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API SUPPLIERS
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USDMF
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
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
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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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm : Plot No. 111, SIDCO Industrial Estate, Kakkalur, Thiruvallur 602 003, Tamil Nadu...
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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. With a focus on quality and compliance, Chirogate has built a reput...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
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, ...
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 leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Treprostinil Reddy
Dosage Form : Infusion Solution
Dosage Strength : 1mg/ml
Packaging :
Approval Date : 26/01/2022
Application Number : 20200930000055
Regulatory Info : Approved
Registration Country : Sweden
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Treprostinil Reddy
Dosage Form : Infusion Solution
Dosage Strength : 10mg/ml
Packaging :
Approval Date : 26/01/2022
Application Number : 20200930000086
Regulatory Info : Approved
Registration Country : Sweden
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Treprostinil Reddy
Dosage Form : Infusion Solution
Dosage Strength : 2.5mg/ml
Packaging :
Approval Date : 26/01/2022
Application Number : 20200930000062
Regulatory Info : Approved
Registration Country : Sweden
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Treprostinil Reddy
Dosage Form : Infusion Solution
Dosage Strength :
Packaging :
Approval Date : 26/01/2022
Application Number : 20200930000079
Regulatory Info : Approved
Registration Country : Sweden
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Evonik
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
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Parenteral
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Film Formers & Plasticizers
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44
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 Treprostinil Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Treprostinil Sodium, including repackagers and relabelers. The FDA regulates Treprostinil Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Treprostinil Sodium 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 Treprostinil Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Treprostinil Sodium supplier is an individual or a company that provides Treprostinil Sodium active pharmaceutical ingredient (API) or Treprostinil Sodium finished formulations upon request. The Treprostinil Sodium suppliers may include Treprostinil Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Treprostinil Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Treprostinil Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Treprostinil Sodium active pharmaceutical ingredient (API) in detail. Different forms of Treprostinil Sodium DMFs exist exist since differing nations have different regulations, such as Treprostinil Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Treprostinil Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Treprostinil Sodium USDMF includes data on Treprostinil Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Treprostinil Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Treprostinil Sodium 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 Treprostinil Sodium Drug Master File in Korea (Treprostinil Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Treprostinil Sodium. The MFDS reviews the Treprostinil Sodium KDMF as part of the drug registration process and uses the information provided in the Treprostinil Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Treprostinil Sodium 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 Treprostinil Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Treprostinil Sodium suppliers with KDMF on PharmaCompass.
A Treprostinil Sodium written confirmation (Treprostinil Sodium WC) is an official document issued by a regulatory agency to a Treprostinil Sodium manufacturer, verifying that the manufacturing facility of a Treprostinil Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Treprostinil Sodium APIs or Treprostinil Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Treprostinil Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Treprostinil Sodium 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 Treprostinil Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Treprostinil Sodium 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 Treprostinil Sodium 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 Treprostinil Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Treprostinil Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Treprostinil Sodium suppliers with NDC on PharmaCompass.
Treprostinil Sodium 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 Treprostinil Sodium 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 Treprostinil Sodium GMP manufacturer or Treprostinil Sodium GMP API supplier for your needs.
A Treprostinil Sodium CoA (Certificate of Analysis) is a formal document that attests to Treprostinil Sodium's compliance with Treprostinil Sodium specifications and serves as a tool for batch-level quality control.
Treprostinil Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Treprostinil Sodium 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.
Treprostinil Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Treprostinil Sodium EP), Treprostinil Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Treprostinil Sodium USP).
