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JDMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2013-04-10
DMF Number : 19599
Submission : 2006-07-14
Status :
Type : II
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Certificate Number : R1-CEP 2015-301 - Rev 01
Status : Valid
Issue Date : 2022-07-18
Type : Chemical
Substance Number : 2781
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Certificate Number : R1-CEP 2015-192 - Rev 00
Status : Valid
Issue Date : 2021-08-30
Type : Chemical
Substance Number : 2781
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Maithri Drugs: Dedicated to your API needs.
Date of Issue : 2026-02-24
Valid Till : 2029-02-23
Written Confirmation Number : WC-0455
Address of the Firm : Sy No. 14, IDA Gaddapotharam, Gaddapotharam (V), Jinnaram (M), Sangareddy (D), T...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2020-07-14
Registration Number : 20200714-209-J-584
Manufacturer Name : Interquim, SA
Manufacturer Address : c/ Joan Buscallà, 10, 08173 Sant Cugat Del Vallès (Barcelona), Spain
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2020-11-06
Registration Number : 20200714-209-J-584(1)
Manufacturer Name : Interquim, SA
Manufacturer Address : c/ Joan Buscallà, 10, 08173 Sant Cugat Del Vallès (Barcelona), Spain
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978 and part of Ferrer HealthTech, develops high-value APIs with strict quality standards. Its facilities comply with European regulations, and products are ...
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
About the Company : Pharmathen, established in 1969, has emerged as a leading in-house development partner in Europe. It specializes in the development, registration, manufacturing & life-cycle manage...
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 legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 20771
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 20771
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2MG
USFDA APPLICATION NUMBER - 21228
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 4MG
USFDA APPLICATION NUMBER - 21228
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Tolterodine Tartrate 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 Tolterodine Tartrate manufacturer or Tolterodine Tartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tolterodine Tartrate manufacturer or Tolterodine Tartrate supplier.
A Urotrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urotrol, including repackagers and relabelers. The FDA regulates Urotrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urotrol 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 Urotrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Urotrol supplier is an individual or a company that provides Urotrol active pharmaceutical ingredient (API) or Urotrol finished formulations upon request. The Urotrol suppliers may include Urotrol API manufacturers, exporters, distributors and traders.
click here to find a list of Urotrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Urotrol DMF (Drug Master File) is a document detailing the whole manufacturing process of Urotrol active pharmaceutical ingredient (API) in detail. Different forms of Urotrol DMFs exist exist since differing nations have different regulations, such as Urotrol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urotrol DMF submitted to regulatory agencies in the US is known as a USDMF. Urotrol USDMF includes data on Urotrol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urotrol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urotrol suppliers with USDMF 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 Urotrol Drug Master File in Korea (Urotrol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Urotrol. The MFDS reviews the Urotrol KDMF as part of the drug registration process and uses the information provided in the Urotrol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Urotrol 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 Urotrol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Urotrol suppliers with KDMF on PharmaCompass.
A Urotrol CEP of the European Pharmacopoeia monograph is often referred to as a Urotrol Certificate of Suitability (COS). The purpose of a Urotrol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Urotrol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Urotrol to their clients by showing that a Urotrol CEP has been issued for it. The manufacturer submits a Urotrol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Urotrol CEP holder for the record. Additionally, the data presented in the Urotrol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Urotrol DMF.
A Urotrol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Urotrol 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 Urotrol suppliers with CEP (COS) on PharmaCompass.
A Urotrol written confirmation (Urotrol WC) is an official document issued by a regulatory agency to a Urotrol manufacturer, verifying that the manufacturing facility of a Urotrol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Urotrol APIs or Urotrol finished pharmaceutical products to another nation, regulatory agencies frequently require a Urotrol WC (written confirmation) as part of the regulatory process.
click here to find a list of Urotrol 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 Urotrol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Urotrol 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 Urotrol 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 Urotrol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Urotrol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Urotrol suppliers with NDC on PharmaCompass.
Urotrol 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 Urotrol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Urotrol GMP manufacturer or Urotrol GMP API supplier for your needs.
A Urotrol CoA (Certificate of Analysis) is a formal document that attests to Urotrol's compliance with Urotrol specifications and serves as a tool for batch-level quality control.
Urotrol CoA mostly includes findings from lab analyses of a specific batch. For each Urotrol 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.
Urotrol may be tested according to a variety of international standards, such as European Pharmacopoeia (Urotrol EP), Urotrol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Urotrol USP).
