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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
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USDMF
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Date of Issue : 2024-01-16
Valid Till : 2027-01-27
Written Confirmation Number : SD240011
Address of the Firm : Ringroad No. 8, High-Tech Development Zone, Jining, Shandong, China 272100
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
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Drugs in Development
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DOSAGE - POWDER;INTRAVENOUS - EQ 1.25GM BASE/...DOSAGE - POWDER;INTRAVENOUS - EQ 1.25GM BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 1.5GM BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 1.5GM BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 1.75GM BASE/...DOSAGE - POWDER;INTRAVENOUS - EQ 1.75GM BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 250MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 2GM BASE/VIA...DOSAGE - POWDER;INTRAVENOUS - EQ 2GM BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 750MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 750MG BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 1.25GM...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 1.25GM BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 1.5MG ...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 1.5MG BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 10GM B...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 10GM BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 1GM BA...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 1GM BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 500MG ...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 500MG BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 5GM BA...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 5GM BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 750MG ...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 750MG BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - CAPSULE;ORAL - EQ 125MG BASE
USFDA APPLICATION NUMBER - 50606
DOSAGE - CAPSULE;ORAL - EQ 250MG BASE
USFDA APPLICATION NUMBER - 50606
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Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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PharmaCompass offers a list of Vancomycin Hydrochloride 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 Vancomycin Hydrochloride manufacturer or Vancomycin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vancomycin Hydrochloride manufacturer or Vancomycin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Vancomycin Hydrochloride API Price utilized in the formulation of products. Vancomycin Hydrochloride API Price is not always fixed or binding as the Vancomycin Hydrochloride Price is obtained through a variety of data sources. The Vancomycin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vancomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vancomycin, including repackagers and relabelers. The FDA regulates Vancomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vancomycin 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 Vancomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vancomycin supplier is an individual or a company that provides Vancomycin active pharmaceutical ingredient (API) or Vancomycin finished formulations upon request. The Vancomycin suppliers may include Vancomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Vancomycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vancomycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Vancomycin active pharmaceutical ingredient (API) in detail. Different forms of Vancomycin DMFs exist exist since differing nations have different regulations, such as Vancomycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vancomycin DMF submitted to regulatory agencies in the US is known as a USDMF. Vancomycin USDMF includes data on Vancomycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vancomycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vancomycin 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 Vancomycin Drug Master File in Japan (Vancomycin JDMF) empowers Vancomycin 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 Vancomycin JDMF during the approval evaluation for pharmaceutical products. At the time of Vancomycin 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 Vancomycin 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 Vancomycin Drug Master File in Korea (Vancomycin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vancomycin. The MFDS reviews the Vancomycin KDMF as part of the drug registration process and uses the information provided in the Vancomycin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vancomycin 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 Vancomycin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vancomycin suppliers with KDMF on PharmaCompass.
A Vancomycin CEP of the European Pharmacopoeia monograph is often referred to as a Vancomycin Certificate of Suitability (COS). The purpose of a Vancomycin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vancomycin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vancomycin to their clients by showing that a Vancomycin CEP has been issued for it. The manufacturer submits a Vancomycin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vancomycin CEP holder for the record. Additionally, the data presented in the Vancomycin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vancomycin DMF.
A Vancomycin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vancomycin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Vancomycin suppliers with CEP (COS) on PharmaCompass.
A Vancomycin written confirmation (Vancomycin WC) is an official document issued by a regulatory agency to a Vancomycin manufacturer, verifying that the manufacturing facility of a Vancomycin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vancomycin APIs or Vancomycin finished pharmaceutical products to another nation, regulatory agencies frequently require a Vancomycin WC (written confirmation) as part of the regulatory process.
click here to find a list of Vancomycin 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 Vancomycin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vancomycin 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 Vancomycin 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 Vancomycin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vancomycin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vancomycin suppliers with NDC on PharmaCompass.
Vancomycin 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 Vancomycin 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 Vancomycin GMP manufacturer or Vancomycin GMP API supplier for your needs.
A Vancomycin CoA (Certificate of Analysis) is a formal document that attests to Vancomycin's compliance with Vancomycin specifications and serves as a tool for batch-level quality control.
Vancomycin CoA mostly includes findings from lab analyses of a specific batch. For each Vancomycin 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.
Vancomycin may be tested according to a variety of international standards, such as European Pharmacopoeia (Vancomycin EP), Vancomycin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vancomycin USP).
