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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
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SPI Pharma
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tetrahydrozoline 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 Tetrahydrozoline manufacturer or Tetrahydrozoline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tetrahydrozoline manufacturer or Tetrahydrozoline supplier.
A Optigene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Optigene, including repackagers and relabelers. The FDA regulates Optigene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Optigene 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 Optigene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Optigene supplier is an individual or a company that provides Optigene active pharmaceutical ingredient (API) or Optigene finished formulations upon request. The Optigene suppliers may include Optigene API manufacturers, exporters, distributors and traders.
click here to find a list of Optigene suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Optigene DMF (Drug Master File) is a document detailing the whole manufacturing process of Optigene active pharmaceutical ingredient (API) in detail. Different forms of Optigene DMFs exist exist since differing nations have different regulations, such as Optigene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Optigene DMF submitted to regulatory agencies in the US is known as a USDMF. Optigene USDMF includes data on Optigene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Optigene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Optigene 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 Optigene Drug Master File in Japan (Optigene JDMF) empowers Optigene 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 Optigene JDMF during the approval evaluation for pharmaceutical products. At the time of Optigene 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 Optigene 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 Optigene Drug Master File in Korea (Optigene KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Optigene. The MFDS reviews the Optigene KDMF as part of the drug registration process and uses the information provided in the Optigene KDMF to evaluate the safety and efficacy of the drug.
After submitting a Optigene 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 Optigene API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Optigene suppliers with KDMF on PharmaCompass.
A Optigene CEP of the European Pharmacopoeia monograph is often referred to as a Optigene Certificate of Suitability (COS). The purpose of a Optigene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Optigene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Optigene to their clients by showing that a Optigene CEP has been issued for it. The manufacturer submits a Optigene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Optigene CEP holder for the record. Additionally, the data presented in the Optigene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Optigene DMF.
A Optigene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Optigene 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 Optigene 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 Optigene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Optigene 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 Optigene 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 Optigene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Optigene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Optigene suppliers with NDC on PharmaCompass.
Optigene 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 Optigene GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Optigene GMP manufacturer or Optigene GMP API supplier for your needs.
A Optigene CoA (Certificate of Analysis) is a formal document that attests to Optigene's compliance with Optigene specifications and serves as a tool for batch-level quality control.
Optigene CoA mostly includes findings from lab analyses of a specific batch. For each Optigene 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.
Optigene may be tested according to a variety of international standards, such as European Pharmacopoeia (Optigene EP), Optigene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Optigene USP).
