Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Click Us!
JDMF
EU-WC
NDC
KDMF
Inke S.A: APIs manufacturing plant.
KDMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
With Fermion, start the journey of your innovative API.
CEP/COS
NDC
Temad- We think of world-class quality.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
CEP/COS
EU-WC
NDC
KDMF
CN, AU
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
ASMF
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
CEP/COS
NDC
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17122
Submission : 2004-01-29
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19160
Submission : 2006-02-02
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25954
Submission : 2011-10-26
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-01
Pay. Date : 2017-10-18
DMF Number : 32085
Submission : 2017-10-03
Status :
Type : II
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37105
Submission : 2023-03-22
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24541
Submission : 2011-01-07
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21336
Submission : 2008-02-12
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 : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 18341
Submission : 2005-05-09
Status :
Type : II
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Certificate Number : CEP 2014-200 - Rev 01
Status : Valid
Issue Date : 2024-03-15
Type : Chemical
Substance Number : 2541
With Fermion, start the journey of your innovative API.
Certificate Number : CEP 2015-170 - Rev 01
Status : Valid
Issue Date : 2023-10-16
Type : Chemical
Substance Number : 2541
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : CEP 2017-175 - Rev 01
Status : Valid
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 2541
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : R1-CEP 2016-049 - Rev 00
Status : Valid
Issue Date : 2022-07-27
Type : Chemical
Substance Number : 2541
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Certificate Number : CEP 2023-102 - Rev 00
Status : Valid
Issue Date : 2025-03-04
Type : Chemical
Substance Number : 2541
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : R1-CEP 2014-287 - Rev 00
Status : Valid
Issue Date : 2021-03-08
Type : Chemical
Substance Number : 2541
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Certificate Number : R0-CEP 2019-291 - Rev 02
Status : Valid
Issue Date : 2023-07-10
Type : Chemical
Substance Number : 2541
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2017-210 - Rev 04
Status : Valid
Issue Date : 2024-04-17
Type : Chemical
Substance Number : 2541
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2020-234 - Rev 02
Status : Valid
Issue Date : 2023-12-19
Type : Chemical
Substance Number : 2541
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm : Plot No. 3102/B, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat I...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm : Plot No. E-50, 50/1 and 59/1, Unit — IV, MIDC, Tarapur — 401506, Taluka: Pal...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2022-06-22
Valid Till : 2025-05-20
Written Confirmation Number : WC-0001
Address of the Firm : Q-1-4,Industrial area ,Ghinrongi Malanpur -477 117, Dist -Bhind (MP)
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2019-06-17
Valid Till : 2022-05-26
Written Confirmation Number : WC-0002
Address of the Firm : A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Sangjin Corporation
Registration Date : 2012-06-28
Registration Number : 20120628-172-I-86-04
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : Chemical Technical Operations, Unit-VI, APIIC Industrial Estate, Pydibhimavaram, Rana...
Inke S.A: APIs manufacturing plant.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-03-15
Registration Number : 20130315-172-I-248-10
Manufacturer Name : INKE, SA
Manufacturer Address : Area Industrial del Llobregat, C/ Argent, 108755 CASTELLBISBAL, Barcelona, SPAI...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-06-30
Registration Number : 20200630-172-I-573-23
Manufacturer Name : ZCL Chemicals Limited
Manufacturer Address : 3102/B, GIDC Industrial Estate Ankleshwar City : Ankleshwar-393002 Dist : Bharuch, Gu...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registrant Name : Korea Pharma Co., Ltd.
Registration Date : 2015-06-05
Registration Number : 20150605-172-I-456-16
Manufacturer Name : Moehs Cantabra, SL_x000D_
Manufacturer Address : Poligono Industrial Requejada, Polanco 39313 (Cantabria), Spain_x000D_
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2019-06-11
Registration Number : 20150605-172-I-456-16(1)
Manufacturer Name : Moehs Cantabra, SL
Manufacturer Address : Poligono Industrial Requejada, Polanco 39313 (Cantabria), Spain
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
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...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
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...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
About the Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty ch...
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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
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapin XR Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapin XR Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapin XR Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapin XR Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapin XR Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapine XR Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 400mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Quetiapine Zentiva
Dosage Form : Filmtabl
Dosage Strength : 25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number : 77380
Regulatory Info : Generic
Registration Country : Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 90749
Regulatory Info : Generic
Registration Country : Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number : 201762
Regulatory Info : Generic
Registration Country : Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 202152
Regulatory Info : Generic
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.
