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  • SPRAY, METERED;SUBLINGUAL - 0.4MG/SPRAY
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.2MG/HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.3MG/HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.4MG/HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.6MG/HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.8MG/HR
  • POWDER;SUBLINGUAL - 0.4MG/PACKET
  • TABLET;SUBLINGUAL - 0.3MG
  • TABLET;SUBLINGUAL - 0.4MG
  • TABLET;SUBLINGUAL - 0.6MG
  • OINTMENT;INTRA-ANAL - 0.4%
  • AEROSOL, METERED;SUBLINGUAL - 0.4MG/SPRAY
  • OINTMENT;TRANSDERMAL - 2%

Looking for 55-63-0 / Nitroglycerin API manufacturers, exporters & distributors?

Nitroglycerin manufacturers, exporters & distributors 1

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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.

API | Excipient name

Nitroglycerin

Synonyms

Glyceryl trinitrate, Trinitroglycerin, Nitrostat, 55-63-0, Nitroglycerine, Nitroglycerol

Cas Number

55-63-0

Unique Ingredient Identifier (UNII)

G59M7S0WS3

About Nitroglycerin

A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.

1,3-dinitrooxypropan-2-yl nitrate Manufacturers

A 1,3-dinitrooxypropan-2-yl nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,3-dinitrooxypropan-2-yl nitrate, including repackagers and relabelers. The FDA regulates 1,3-dinitrooxypropan-2-yl nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,3-dinitrooxypropan-2-yl 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 1,3-dinitrooxypropan-2-yl nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

1,3-dinitrooxypropan-2-yl nitrate Suppliers

A 1,3-dinitrooxypropan-2-yl nitrate supplier is an individual or a company that provides 1,3-dinitrooxypropan-2-yl nitrate active pharmaceutical ingredient (API) or 1,3-dinitrooxypropan-2-yl nitrate finished formulations upon request. The 1,3-dinitrooxypropan-2-yl nitrate suppliers may include 1,3-dinitrooxypropan-2-yl nitrate API manufacturers, exporters, distributors and traders.

click here to find a list of 1,3-dinitrooxypropan-2-yl nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

1,3-dinitrooxypropan-2-yl nitrate USDMF

A 1,3-dinitrooxypropan-2-yl nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,3-dinitrooxypropan-2-yl nitrate active pharmaceutical ingredient (API) in detail. Different forms of 1,3-dinitrooxypropan-2-yl nitrate DMFs exist exist since differing nations have different regulations, such as 1,3-dinitrooxypropan-2-yl nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 1,3-dinitrooxypropan-2-yl nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. 1,3-dinitrooxypropan-2-yl nitrate USDMF includes data on 1,3-dinitrooxypropan-2-yl nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,3-dinitrooxypropan-2-yl nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 1,3-dinitrooxypropan-2-yl nitrate suppliers with USDMF on PharmaCompass.

1,3-dinitrooxypropan-2-yl nitrate JDMF

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 1,3-dinitrooxypropan-2-yl nitrate Drug Master File in Japan (1,3-dinitrooxypropan-2-yl nitrate JDMF) empowers 1,3-dinitrooxypropan-2-yl nitrate 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 1,3-dinitrooxypropan-2-yl nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of 1,3-dinitrooxypropan-2-yl nitrate 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 1,3-dinitrooxypropan-2-yl nitrate suppliers with JDMF on PharmaCompass.

1,3-dinitrooxypropan-2-yl nitrate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a 1,3-dinitrooxypropan-2-yl nitrate Drug Master File in Korea (1,3-dinitrooxypropan-2-yl nitrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,3-dinitrooxypropan-2-yl nitrate. The MFDS reviews the 1,3-dinitrooxypropan-2-yl nitrate KDMF as part of the drug registration process and uses the information provided in the 1,3-dinitrooxypropan-2-yl nitrate KDMF to evaluate the safety and efficacy of the drug.

After submitting a 1,3-dinitrooxypropan-2-yl nitrate 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 1,3-dinitrooxypropan-2-yl nitrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 1,3-dinitrooxypropan-2-yl nitrate suppliers with KDMF on PharmaCompass.

1,3-dinitrooxypropan-2-yl nitrate CEP

A 1,3-dinitrooxypropan-2-yl nitrate CEP of the European Pharmacopoeia monograph is often referred to as a 1,3-dinitrooxypropan-2-yl nitrate Certificate of Suitability (COS). The purpose of a 1,3-dinitrooxypropan-2-yl nitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1,3-dinitrooxypropan-2-yl nitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1,3-dinitrooxypropan-2-yl nitrate to their clients by showing that a 1,3-dinitrooxypropan-2-yl nitrate CEP has been issued for it. The manufacturer submits a 1,3-dinitrooxypropan-2-yl nitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1,3-dinitrooxypropan-2-yl nitrate CEP holder for the record. Additionally, the data presented in the 1,3-dinitrooxypropan-2-yl nitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1,3-dinitrooxypropan-2-yl nitrate DMF.

A 1,3-dinitrooxypropan-2-yl nitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1,3-dinitrooxypropan-2-yl 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 1,3-dinitrooxypropan-2-yl nitrate suppliers with CEP (COS) on PharmaCompass.

1,3-dinitrooxypropan-2-yl nitrate NDC

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 1,3-dinitrooxypropan-2-yl nitrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 1,3-dinitrooxypropan-2-yl nitrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 1,3-dinitrooxypropan-2-yl 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain 1,3-dinitrooxypropan-2-yl nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1,3-dinitrooxypropan-2-yl nitrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 1,3-dinitrooxypropan-2-yl nitrate suppliers with NDC on PharmaCompass.

1,3-dinitrooxypropan-2-yl nitrate GMP

1,3-dinitrooxypropan-2-yl 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 1,3-dinitrooxypropan-2-yl 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 1,3-dinitrooxypropan-2-yl nitrate GMP manufacturer or 1,3-dinitrooxypropan-2-yl nitrate GMP API supplier for your needs.

1,3-dinitrooxypropan-2-yl nitrate CoA

A 1,3-dinitrooxypropan-2-yl nitrate CoA (Certificate of Analysis) is a formal document that attests to 1,3-dinitrooxypropan-2-yl nitrate's compliance with 1,3-dinitrooxypropan-2-yl nitrate specifications and serves as a tool for batch-level quality control.

1,3-dinitrooxypropan-2-yl nitrate CoA mostly includes findings from lab analyses of a specific batch. For each 1,3-dinitrooxypropan-2-yl 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.

1,3-dinitrooxypropan-2-yl nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (1,3-dinitrooxypropan-2-yl nitrate EP), 1,3-dinitrooxypropan-2-yl nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1,3-dinitrooxypropan-2-yl nitrate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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