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Axplora- The partner of choice for complex APIs.
Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.
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USDMF
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Axplora- The 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...
Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.
About the Company : Valsynthese, a privately held CDMO, is a member of the SSE Group. Headquartered in Brig, Switzerland, it has a broad international reach. With over a century of experience in highl...
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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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ABOUT THIS PAGE
A Nitroglycerin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitroglycerin, including repackagers and relabelers. The FDA regulates Nitroglycerin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitroglycerin 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 Nitroglycerin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitroglycerin supplier is an individual or a company that provides Nitroglycerin active pharmaceutical ingredient (API) or Nitroglycerin finished formulations upon request. The Nitroglycerin suppliers may include Nitroglycerin API manufacturers, exporters, distributors and traders.
click here to find a list of Nitroglycerin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitroglycerin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitroglycerin active pharmaceutical ingredient (API) in detail. Different forms of Nitroglycerin DMFs exist exist since differing nations have different regulations, such as Nitroglycerin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitroglycerin DMF submitted to regulatory agencies in the US is known as a USDMF. Nitroglycerin USDMF includes data on Nitroglycerin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitroglycerin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitroglycerin 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 Nitroglycerin Drug Master File in Japan (Nitroglycerin JDMF) empowers Nitroglycerin 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 Nitroglycerin JDMF during the approval evaluation for pharmaceutical products. At the time of Nitroglycerin 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 Nitroglycerin 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 Nitroglycerin Drug Master File in Korea (Nitroglycerin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nitroglycerin. The MFDS reviews the Nitroglycerin KDMF as part of the drug registration process and uses the information provided in the Nitroglycerin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nitroglycerin 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 Nitroglycerin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nitroglycerin suppliers with KDMF on PharmaCompass.
A Nitroglycerin CEP of the European Pharmacopoeia monograph is often referred to as a Nitroglycerin Certificate of Suitability (COS). The purpose of a Nitroglycerin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitroglycerin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitroglycerin to their clients by showing that a Nitroglycerin CEP has been issued for it. The manufacturer submits a Nitroglycerin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitroglycerin CEP holder for the record. Additionally, the data presented in the Nitroglycerin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitroglycerin DMF.
A Nitroglycerin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitroglycerin 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 Nitroglycerin 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 Nitroglycerin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nitroglycerin 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 Nitroglycerin 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 Nitroglycerin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nitroglycerin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nitroglycerin suppliers with NDC on PharmaCompass.
Nitroglycerin 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 Nitroglycerin 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 Nitroglycerin GMP manufacturer or Nitroglycerin GMP API supplier for your needs.
A Nitroglycerin CoA (Certificate of Analysis) is a formal document that attests to Nitroglycerin's compliance with Nitroglycerin specifications and serves as a tool for batch-level quality control.
Nitroglycerin CoA mostly includes findings from lab analyses of a specific batch. For each Nitroglycerin 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.
Nitroglycerin may be tested according to a variety of international standards, such as European Pharmacopoeia (Nitroglycerin EP), Nitroglycerin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nitroglycerin USP).
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