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API SUPPLIERS
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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ASMF, CN
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
EU-WC
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Trazodone Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Gains ANDA approval for Trazodone Tablets
Details : Desyrel-Generic (trazodone hydrochloride) is a selective serotonin reuptake inhibitor indicated for the treatment of patients with major depressive disorder.
Product Name : Desyrel-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 09, 2024
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Immediate Release Tabl...
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Immediate Release Tabl...
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Immediate Release Tabl...
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Immediate Release Tabl...
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : ROW
Registration Country : India
Brand Name : Trazodone
Dosage Form : Tablet
Dosage Strength : 34.88%
Packaging :
Approval Date :
Application Number :
Regulatory Info : ROW
Registration Country : India
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Sustained Release Tabl...
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Sustained Release Tabl...
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Trazodone Hydrochlorid...
Dosage Form : Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Coating Systems & Additives
Direct Compression
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking
Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Granulation
Controlled & Modified Release
Thickeners and Stabilizers
Solubilizers
Disintegrants & Superdisintegrants
Lubricants & Glidants
Topical
Co-Processed Excipients
Parenteral
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Taste Masking
Emulsifying Agents
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Rheology Modifiers
Empty Capsules
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Digital Content
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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 Tritico manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tritico, including repackagers and relabelers. The FDA regulates Tritico manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tritico 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 Tritico manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tritico supplier is an individual or a company that provides Tritico active pharmaceutical ingredient (API) or Tritico finished formulations upon request. The Tritico suppliers may include Tritico API manufacturers, exporters, distributors and traders.
click here to find a list of Tritico suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tritico DMF (Drug Master File) is a document detailing the whole manufacturing process of Tritico active pharmaceutical ingredient (API) in detail. Different forms of Tritico DMFs exist exist since differing nations have different regulations, such as Tritico USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tritico DMF submitted to regulatory agencies in the US is known as a USDMF. Tritico USDMF includes data on Tritico's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tritico USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tritico 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 Tritico Drug Master File in Japan (Tritico JDMF) empowers Tritico 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 Tritico JDMF during the approval evaluation for pharmaceutical products. At the time of Tritico 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 Tritico 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 Tritico Drug Master File in Korea (Tritico KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tritico. The MFDS reviews the Tritico KDMF as part of the drug registration process and uses the information provided in the Tritico KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tritico 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 Tritico API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tritico suppliers with KDMF on PharmaCompass.
A Tritico CEP of the European Pharmacopoeia monograph is often referred to as a Tritico Certificate of Suitability (COS). The purpose of a Tritico CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tritico EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tritico to their clients by showing that a Tritico CEP has been issued for it. The manufacturer submits a Tritico CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tritico CEP holder for the record. Additionally, the data presented in the Tritico CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tritico DMF.
A Tritico CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tritico 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 Tritico suppliers with CEP (COS) on PharmaCompass.
A Tritico written confirmation (Tritico WC) is an official document issued by a regulatory agency to a Tritico manufacturer, verifying that the manufacturing facility of a Tritico active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tritico APIs or Tritico finished pharmaceutical products to another nation, regulatory agencies frequently require a Tritico WC (written confirmation) as part of the regulatory process.
click here to find a list of Tritico 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 Tritico as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tritico 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 Tritico 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 Tritico and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tritico NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tritico suppliers with NDC on PharmaCompass.
Tritico 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 Tritico 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 Tritico GMP manufacturer or Tritico GMP API supplier for your needs.
A Tritico CoA (Certificate of Analysis) is a formal document that attests to Tritico's compliance with Tritico specifications and serves as a tool for batch-level quality control.
Tritico CoA mostly includes findings from lab analyses of a specific batch. For each Tritico 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.
Tritico may be tested according to a variety of international standards, such as European Pharmacopoeia (Tritico EP), Tritico JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tritico USP).
