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DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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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 : 2013-08-12
Pay. Date : 2012-11-30
DMF Number : 26475
Submission : 2012-10-03
Status :
Type : II
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-15
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034
Address of the Firm : Chemical Technical Operations-Unit II, Plot Nos. 1, 75A, 75B, 105, 110, 111 & 1...
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 : 2010-12-30
Registration Number : No. 4692-3-ND
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...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : EQ Bio Co., Ltd.
Registration Date : 2024-10-25
Registration Number : No. 4692-3-ND(3)
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...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : JDW Pharmaceutical Co., Ltd.
Registration Date : 2018-08-14
Registration Number : No. 4692-3-ND(2)
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...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : YuYu Pharmaceutical Co., Ltd.
Registration Date : 2011-09-02
Registration Number : No. 4692-3-ND(1)
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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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, ...
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...
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...
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...
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...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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DOSAGE - CAPSULE;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 21319
DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG
USFDA APPLICATION NUMBER - 22460
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Digital Content
NEWS #PharmaBuzz
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US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
64
PharmaCompass offers a list of Dutasteride 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 Dutasteride manufacturer or Dutasteride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dutasteride manufacturer or Dutasteride supplier.
PharmaCompass also assists you with knowing the Dutasteride API Price utilized in the formulation of products. Dutasteride API Price is not always fixed or binding as the Dutasteride Price is obtained through a variety of data sources. The Dutasteride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE supplier is an individual or a company that provides DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE active pharmaceutical ingredient (API) or DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE finished formulations upon request. The DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE suppliers may include DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE USDMF includes data on DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Drug Master File in Japan (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE JDMF) empowers DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE JDMF during the approval evaluation for pharmaceutical products. At the time of DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Drug Master File in Korea (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE. The MFDS reviews the DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE KDMF as part of the drug registration process and uses the information provided in the DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE KDMF to evaluate the safety and efficacy of the drug.
After submitting a DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE suppliers with KDMF on PharmaCompass.
A DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CEP of the European Pharmacopoeia monograph is often referred to as a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Certificate of Suitability (COS). The purpose of a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE to their clients by showing that a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CEP has been issued for it. The manufacturer submits a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CEP (COS) as part of the market authorization procedure, and it takes on the role of a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CEP holder for the record. Additionally, the data presented in the DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE DMF.
A DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE suppliers with CEP (COS) on PharmaCompass.
A DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE written confirmation (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE WC) is an official document issued by a regulatory agency to a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE manufacturer, verifying that the manufacturing facility of a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE APIs or DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE finished pharmaceutical products to another nation, regulatory agencies frequently require a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE WC (written confirmation) as part of the regulatory process.
click here to find a list of DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE suppliers with NDC on PharmaCompass.
DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN 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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE GMP manufacturer or DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE GMP API supplier for your needs.
A DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CoA (Certificate of Analysis) is a formal document that attests to DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE's compliance with DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE specifications and serves as a tool for batch-level quality control.
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each DUTASTERIDE AND TAMSULOSIN 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.
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE may be tested according to a variety of international standards, such as European Pharmacopoeia (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE EP), DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE USP).
