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