontin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrocontin 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 Nitrocontin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitrocontin supplier is an individual or a company that provides Nitrocontin active pharmaceutical ingredient (API) or Nitrocontin finished formulations upon request. The Nitrocontin suppliers may include Nitrocontin API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrocontin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitrocontin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitrocontin active pharmaceutical ingredient (API) in detail. Different forms of Nitrocontin DMFs exist exist since differing nations have different regulations, such as Nitrocontin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitrocontin DMF submitted to regulatory agencies in the US is known as a USDMF. Nitrocontin USDMF includes data on Nitrocontin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitrocontin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitrocontin 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 Nitrocontin Drug Master File in Japan (Nitrocontin JDMF) empowers Nitrocontin 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 Nitrocontin JDMF during the approval evaluation for pharmaceutical products. At the time of Nitrocontin 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 Nitrocontin suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nitrocontin Drug Master File in Korea (Nitrocontin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nitrocontin. The MFDS reviews the Nitrocontin KDMF as part of the drug registration process and uses the information provided in the Nitrocontin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nitrocontin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Nitrocontin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nitrocontin suppliers with KDMF on PharmaCompass.
A Nitrocontin CEP of the European Pharmacopoeia monograph is often referred to as a Nitrocontin Certificate of Suitability (COS). The purpose of a Nitrocontin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitrocontin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitrocontin to their clients by showing that a Nitrocontin CEP has been issued for it. The manufacturer submits a Nitrocontin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitrocontin CEP holder for the record. Additionally, the data presented in the Nitrocontin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitrocontin DMF.
A Nitrocontin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitrocontin 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 Nitrocontin 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 Nitrocontin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nitrocontin 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 Nitrocontin 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 Nitrocontin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nitrocontin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nitrocontin suppliers with NDC on PharmaCompass.
Nitrocontin 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 Nitrocontin 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 Nitrocontin GMP manufacturer or Nitrocontin GMP API supplier for your needs.
A Nitrocontin CoA (Certificate of Analysis) is a formal document that attests to Nitrocontin's compliance with Nitrocontin specifications and serves as a tool for batch-level quality control.
Nitrocontin CoA mostly includes findings from lab analyses of a specific batch. For each Nitrocontin 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.
Nitrocontin may be tested according to a variety of international standards, such as European Pharmacopoeia (Nitrocontin EP), Nitrocontin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nitrocontin USP).
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