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USDMF
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29207
Submission : 2015-08-12
Status :
Type : II
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-06
Pay. Date : 2014-07-15
DMF Number : 28458
Submission : 2014-09-16
Status :
Type : II
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28340
Submission : 2016-08-15
Status :
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-16
Pay. Date : 2016-09-20
DMF Number : 30861
Submission : 2016-09-27
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2016-11-25
DMF Number : 31145
Submission : 2016-12-09
Status :
Type : II
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Chirogate is a professional Prostaglandin manufacturer.
About the Company : Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. Focused on quality and compliance, it offers competitively priced p...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
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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PharmaCompass offers a list of Treprostinil Sodium 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 Treprostinil Sodium manufacturer or Treprostinil Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Treprostinil Sodium manufacturer or Treprostinil Sodium supplier.
PharmaCompass also assists you with knowing the Treprostinil Sodium API Price utilized in the formulation of products. Treprostinil Sodium API Price is not always fixed or binding as the Treprostinil Sodium Price is obtained through a variety of data sources. The Treprostinil Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Uniprost manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Uniprost, including repackagers and relabelers. The FDA regulates Uniprost manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Uniprost 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 Uniprost manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Uniprost supplier is an individual or a company that provides Uniprost active pharmaceutical ingredient (API) or Uniprost finished formulations upon request. The Uniprost suppliers may include Uniprost API manufacturers, exporters, distributors and traders.
click here to find a list of Uniprost suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Uniprost DMF (Drug Master File) is a document detailing the whole manufacturing process of Uniprost active pharmaceutical ingredient (API) in detail. Different forms of Uniprost DMFs exist exist since differing nations have different regulations, such as Uniprost USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Uniprost DMF submitted to regulatory agencies in the US is known as a USDMF. Uniprost USDMF includes data on Uniprost's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Uniprost USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Uniprost 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 Uniprost Drug Master File in Korea (Uniprost KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Uniprost. The MFDS reviews the Uniprost KDMF as part of the drug registration process and uses the information provided in the Uniprost KDMF to evaluate the safety and efficacy of the drug.
After submitting a Uniprost 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 Uniprost API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Uniprost suppliers with KDMF on PharmaCompass.
A Uniprost written confirmation (Uniprost WC) is an official document issued by a regulatory agency to a Uniprost manufacturer, verifying that the manufacturing facility of a Uniprost active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Uniprost APIs or Uniprost finished pharmaceutical products to another nation, regulatory agencies frequently require a Uniprost WC (written confirmation) as part of the regulatory process.
click here to find a list of Uniprost 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 Uniprost as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Uniprost 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 Uniprost 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 Uniprost and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Uniprost NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Uniprost suppliers with NDC on PharmaCompass.
Uniprost 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 Uniprost 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 Uniprost GMP manufacturer or Uniprost GMP API supplier for your needs.
A Uniprost CoA (Certificate of Analysis) is a formal document that attests to Uniprost's compliance with Uniprost specifications and serves as a tool for batch-level quality control.
Uniprost CoA mostly includes findings from lab analyses of a specific batch. For each Uniprost 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.
Uniprost may be tested according to a variety of international standards, such as European Pharmacopoeia (Uniprost EP), Uniprost JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Uniprost USP).
