Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Neuland Laboratories- A dedicated 100% API provider.
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
Neuland Laboratories- A dedicated 100% API provider.
Neuland Laboratories- A dedicated 100% API provider.
Neuland Laboratories- A dedicated 100% API provider.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Regulatory Info : Prescription
Registration Country : Denmark
Phenoterol Hydrobromide; Ipratropium Bromide
Brand Name : Ipratropiumbromid+Fenoterolhydrobromid \"Farmak\"
Dosage Form : Solution For Inhalation
Dosage Strength : 0.5mg/4ml; 1.25mg/4ml
Packaging :
Approval Date : 14-03-2025
Application Number : 28107059023
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Ipratropium Bromide; Salbutamol Sulfate
Brand Name : Ipratropium/Salbutamol \"Orion\"
Dosage Form : Nebulizer Inhalation Solution
Dosage Strength : 0.5mg/inh; 2.5mg/inh
Packaging :
Approval Date : 13-11-2014
Application Number : 28105297713
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Approved
Registration Country : Sweden
Ipratropium Bromide (Monohydrate); Salbutamol Sulfate
Brand Name : Ipratropium/Salbutamol Orion
Dosage Form : Inhalation Solution
Dosage Strength : 0.5mg/2.5ml;2.5mg/2.5ml
Packaging :
Approval Date : 06-11-2014
Application Number : 2.01E+13
Regulatory Info : Approved
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SPRAY, METERED;NASAL - 0.021MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20393
DOSAGE - SPRAY, METERED;NASAL - 0.042MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20394
DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20950
Related Excipient Companies
Kirsch Pharma
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Thickeners and Stabilizers
Excipient Details : Used as a chelating agent in cell culture media, downstream and as a chelator stabilizer in Biopharmaceutical formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Disodium Edetate Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Sodium Chloride Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Solubilizers
Thickeners and Stabilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
10 Sep 2022
Reply
20 Nov 2020
Reply
23 Oct 2019
Reply
07 Sep 2019
Reply
22 Apr 2019
Reply
10 Apr 2019
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
95
PharmaCompass offers a list of Ipratropium Bromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ipratropium Bromide manufacturer or Ipratropium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ipratropium Bromide manufacturer or Ipratropium Bromide supplier.
A COMBIVENT-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of COMBIVENT-1, including repackagers and relabelers. The FDA regulates COMBIVENT-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. COMBIVENT-1 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 COMBIVENT-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A COMBIVENT-1 supplier is an individual or a company that provides COMBIVENT-1 active pharmaceutical ingredient (API) or COMBIVENT-1 finished formulations upon request. The COMBIVENT-1 suppliers may include COMBIVENT-1 API manufacturers, exporters, distributors and traders.
click here to find a list of COMBIVENT-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A COMBIVENT-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of COMBIVENT-1 active pharmaceutical ingredient (API) in detail. Different forms of COMBIVENT-1 DMFs exist exist since differing nations have different regulations, such as COMBIVENT-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A COMBIVENT-1 DMF submitted to regulatory agencies in the US is known as a USDMF. COMBIVENT-1 USDMF includes data on COMBIVENT-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The COMBIVENT-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of COMBIVENT-1 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 COMBIVENT-1 Drug Master File in Japan (COMBIVENT-1 JDMF) empowers COMBIVENT-1 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 COMBIVENT-1 JDMF during the approval evaluation for pharmaceutical products. At the time of COMBIVENT-1 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 COMBIVENT-1 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 COMBIVENT-1 Drug Master File in Korea (COMBIVENT-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of COMBIVENT-1. The MFDS reviews the COMBIVENT-1 KDMF as part of the drug registration process and uses the information provided in the COMBIVENT-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a COMBIVENT-1 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 COMBIVENT-1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of COMBIVENT-1 suppliers with KDMF on PharmaCompass.
A COMBIVENT-1 CEP of the European Pharmacopoeia monograph is often referred to as a COMBIVENT-1 Certificate of Suitability (COS). The purpose of a COMBIVENT-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of COMBIVENT-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of COMBIVENT-1 to their clients by showing that a COMBIVENT-1 CEP has been issued for it. The manufacturer submits a COMBIVENT-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a COMBIVENT-1 CEP holder for the record. Additionally, the data presented in the COMBIVENT-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the COMBIVENT-1 DMF.
A COMBIVENT-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. COMBIVENT-1 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 COMBIVENT-1 suppliers with CEP (COS) on PharmaCompass.
A COMBIVENT-1 written confirmation (COMBIVENT-1 WC) is an official document issued by a regulatory agency to a COMBIVENT-1 manufacturer, verifying that the manufacturing facility of a COMBIVENT-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting COMBIVENT-1 APIs or COMBIVENT-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a COMBIVENT-1 WC (written confirmation) as part of the regulatory process.
click here to find a list of COMBIVENT-1 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 COMBIVENT-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for COMBIVENT-1 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 COMBIVENT-1 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 COMBIVENT-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a COMBIVENT-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of COMBIVENT-1 suppliers with NDC on PharmaCompass.
COMBIVENT-1 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 COMBIVENT-1 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right COMBIVENT-1 GMP manufacturer or COMBIVENT-1 GMP API supplier for your needs.
A COMBIVENT-1 CoA (Certificate of Analysis) is a formal document that attests to COMBIVENT-1's compliance with COMBIVENT-1 specifications and serves as a tool for batch-level quality control.
COMBIVENT-1 CoA mostly includes findings from lab analyses of a specific batch. For each COMBIVENT-1 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.
COMBIVENT-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (COMBIVENT-1 EP), COMBIVENT-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (COMBIVENT-1 USP).
Comment (2)
