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API SUPPLIERS
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-02
Pay. Date : 2013-03-22
DMF Number : 16143
Submission : 2002-09-23
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 : 2014-04-29
Pay. Date : 2014-02-24
DMF Number : 27969
Submission : 2014-03-17
Status :
Type : II
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Certificate Number : R1-CEP 2014-054 - Rev 01
Status : Valid
Issue Date : 2023-03-31
Type : Chemical
Substance Number : 2375
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2020-09-17
Registration Number : 20200917-209-J-745
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...
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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...
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...
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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
4-(2-Piperidinoethoxy)benzoyl chloride, HCl
CAS Number : 84449-81-0
End Use API : Raloxifene Hydrochloride
About The Company : PMC Isochem, acquired by PMC International in 2017, is a CDMO manufacturing cGMP intermediates, APIs, and functional excipients for global pharmaceutical and pe...
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ANALYTICAL
ABOUT THIS PAGE
96
PharmaCompass offers a list of Raloxifene Hydrochloride 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 Raloxifene Hydrochloride manufacturer or Raloxifene Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Raloxifene Hydrochloride manufacturer or Raloxifene Hydrochloride supplier.
A Raloxifene HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Raloxifene HCl, including repackagers and relabelers. The FDA regulates Raloxifene HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Raloxifene HCl 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 Raloxifene HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Raloxifene HCl supplier is an individual or a company that provides Raloxifene HCl active pharmaceutical ingredient (API) or Raloxifene HCl finished formulations upon request. The Raloxifene HCl suppliers may include Raloxifene HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Raloxifene HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Raloxifene HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Raloxifene HCl active pharmaceutical ingredient (API) in detail. Different forms of Raloxifene HCl DMFs exist exist since differing nations have different regulations, such as Raloxifene HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Raloxifene HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Raloxifene HCl USDMF includes data on Raloxifene HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Raloxifene HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Raloxifene HCl 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 Raloxifene HCl Drug Master File in Japan (Raloxifene HCl JDMF) empowers Raloxifene HCl 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 Raloxifene HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Raloxifene HCl 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 Raloxifene HCl 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 Raloxifene HCl Drug Master File in Korea (Raloxifene HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Raloxifene HCl. The MFDS reviews the Raloxifene HCl KDMF as part of the drug registration process and uses the information provided in the Raloxifene HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Raloxifene HCl 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 Raloxifene HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Raloxifene HCl suppliers with KDMF on PharmaCompass.
A Raloxifene HCl CEP of the European Pharmacopoeia monograph is often referred to as a Raloxifene HCl Certificate of Suitability (COS). The purpose of a Raloxifene HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Raloxifene HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Raloxifene HCl to their clients by showing that a Raloxifene HCl CEP has been issued for it. The manufacturer submits a Raloxifene HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Raloxifene HCl CEP holder for the record. Additionally, the data presented in the Raloxifene HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Raloxifene HCl DMF.
A Raloxifene HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Raloxifene HCl 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 Raloxifene HCl suppliers with CEP (COS) on PharmaCompass.
A Raloxifene HCl written confirmation (Raloxifene HCl WC) is an official document issued by a regulatory agency to a Raloxifene HCl manufacturer, verifying that the manufacturing facility of a Raloxifene HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Raloxifene HCl APIs or Raloxifene HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Raloxifene HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Raloxifene HCl 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 Raloxifene HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Raloxifene HCl 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 Raloxifene HCl 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 Raloxifene HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Raloxifene HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Raloxifene HCl suppliers with NDC on PharmaCompass.
Raloxifene HCl 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 Raloxifene HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Raloxifene HCl GMP manufacturer or Raloxifene HCl GMP API supplier for your needs.
A Raloxifene HCl CoA (Certificate of Analysis) is a formal document that attests to Raloxifene HCl's compliance with Raloxifene HCl specifications and serves as a tool for batch-level quality control.
Raloxifene HCl CoA mostly includes findings from lab analyses of a specific batch. For each Raloxifene HCl 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.
Raloxifene HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Raloxifene HCl EP), Raloxifene HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Raloxifene HCl USP).
