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Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
About the Company : Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like A...
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23 Jun 2021
// BUSINESSWIRE
23 Jun 2021
// BUSINESSWIRE
21 Jun 2019
// Angus Liu FIERCE PHARMA
25 May 2017
// Zachary Brennan RAPS
15 Feb 2017
// Gareth MacDonald IN PHARMATECHNOLOGIST
23 Jan 2015
// EJ Lane FIERCE PHARMA
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ABOUT THIS PAGE
A Glatiramer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glatiramer, including repackagers and relabelers. The FDA regulates Glatiramer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glatiramer 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 Glatiramer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glatiramer supplier is an individual or a company that provides Glatiramer active pharmaceutical ingredient (API) or Glatiramer finished formulations upon request. The Glatiramer suppliers may include Glatiramer API manufacturers, exporters, distributors and traders.
click here to find a list of Glatiramer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glatiramer DMF (Drug Master File) is a document detailing the whole manufacturing process of Glatiramer active pharmaceutical ingredient (API) in detail. Different forms of Glatiramer DMFs exist exist since differing nations have different regulations, such as Glatiramer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glatiramer DMF submitted to regulatory agencies in the US is known as a USDMF. Glatiramer USDMF includes data on Glatiramer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glatiramer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glatiramer 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 Glatiramer as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glatiramer 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 Glatiramer 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 Glatiramer and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glatiramer NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glatiramer suppliers with NDC on PharmaCompass.
Glatiramer 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 Glatiramer 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 Glatiramer GMP manufacturer or Glatiramer GMP API supplier for your needs.
A Glatiramer CoA (Certificate of Analysis) is a formal document that attests to Glatiramer's compliance with Glatiramer specifications and serves as a tool for batch-level quality control.
Glatiramer CoA mostly includes findings from lab analyses of a specific batch. For each Glatiramer 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.
Glatiramer may be tested according to a variety of international standards, such as European Pharmacopoeia (Glatiramer EP), Glatiramer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glatiramer USP).
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