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API SUPPLIERS
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
KDMF
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
KDMF
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EU WC
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Registrant Name : Bansen Co., Ltd.
Registration Date : 2016-01-08
Registration Number : 20160108-171-I-474-06
Manufacturer Name : Zhejiang Hengkang Pharmaceut...
Manufacturer Address : No.1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2020-11-13
Registration Number : 20160108-171-I-474-06(1)
Manufacturer Name : Zhejiang Hengkang Pharmaceut...
Manufacturer Address : No.1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
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 Pranlukast 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 Pranlukast manufacturer or Pranlukast supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pranlukast manufacturer or Pranlukast supplier.
PharmaCompass also assists you with knowing the Pranlukast API Price utilized in the formulation of products. Pranlukast API Price is not always fixed or binding as the Pranlukast Price is obtained through a variety of data sources. The Pranlukast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pranlukast Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pranlukast Hydrate, including repackagers and relabelers. The FDA regulates Pranlukast Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pranlukast Hydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Pranlukast Hydrate supplier is an individual or a company that provides Pranlukast Hydrate active pharmaceutical ingredient (API) or Pranlukast Hydrate finished formulations upon request. The Pranlukast Hydrate suppliers may include Pranlukast Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Pranlukast Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Pranlukast Hydrate Drug Master File in Japan (Pranlukast Hydrate JDMF) empowers Pranlukast Hydrate 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 Pranlukast Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Pranlukast Hydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pranlukast Hydrate Drug Master File in Korea (Pranlukast Hydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pranlukast Hydrate. The MFDS reviews the Pranlukast Hydrate KDMF as part of the drug registration process and uses the information provided in the Pranlukast Hydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pranlukast Hydrate 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 Pranlukast Hydrate API can apply through the Korea Drug Master File (KDMF).
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A Pranlukast Hydrate written confirmation (Pranlukast Hydrate WC) is an official document issued by a regulatory agency to a Pranlukast Hydrate manufacturer, verifying that the manufacturing facility of a Pranlukast Hydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pranlukast Hydrate APIs or Pranlukast Hydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Pranlukast Hydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Pranlukast Hydrate suppliers with Written Confirmation (WC) on PharmaCompass.
Pranlukast Hydrate 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 Pranlukast Hydrate 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 Pranlukast Hydrate GMP manufacturer or Pranlukast Hydrate GMP API supplier for your needs.
A Pranlukast Hydrate CoA (Certificate of Analysis) is a formal document that attests to Pranlukast Hydrate's compliance with Pranlukast Hydrate specifications and serves as a tool for batch-level quality control.
Pranlukast Hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Pranlukast Hydrate 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.
Pranlukast Hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Pranlukast Hydrate EP), Pranlukast Hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pranlukast Hydrate USP).
