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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
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 : 21327
Submission : 2008-02-11
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.
Raloxifene Hydrochloride USP/Ph. Eur.
Date of Issue : 2025-07-25
Valid Till : 2028-06-16
Written Confirmation Number : WC-0034
Address of the Firm : Unit II, Plot Nos. 1, 75A, 75B, 105, 110, 111 & 112, Sri Venkateswara Co-operati...
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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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ABOUT THIS PAGE
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PharmaCompass offers a list of Raloxifene 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 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.
PharmaCompass also assists you with knowing the Raloxifene Hydrochloride API Price utilized in the formulation of products. Raloxifene Hydrochloride API Price is not always fixed or binding as the Raloxifene Hydrochloride Price is obtained through a variety of data sources. The Raloxifene Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Raloxifene Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Raloxifene Hydrochloride, including repackagers and relabelers. The FDA regulates Raloxifene Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Raloxifene Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Raloxifene Hydrochloride supplier is an individual or a company that provides Raloxifene Hydrochloride active pharmaceutical ingredient (API) or Raloxifene Hydrochloride finished formulations upon request. The Raloxifene Hydrochloride suppliers may include Raloxifene Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Raloxifene Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Raloxifene Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Raloxifene Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Raloxifene Hydrochloride DMFs exist exist since differing nations have different regulations, such as Raloxifene Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Raloxifene Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Raloxifene Hydrochloride USDMF includes data on Raloxifene Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Raloxifene Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Raloxifene Hydrochloride 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 Hydrochloride Drug Master File in Japan (Raloxifene Hydrochloride JDMF) empowers Raloxifene Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Raloxifene Hydrochloride 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 Hydrochloride 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 Hydrochloride Drug Master File in Korea (Raloxifene Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Raloxifene Hydrochloride. The MFDS reviews the Raloxifene Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Raloxifene Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Raloxifene Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Raloxifene Hydrochloride suppliers with KDMF on PharmaCompass.
A Raloxifene Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Raloxifene Hydrochloride Certificate of Suitability (COS). The purpose of a Raloxifene Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Raloxifene Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Raloxifene Hydrochloride to their clients by showing that a Raloxifene Hydrochloride CEP has been issued for it. The manufacturer submits a Raloxifene Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Raloxifene Hydrochloride CEP holder for the record. Additionally, the data presented in the Raloxifene Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Raloxifene Hydrochloride DMF.
A Raloxifene Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Raloxifene Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Raloxifene Hydrochloride written confirmation (Raloxifene Hydrochloride WC) is an official document issued by a regulatory agency to a Raloxifene Hydrochloride manufacturer, verifying that the manufacturing facility of a Raloxifene Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Raloxifene Hydrochloride APIs or Raloxifene Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Raloxifene Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Raloxifene Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Raloxifene Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Raloxifene Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Raloxifene Hydrochloride suppliers with NDC on PharmaCompass.
Raloxifene Hydrochloride 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 Hydrochloride 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 Raloxifene Hydrochloride GMP manufacturer or Raloxifene Hydrochloride GMP API supplier for your needs.
A Raloxifene Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Raloxifene Hydrochloride's compliance with Raloxifene Hydrochloride specifications and serves as a tool for batch-level quality control.
Raloxifene Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Raloxifene Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Raloxifene Hydrochloride EP), Raloxifene Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Raloxifene Hydrochloride USP).
