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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-24
Pay. Date : 2013-09-25
DMF Number : 27483
Submission : 2013-09-20
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-03
Pay. Date : 2012-11-29
DMF Number : 24823
Submission : 2011-03-30
Status :
Type : II
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Drugs in Development
Lead Product(s) : Ibrutinib,Bendamustine Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Johnson & Johnson Innovative Medicine
Deal Size : Not Applicable
Deal Type : Not Applicable
Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal...
Details : The disappointed outcome of the confirmatory trials leads to voluntarily withdraw, in the U.S., accelerated IMBRUVICA® (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma who have received at least one prior therapy and with m...
Brand Name : Imbruvica
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 06, 2023
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DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)
USFDA APPLICATION NUMBER - 205580
DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)
USFDA APPLICATION NUMBER - 208194
DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)
USFDA APPLICATION NUMBER - 215033
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Bendamustine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bendamustine Hydrochloride, including repackagers and relabelers. The FDA regulates Bendamustine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bendamustine Hydrochloride 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 Bendamustine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bendamustine Hydrochloride supplier is an individual or a company that provides Bendamustine Hydrochloride active pharmaceutical ingredient (API) or Bendamustine Hydrochloride finished formulations upon request. The Bendamustine Hydrochloride suppliers may include Bendamustine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Bendamustine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bendamustine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Bendamustine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Bendamustine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Bendamustine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bendamustine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Bendamustine Hydrochloride USDMF includes data on Bendamustine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bendamustine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bendamustine Hydrochloride 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 Bendamustine Hydrochloride Drug Master File in Japan (Bendamustine Hydrochloride JDMF) empowers Bendamustine Hydrochloride 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 Bendamustine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Bendamustine Hydrochloride 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 Bendamustine Hydrochloride suppliers with JDMF 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 Bendamustine Hydrochloride Drug Master File in Korea (Bendamustine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bendamustine Hydrochloride. The MFDS reviews the Bendamustine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Bendamustine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bendamustine Hydrochloride 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 Bendamustine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bendamustine Hydrochloride suppliers with KDMF on PharmaCompass.
A Bendamustine Hydrochloride written confirmation (Bendamustine Hydrochloride WC) is an official document issued by a regulatory agency to a Bendamustine Hydrochloride manufacturer, verifying that the manufacturing facility of a Bendamustine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bendamustine Hydrochloride APIs or Bendamustine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Bendamustine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Bendamustine Hydrochloride suppliers with Written Confirmation (WC) 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 Bendamustine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bendamustine Hydrochloride 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 Bendamustine Hydrochloride 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 Bendamustine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bendamustine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bendamustine Hydrochloride suppliers with NDC on PharmaCompass.
Bendamustine Hydrochloride 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 Bendamustine Hydrochloride 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 Bendamustine Hydrochloride GMP manufacturer or Bendamustine Hydrochloride GMP API supplier for your needs.
A Bendamustine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Bendamustine Hydrochloride's compliance with Bendamustine Hydrochloride specifications and serves as a tool for batch-level quality control.
Bendamustine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Bendamustine Hydrochloride 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.
Bendamustine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Bendamustine Hydrochloride EP), Bendamustine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bendamustine Hydrochloride USP).
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