Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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Canada
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South Africa
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
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...
Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.
About the Company : Anhui Ribobay Pharmaceutical Co., Ltd., known as Ribobay, was established in August 2021 as a fully owned subsidiary of General Biol. Situated in the Quanjiao industry Zone in Chuz...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
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-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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Drugs in Development
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Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Solution For Injection
Dosage Strength : 12MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
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Faran Shimi Pharmaceutical
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Controlled & Modified Release
Fillers, Diluents & Binders
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NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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APIs
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25 Jun 2019
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28 Aug 2018
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10 Dec 2018
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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, Price,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.
PharmaCompass also assists you with knowing the Nusinersen API Price utilized in the formulation of products. Nusinersen API Price is not always fixed or binding as the Nusinersen Price is obtained through a variety of data sources. The Nusinersen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Spinraza manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spinraza, including repackagers and relabelers. The FDA regulates Spinraza manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spinraza 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 Spinraza manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Spinraza supplier is an individual or a company that provides Spinraza active pharmaceutical ingredient (API) or Spinraza finished formulations upon request. The Spinraza suppliers may include Spinraza API manufacturers, exporters, distributors and traders.
click here to find a list of Spinraza suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Spinraza DMF (Drug Master File) is a document detailing the whole manufacturing process of Spinraza active pharmaceutical ingredient (API) in detail. Different forms of Spinraza DMFs exist exist since differing nations have different regulations, such as Spinraza USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spinraza DMF submitted to regulatory agencies in the US is known as a USDMF. Spinraza USDMF includes data on Spinraza's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spinraza USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Spinraza 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 Spinraza as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Spinraza 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 Spinraza 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 Spinraza and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Spinraza NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Spinraza suppliers with NDC on PharmaCompass.
Spinraza 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 Spinraza 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 Spinraza GMP manufacturer or Spinraza GMP API supplier for your needs.
A Spinraza CoA (Certificate of Analysis) is a formal document that attests to Spinraza's compliance with Spinraza specifications and serves as a tool for batch-level quality control.
Spinraza CoA mostly includes findings from lab analyses of a specific batch. For each Spinraza 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.
Spinraza may be tested according to a variety of international standards, such as European Pharmacopoeia (Spinraza EP), Spinraza JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Spinraza USP).
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