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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
1-(3-chlorophenyl)-4-(3-chloropropyl) piperazine, ...
CAS Number : 52605-52-4
End Use API : Trazodone Hydrochloride
About The Company : PMC Isochem, acquired by PMC International in 2017, is a CDMO manufacturing cGMP intermediates, APIs, and functional excipients for global pharmaceutical and pe...
Rampex Labs – Simplifying Synthesis with Innovation, Quality, and Commitment to Global Pharmaceutical Excellence.
1-(3-Chlorophenyl) Piperazine Hydrochloride
CAS Number : 13078-15-4
End Use API : Trazodone Hydrochloride
About The Company : Rampex Labs, founded in 2004, is a fully cGMP-compliant pharmaceutical manufacturer with two USFDA-approved facilities in Hyderabad and Vizag, India. The Hydera...
Rampex Labs – Simplifying Synthesis with Innovation, Quality, and Commitment to Global Pharmaceutical Excellence.
1,2,4-Triazolo[4,3-A]Pyridin-3(2H)-One, Sodium Sal...
CAS Number : 50594-92-8
End Use API : Trazodone Hydrochloride
About The Company : Rampex Labs, founded in 2004, is a fully cGMP-compliant pharmaceutical manufacturer with two USFDA-approved facilities in Hyderabad and Vizag, India. The Hydera...
Saiming Pharmaceutical – Delivering innovative, sustainable chemical solutions with global reach and 12+ years of trusted excellence.
CAS Number : 554-00-7
End Use API : Trazodone Hydrochloride
About The Company : Saiming Pharmaceutical is a technology-driven company with 12+ years of experience. Our business involves the R&D, production, and trading of pharmaceutical int...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Trazodone Hydrochloride 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 Trazodone Hydrochloride manufacturer or Trazodone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trazodone Hydrochloride manufacturer or Trazodone Hydrochloride supplier.
A Trazodon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trazodon, including repackagers and relabelers. The FDA regulates Trazodon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trazodon 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 Trazodon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Trazodon supplier is an individual or a company that provides Trazodon active pharmaceutical ingredient (API) or Trazodon finished formulations upon request. The Trazodon suppliers may include Trazodon API manufacturers, exporters, distributors and traders.
click here to find a list of Trazodon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Trazodon DMF (Drug Master File) is a document detailing the whole manufacturing process of Trazodon active pharmaceutical ingredient (API) in detail. Different forms of Trazodon DMFs exist exist since differing nations have different regulations, such as Trazodon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trazodon DMF submitted to regulatory agencies in the US is known as a USDMF. Trazodon USDMF includes data on Trazodon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trazodon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trazodon 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 Trazodon Drug Master File in Japan (Trazodon JDMF) empowers Trazodon 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 Trazodon JDMF during the approval evaluation for pharmaceutical products. At the time of Trazodon 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 Trazodon 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 Trazodon Drug Master File in Korea (Trazodon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trazodon. The MFDS reviews the Trazodon KDMF as part of the drug registration process and uses the information provided in the Trazodon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trazodon 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 Trazodon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trazodon suppliers with KDMF on PharmaCompass.
A Trazodon CEP of the European Pharmacopoeia monograph is often referred to as a Trazodon Certificate of Suitability (COS). The purpose of a Trazodon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trazodon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trazodon to their clients by showing that a Trazodon CEP has been issued for it. The manufacturer submits a Trazodon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trazodon CEP holder for the record. Additionally, the data presented in the Trazodon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trazodon DMF.
A Trazodon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trazodon 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 Trazodon suppliers with CEP (COS) on PharmaCompass.
A Trazodon written confirmation (Trazodon WC) is an official document issued by a regulatory agency to a Trazodon manufacturer, verifying that the manufacturing facility of a Trazodon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trazodon APIs or Trazodon finished pharmaceutical products to another nation, regulatory agencies frequently require a Trazodon WC (written confirmation) as part of the regulatory process.
click here to find a list of Trazodon suppliers with Written Confirmation (WC) 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 Trazodon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trazodon 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 Trazodon 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 Trazodon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trazodon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trazodon suppliers with NDC on PharmaCompass.
Trazodon 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 Trazodon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Trazodon GMP manufacturer or Trazodon GMP API supplier for your needs.
A Trazodon CoA (Certificate of Analysis) is a formal document that attests to Trazodon's compliance with Trazodon specifications and serves as a tool for batch-level quality control.
Trazodon CoA mostly includes findings from lab analyses of a specific batch. For each Trazodon 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.
Trazodon may be tested according to a variety of international standards, such as European Pharmacopoeia (Trazodon EP), Trazodon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trazodon USP).
