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API SUPPLIERS
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USDMF
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Temad- We think of world-class quality.
Japanese Pharmacopoeia Noscapine
Registration Number : 219MF10150
Registrant's Address : 28th Km of Karaj Makhsous Road, Tehran, Iran
Initial Date of Registration : 2007-04-27
Latest Date of Registration : 2007-04-27
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Temad- We think of world-class quality.
Date of Issue : 2019-01-02
Valid Till : 2021-01-02
Written Confirmation Number : 665/93729
Address of the Firm : 28th km of Karaj Makhsous Road, Tehran, Iran
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
Date of Issue : 2024-05-22
Valid Till : 2027-07-02
Written Confirmation Number : WC-0301
Address of the Firm : Plot No. 60A, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District...
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Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
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 ...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
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PharmaCompass offers a list of Noscapine 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 Noscapine manufacturer or Noscapine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Noscapine manufacturer or Noscapine supplier.
PharmaCompass also assists you with knowing the Noscapine API Price utilized in the formulation of products. Noscapine API Price is not always fixed or binding as the Noscapine Price is obtained through a variety of data sources. The Noscapine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Capval manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Capval, including repackagers and relabelers. The FDA regulates Capval manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Capval 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 Capval manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Capval supplier is an individual or a company that provides Capval active pharmaceutical ingredient (API) or Capval finished formulations upon request. The Capval suppliers may include Capval API manufacturers, exporters, distributors and traders.
click here to find a list of Capval suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Capval DMF (Drug Master File) is a document detailing the whole manufacturing process of Capval active pharmaceutical ingredient (API) in detail. Different forms of Capval DMFs exist exist since differing nations have different regulations, such as Capval USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Capval DMF submitted to regulatory agencies in the US is known as a USDMF. Capval USDMF includes data on Capval's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Capval USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Capval 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 Capval Drug Master File in Japan (Capval JDMF) empowers Capval 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 Capval JDMF during the approval evaluation for pharmaceutical products. At the time of Capval 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 Capval 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 Capval Drug Master File in Korea (Capval KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Capval. The MFDS reviews the Capval KDMF as part of the drug registration process and uses the information provided in the Capval KDMF to evaluate the safety and efficacy of the drug.
After submitting a Capval 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 Capval API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Capval suppliers with KDMF on PharmaCompass.
A Capval CEP of the European Pharmacopoeia monograph is often referred to as a Capval Certificate of Suitability (COS). The purpose of a Capval CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Capval EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Capval to their clients by showing that a Capval CEP has been issued for it. The manufacturer submits a Capval CEP (COS) as part of the market authorization procedure, and it takes on the role of a Capval CEP holder for the record. Additionally, the data presented in the Capval CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Capval DMF.
A Capval CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Capval 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 Capval suppliers with CEP (COS) on PharmaCompass.
A Capval written confirmation (Capval WC) is an official document issued by a regulatory agency to a Capval manufacturer, verifying that the manufacturing facility of a Capval active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Capval APIs or Capval finished pharmaceutical products to another nation, regulatory agencies frequently require a Capval WC (written confirmation) as part of the regulatory process.
click here to find a list of Capval 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 Capval as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Capval 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 Capval 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 Capval and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Capval NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Capval suppliers with NDC on PharmaCompass.
Capval 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 Capval 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 Capval GMP manufacturer or Capval GMP API supplier for your needs.
A Capval CoA (Certificate of Analysis) is a formal document that attests to Capval's compliance with Capval specifications and serves as a tool for batch-level quality control.
Capval CoA mostly includes findings from lab analyses of a specific batch. For each Capval 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.
Capval may be tested according to a variety of international standards, such as European Pharmacopoeia (Capval EP), Capval JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Capval USP).