Regulatory Info : Generic
Registration Country : New Zealand
Brand Name :
Dosage Form : TABLET
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : New Zealand
End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.
Regulatory Info : Generic
Registration Country : New Zealand
Brand Name :
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : New Zealand
End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.
Regulatory Info : Generic
Registration Country : New Zealand
Brand Name :
Dosage Form : TABLET
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : New Zealand
End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.
Regulatory Info : Generic
Registration Country : New Zealand
Brand Name :
Dosage Form : TABLET
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : New Zealand
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Quetiapine Hemifumarat...
Dosage Form : DC Granules
Dosage Strength : 100MG
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 400MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 22047
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PharmaCompass offers a list of Quetiapine Fumarate 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 Quetiapine Fumarate manufacturer or Quetiapine Fumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Quetiapine Fumarate manufacturer or Quetiapine Fumarate supplier.
PharmaCompass also assists you with knowing the Quetiapine Fumarate API Price utilized in the formulation of products. Quetiapine Fumarate API Price is not always fixed or binding as the Quetiapine Fumarate Price is obtained through a variety of data sources. The Quetiapine Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Quetiapine Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quetiapine Fumarate, including repackagers and relabelers. The FDA regulates Quetiapine Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quetiapine Fumarate 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 Quetiapine Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Quetiapine Fumarate supplier is an individual or a company that provides Quetiapine Fumarate active pharmaceutical ingredient (API) or Quetiapine Fumarate finished formulations upon request. The Quetiapine Fumarate suppliers may include Quetiapine Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Quetiapine Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quetiapine Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Quetiapine Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Quetiapine Fumarate DMFs exist exist since differing nations have different regulations, such as Quetiapine Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quetiapine Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Quetiapine Fumarate USDMF includes data on Quetiapine Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quetiapine Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quetiapine Fumarate 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 Quetiapine Fumarate Drug Master File in Japan (Quetiapine Fumarate JDMF) empowers Quetiapine Fumarate 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 Quetiapine Fumarate JDMF during the approval evaluation for pharmaceutical products. At the time of Quetiapine Fumarate 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 Quetiapine Fumarate 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 Quetiapine Fumarate Drug Master File in Korea (Quetiapine Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Quetiapine Fumarate. The MFDS reviews the Quetiapine Fumarate KDMF as part of the drug registration process and uses the information provided in the Quetiapine Fumarate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Quetiapine Fumarate 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 Quetiapine Fumarate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Quetiapine Fumarate suppliers with KDMF on PharmaCompass.
A Quetiapine Fumarate CEP of the European Pharmacopoeia monograph is often referred to as a Quetiapine Fumarate Certificate of Suitability (COS). The purpose of a Quetiapine Fumarate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Quetiapine Fumarate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Quetiapine Fumarate to their clients by showing that a Quetiapine Fumarate CEP has been issued for it. The manufacturer submits a Quetiapine Fumarate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Quetiapine Fumarate CEP holder for the record. Additionally, the data presented in the Quetiapine Fumarate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Quetiapine Fumarate DMF.
A Quetiapine Fumarate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Quetiapine Fumarate 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 Quetiapine Fumarate suppliers with CEP (COS) on PharmaCompass.
A Quetiapine Fumarate written confirmation (Quetiapine Fumarate WC) is an official document issued by a regulatory agency to a Quetiapine Fumarate manufacturer, verifying that the manufacturing facility of a Quetiapine Fumarate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Quetiapine Fumarate APIs or Quetiapine Fumarate finished pharmaceutical products to another nation, regulatory agencies frequently require a Quetiapine Fumarate WC (written confirmation) as part of the regulatory process.
click here to find a list of Quetiapine Fumarate 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 Quetiapine Fumarate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Quetiapine Fumarate 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 Quetiapine Fumarate 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 Quetiapine Fumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Quetiapine Fumarate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Quetiapine Fumarate suppliers with NDC on PharmaCompass.
Quetiapine Fumarate 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 Quetiapine Fumarate 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 Quetiapine Fumarate GMP manufacturer or Quetiapine Fumarate GMP API supplier for your needs.
A Quetiapine Fumarate CoA (Certificate of Analysis) is a formal document that attests to Quetiapine Fumarate's compliance with Quetiapine Fumarate specifications and serves as a tool for batch-level quality control.
Quetiapine Fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Quetiapine Fumarate 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.
Quetiapine Fumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Quetiapine Fumarate EP), Quetiapine Fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quetiapine Fumarate USP).
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