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API SUPPLIERS
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USDMF
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Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
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ABOUT THIS PAGE
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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 Bromelain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromelain, including repackagers and relabelers. The FDA regulates Bromelain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromelain 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 Bromelain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromelain supplier is an individual or a company that provides Bromelain active pharmaceutical ingredient (API) or Bromelain finished formulations upon request. The Bromelain suppliers may include Bromelain API manufacturers, exporters, distributors and traders.
click here to find a list of Bromelain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bromelain DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromelain active pharmaceutical ingredient (API) in detail. Different forms of Bromelain DMFs exist exist since differing nations have different regulations, such as Bromelain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromelain DMF submitted to regulatory agencies in the US is known as a USDMF. Bromelain USDMF includes data on Bromelain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromelain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bromelain 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 Bromelain Drug Master File in Japan (Bromelain JDMF) empowers Bromelain 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 Bromelain JDMF during the approval evaluation for pharmaceutical products. At the time of Bromelain 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 Bromelain suppliers with JDMF on PharmaCompass.
Bromelain 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 Bromelain 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 Bromelain GMP manufacturer or Bromelain GMP API supplier for your needs.
A Bromelain CoA (Certificate of Analysis) is a formal document that attests to Bromelain's compliance with Bromelain specifications and serves as a tool for batch-level quality control.
Bromelain CoA mostly includes findings from lab analyses of a specific batch. For each Bromelain 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.
Bromelain may be tested according to a variety of international standards, such as European Pharmacopoeia (Bromelain EP), Bromelain JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bromelain USP).
