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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a fast-growing, vertically integrated pharmaceutical company headquartered in Hyderabad, committed to operational excellence, quality, and customer service. It manufact...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
With Fermion, start the journey of your innovative API.
About the Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & F...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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...
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
About the Company : JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headq...
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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, Price,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.
PharmaCompass also assists you with knowing the Trazodone Hydrochloride API Price utilized in the formulation of products. Trazodone Hydrochloride API Price is not always fixed or binding as the Trazodone Hydrochloride Price is obtained through a variety of data sources. The Trazodone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Trittico manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trittico, including repackagers and relabelers. The FDA regulates Trittico manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trittico 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 Trittico manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trittico supplier is an individual or a company that provides Trittico active pharmaceutical ingredient (API) or Trittico finished formulations upon request. The Trittico suppliers may include Trittico API manufacturers, exporters, distributors and traders.
click here to find a list of Trittico suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trittico DMF (Drug Master File) is a document detailing the whole manufacturing process of Trittico active pharmaceutical ingredient (API) in detail. Different forms of Trittico DMFs exist exist since differing nations have different regulations, such as Trittico USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trittico DMF submitted to regulatory agencies in the US is known as a USDMF. Trittico USDMF includes data on Trittico's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trittico USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trittico 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 Trittico Drug Master File in Japan (Trittico JDMF) empowers Trittico 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 Trittico JDMF during the approval evaluation for pharmaceutical products. At the time of Trittico 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 Trittico 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 Trittico Drug Master File in Korea (Trittico KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trittico. The MFDS reviews the Trittico KDMF as part of the drug registration process and uses the information provided in the Trittico KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trittico 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 Trittico API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trittico suppliers with KDMF on PharmaCompass.
A Trittico CEP of the European Pharmacopoeia monograph is often referred to as a Trittico Certificate of Suitability (COS). The purpose of a Trittico CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trittico EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trittico to their clients by showing that a Trittico CEP has been issued for it. The manufacturer submits a Trittico CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trittico CEP holder for the record. Additionally, the data presented in the Trittico CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trittico DMF.
A Trittico CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trittico 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 Trittico suppliers with CEP (COS) on PharmaCompass.
A Trittico written confirmation (Trittico WC) is an official document issued by a regulatory agency to a Trittico manufacturer, verifying that the manufacturing facility of a Trittico active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trittico APIs or Trittico finished pharmaceutical products to another nation, regulatory agencies frequently require a Trittico WC (written confirmation) as part of the regulatory process.
click here to find a list of Trittico 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 Trittico as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trittico 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 Trittico 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 Trittico and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trittico NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trittico suppliers with NDC on PharmaCompass.
Trittico 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 Trittico 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 Trittico GMP manufacturer or Trittico GMP API supplier for your needs.
A Trittico CoA (Certificate of Analysis) is a formal document that attests to Trittico's compliance with Trittico specifications and serves as a tool for batch-level quality control.
Trittico CoA mostly includes findings from lab analyses of a specific batch. For each Trittico 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.
Trittico may be tested according to a variety of international standards, such as European Pharmacopoeia (Trittico EP), Trittico JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trittico USP).
