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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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EU-WC
NDC
ASMF, CN
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
With Fermion, start the journey of your innovative API.
ASMF
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - 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.
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USDMF
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-22
Pay. Date : 2023-07-17
DMF Number : 37593
Submission : 2022-12-28
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4570
Submission : 1982-05-21
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-13
DMF Number : 16459
Submission : 2003-03-10
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7459
Submission : 1988-05-05
Status :
Type : II
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : CEP 2023-010 - Rev 00
Status : Valid
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 2857
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Trazodone Hydrochloride IH/USP
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm : Plot No-8, Jawaharlal Nehru Pharamacity,Tadi (v), Parawada (M), Vishakapatnam Di...
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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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API Imports and Exports
Drugs in Development
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SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DKSH
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Application : Emulsifying Agents
Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral, Topical
Application : Rheology Modifiers
Excipient Details : HPMC 60HD4000 is used as thickener and viscosity modifier in oral solid, liquid and topical dosage forms.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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Coating Systems & Additives
Controlled & Modified Release
Direct Compression
Granulation
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Solubilizers
Disintegrants & Superdisintegrants
Lubricants & Glidants
Topical
Co-Processed Excipients
Film Formers & Plasticizers
Taste Masking
Parenteral
Emulsifying Agents
Chewable & Orodispersible Aids
API Stability Enhancers
Rheology Modifiers
Empty Capsules
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Vegetarian Capsules
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Digital Content
DATA COMPILATION #PharmaFlow
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US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
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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).
