Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-06
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034n
Address of the Firm : Plot Nos. 1, 75A, 75B, 105, 110, 111 & 112, Sri Venkateswara Co-operative Indust...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-06
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034Amended
Address of the Firm : Plot Nos. 1, 75A, 75B, 105, 110, 111 & 112, Sri Venkateswara Co-operative Indust...
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 : 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 : 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 : 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...
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...
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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...
Human Pharmalabs manufacturer of high quality corticosteroid APIs with a state of the art facility in Kalol Gandhinagar.
About the Company : Human Pharmalabs Pvt. Ltd. was founded to manufacture lifesaving critical APIs in India, pioneering the introduction of Corticosteroid APIs. The company adheres to international st...
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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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DOSAGE - CAPSULE;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 21319
DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG
USFDA APPLICATION NUMBER - 22460
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule
Grade : Oral
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Tablet
Grade : Oral
Application : Solubilizers
Excipient Details : EUDRAGIT® L 12,5 (organic solution), a delayed release polymer is used to increase solubility of poorly soluble products such as tablets and capsules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid Methyl Methacrylate Copolymer
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Tablet
Grade : Oral
Application : Solubilizers
Excipient Details : EUDRAGIT® S 12,5 (Organic solution) a delayed release polymer, used to increase solubility of poorly soluble drugs such as tablets and capsules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid Methyl Methacrylate Copolymer
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Orodispersible Tablet
Grade : Oral, Topical
Application : Disintegrants & Superdisintegrants
Excipient Details : Glycine is used as a disintegrant in solid dosage forms such as orally disintegrating tablets and in topical formulations such as emulsions & creams.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 75.07 g/mol
Ingredient(s) : Glycine Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
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Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Solubilizers
Film Formers & Plasticizers
Topical
Parenteral
Taste Masking
Direct Compression
Co-Processed Excipients
Granulation
Rheology Modifiers
Empty Capsules
Disintegrants & Superdisintegrants
Emulsifying Agents
Chewable & Orodispersible Aids
Surfactant & Foaming Agents
Coloring Agents
Lubricants & Glidants
Vegetarian Capsules
API Stability Enhancers
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
61
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 Avodart manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avodart, including repackagers and relabelers. The FDA regulates Avodart manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avodart 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 Avodart manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avodart supplier is an individual or a company that provides Avodart active pharmaceutical ingredient (API) or Avodart finished formulations upon request. The Avodart suppliers may include Avodart API manufacturers, exporters, distributors and traders.
click here to find a list of Avodart suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Avodart DMF (Drug Master File) is a document detailing the whole manufacturing process of Avodart active pharmaceutical ingredient (API) in detail. Different forms of Avodart DMFs exist exist since differing nations have different regulations, such as Avodart USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Avodart DMF submitted to regulatory agencies in the US is known as a USDMF. Avodart USDMF includes data on Avodart's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Avodart USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Avodart 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 Avodart Drug Master File in Japan (Avodart JDMF) empowers Avodart 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 Avodart JDMF during the approval evaluation for pharmaceutical products. At the time of Avodart 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 Avodart 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 Avodart Drug Master File in Korea (Avodart KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Avodart. The MFDS reviews the Avodart KDMF as part of the drug registration process and uses the information provided in the Avodart KDMF to evaluate the safety and efficacy of the drug.
After submitting a Avodart 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 Avodart API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Avodart suppliers with KDMF on PharmaCompass.
A Avodart CEP of the European Pharmacopoeia monograph is often referred to as a Avodart Certificate of Suitability (COS). The purpose of a Avodart CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Avodart EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Avodart to their clients by showing that a Avodart CEP has been issued for it. The manufacturer submits a Avodart CEP (COS) as part of the market authorization procedure, and it takes on the role of a Avodart CEP holder for the record. Additionally, the data presented in the Avodart CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Avodart DMF.
A Avodart CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Avodart 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 Avodart suppliers with CEP (COS) on PharmaCompass.
A Avodart written confirmation (Avodart WC) is an official document issued by a regulatory agency to a Avodart manufacturer, verifying that the manufacturing facility of a Avodart active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Avodart APIs or Avodart finished pharmaceutical products to another nation, regulatory agencies frequently require a Avodart WC (written confirmation) as part of the regulatory process.
click here to find a list of Avodart 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 Avodart as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Avodart 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 Avodart 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 Avodart and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Avodart NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Avodart suppliers with NDC on PharmaCompass.
Avodart 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 Avodart 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 Avodart GMP manufacturer or Avodart GMP API supplier for your needs.
A Avodart CoA (Certificate of Analysis) is a formal document that attests to Avodart's compliance with Avodart specifications and serves as a tool for batch-level quality control.
Avodart CoA mostly includes findings from lab analyses of a specific batch. For each Avodart 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.
Avodart may be tested according to a variety of international standards, such as European Pharmacopoeia (Avodart EP), Avodart JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Avodart USP).
