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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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DMF Number : 36655
Submission : 2022-01-08
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Type : II
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DMF Number : 41918
Submission : 2025-05-30
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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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DMF Number : 41491
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DMF Number : 42544
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Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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Date of Issue : 2025-08-05
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Written Confirmation Number : WC-0054
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2025-09-03
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Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
Maithri Drugs: Dedicated to your API needs.
Date of Issue : 2022-11-18
Valid Till : 2025-09-30
Written Confirmation Number : WC-0455
Address of the Firm : Sy No. 14, IDA Gaddapotharam, Gaddapotharam (V), Jinnaram (M), Sangareddy (D), T...
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PharmaCompass offers a list of Brivaracetam 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 Brivaracetam manufacturer or Brivaracetam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Brivaracetam manufacturer or Brivaracetam supplier.
PharmaCompass also assists you with knowing the Brivaracetam API Price utilized in the formulation of products. Brivaracetam API Price is not always fixed or binding as the Brivaracetam Price is obtained through a variety of data sources. The Brivaracetam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide, including repackagers and relabelers. The FDA regulates (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide supplier is an individual or a company that provides (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide active pharmaceutical ingredient (API) or (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide finished formulations upon request. The (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide suppliers may include (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide API manufacturers, exporters, distributors and traders.
click here to find a list of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide DMF (Drug Master File) is a document detailing the whole manufacturing process of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide active pharmaceutical ingredient (API) in detail. Different forms of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide DMFs exist exist since differing nations have different regulations, such as (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide DMF submitted to regulatory agencies in the US is known as a USDMF. (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide USDMF includes data on (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide Drug Master File in Korea ((2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide. The MFDS reviews the (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide KDMF as part of the drug registration process and uses the information provided in the (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide suppliers with KDMF on PharmaCompass.
A (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CEP of the European Pharmacopoeia monograph is often referred to as a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide Certificate of Suitability (COS). The purpose of a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide to their clients by showing that a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CEP has been issued for it. The manufacturer submits a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CEP holder for the record. Additionally, the data presented in the (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide DMF.
A (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide suppliers with CEP (COS) on PharmaCompass.
A (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide written confirmation ((2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide WC) is an official document issued by a regulatory agency to a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide manufacturer, verifying that the manufacturing facility of a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide APIs or (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide finished pharmaceutical products to another nation, regulatory agencies frequently require a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide WC (written confirmation) as part of the regulatory process.
click here to find a list of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide suppliers with NDC on PharmaCompass.
(2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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 (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide GMP manufacturer or (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide GMP API supplier for your needs.
A (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CoA (Certificate of Analysis) is a formal document that attests to (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide's compliance with (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide specifications and serves as a tool for batch-level quality control.
(2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide CoA mostly includes findings from lab analyses of a specific batch. For each (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide 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.
(2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide may be tested according to a variety of international standards, such as European Pharmacopoeia ((2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide EP), (2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide USP).
