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EU WC
AMI Lifesciences is Driven by Chemistry. Powered by People.
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City Karakhadi -39145...
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Pampia Co., Ltd.
Registration Date : 2021-06-26
Registration Number : 20140313-152-I-341-08(1)
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road., At & Post. Karakhadi, Tal-Padra, City: Karakhadi - 390 450...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2014-03-13
Registration Number : 20140313-152-I-341-08
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road., At & Post. Karakhadi, Tal-Padra, City: Karakhadi - 390 450...
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AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Acebrophylline 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 Acebrophylline manufacturer or Acebrophylline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acebrophylline manufacturer or Acebrophylline supplier.
PharmaCompass also assists you with knowing the Acebrophylline API Price utilized in the formulation of products. Acebrophylline API Price is not always fixed or binding as the Acebrophylline Price is obtained through a variety of data sources. The Acebrophylline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Acebrophylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acebrophylline, including repackagers and relabelers. The FDA regulates Acebrophylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acebrophylline 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 Acebrophylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acebrophylline supplier is an individual or a company that provides Acebrophylline active pharmaceutical ingredient (API) or Acebrophylline finished formulations upon request. The Acebrophylline suppliers may include Acebrophylline API manufacturers, exporters, distributors and traders.
click here to find a list of Acebrophylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Acebrophylline Drug Master File in Korea (Acebrophylline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acebrophylline. The MFDS reviews the Acebrophylline KDMF as part of the drug registration process and uses the information provided in the Acebrophylline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acebrophylline 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 Acebrophylline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acebrophylline suppliers with KDMF on PharmaCompass.
A Acebrophylline written confirmation (Acebrophylline WC) is an official document issued by a regulatory agency to a Acebrophylline manufacturer, verifying that the manufacturing facility of a Acebrophylline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acebrophylline APIs or Acebrophylline finished pharmaceutical products to another nation, regulatory agencies frequently require a Acebrophylline WC (written confirmation) as part of the regulatory process.
click here to find a list of Acebrophylline suppliers with Written Confirmation (WC) on PharmaCompass.
Acebrophylline 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 Acebrophylline 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 Acebrophylline GMP manufacturer or Acebrophylline GMP API supplier for your needs.
A Acebrophylline CoA (Certificate of Analysis) is a formal document that attests to Acebrophylline's compliance with Acebrophylline specifications and serves as a tool for batch-level quality control.
Acebrophylline CoA mostly includes findings from lab analyses of a specific batch. For each Acebrophylline 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.
Acebrophylline may be tested according to a variety of international standards, such as European Pharmacopoeia (Acebrophylline EP), Acebrophylline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acebrophylline USP).
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