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South Africa
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API SUPPLIERS
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USDMF
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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
Aspen API. More than just an API™
About the Company : Aspen API is a cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. The company supplies a broad portfolio of over 50 high-qual...
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
About the Company : Pharmathen, established in 1969, has emerged as a leading in-house development partner in Europe. It specializes in the development, registration, manufacturing & life-cycle manage...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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Kirsch Pharma
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ABOUT THIS PAGE
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PharmaCompass offers a list of Nusinersen API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nusinersen manufacturer or Nusinersen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nusinersen manufacturer or Nusinersen supplier.
A Nusinersen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nusinersen, including repackagers and relabelers. The FDA regulates Nusinersen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nusinersen 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 Nusinersen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nusinersen supplier is an individual or a company that provides Nusinersen active pharmaceutical ingredient (API) or Nusinersen finished formulations upon request. The Nusinersen suppliers may include Nusinersen API manufacturers, exporters, distributors and traders.
click here to find a list of Nusinersen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nusinersen DMF (Drug Master File) is a document detailing the whole manufacturing process of Nusinersen active pharmaceutical ingredient (API) in detail. Different forms of Nusinersen DMFs exist exist since differing nations have different regulations, such as Nusinersen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nusinersen DMF submitted to regulatory agencies in the US is known as a USDMF. Nusinersen USDMF includes data on Nusinersen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nusinersen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nusinersen suppliers with USDMF 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 Nusinersen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nusinersen 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 Nusinersen 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 Nusinersen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nusinersen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nusinersen suppliers with NDC on PharmaCompass.
Nusinersen 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 Nusinersen GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nusinersen GMP manufacturer or Nusinersen GMP API supplier for your needs.
A Nusinersen CoA (Certificate of Analysis) is a formal document that attests to Nusinersen's compliance with Nusinersen specifications and serves as a tool for batch-level quality control.
Nusinersen CoA mostly includes findings from lab analyses of a specific batch. For each Nusinersen 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.
Nusinersen may be tested according to a variety of international standards, such as European Pharmacopoeia (Nusinersen EP), Nusinersen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nusinersen USP).
