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Aspen API. More than just an API™
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Aspen API. More than just an API™
About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...
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...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Benztropine 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 Benztropine manufacturer or Benztropine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benztropine manufacturer or Benztropine supplier.
PharmaCompass also assists you with knowing the Benztropine API Price utilized in the formulation of products. Benztropine API Price is not always fixed or binding as the Benztropine Price is obtained through a variety of data sources. The Benztropine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MK 02 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MK 02, including repackagers and relabelers. The FDA regulates MK 02 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MK 02 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 MK 02 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MK 02 supplier is an individual or a company that provides MK 02 active pharmaceutical ingredient (API) or MK 02 finished formulations upon request. The MK 02 suppliers may include MK 02 API manufacturers, exporters, distributors and traders.
click here to find a list of MK 02 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MK 02 DMF (Drug Master File) is a document detailing the whole manufacturing process of MK 02 active pharmaceutical ingredient (API) in detail. Different forms of MK 02 DMFs exist exist since differing nations have different regulations, such as MK 02 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MK 02 DMF submitted to regulatory agencies in the US is known as a USDMF. MK 02 USDMF includes data on MK 02's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MK 02 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MK 02 suppliers with USDMF 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 MK 02 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MK 02 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 MK 02 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 MK 02 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MK 02 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MK 02 suppliers with NDC on PharmaCompass.
MK 02 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 MK 02 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 MK 02 GMP manufacturer or MK 02 GMP API supplier for your needs.
A MK 02 CoA (Certificate of Analysis) is a formal document that attests to MK 02's compliance with MK 02 specifications and serves as a tool for batch-level quality control.
MK 02 CoA mostly includes findings from lab analyses of a specific batch. For each MK 02 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.
MK 02 may be tested according to a variety of international standards, such as European Pharmacopoeia (MK 02 EP), MK 02 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MK 02 USP).
