Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
FDF
0
Weekly News Recap #Phispers
1. Mls001401438
2. Chembl1895091
3. Hms2051p14
4. Hms2233m10
5. Ccg-101038
6. Nc00288
7. Smr000471620
| Molecular Weight | 478.5 g/mol |
|---|---|
| Molecular Formula | C23H30N2O9 |
| Hydrogen Bond Donor Count | 7 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 10 |
| Exact Mass | 478.19513054 g/mol |
| Monoisotopic Mass | 478.19513054 g/mol |
| Topological Polar Surface Area | 166 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 507 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
API SUPPLIERS
Inke S.A: APIs manufacturing plant.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-16
Pay. Date : 2017-05-10
DMF Number : 16628
Submission : 2003-06-03
Status : Active
Type : II
Certificate Number : CEP 2006-024 - Rev 03
Issue Date : 2025-03-27
Type : Chemical
Substance Number : 1724
Status : Valid
Registration Number : 224MF10042
Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN
Initial Date of Registration : 2012-02-28
Latest Date of Registration :
NDC Package Code : 64567-0006
Start Marketing Date : 2008-06-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-08-19
Registration Number : 20130819-187-I-288-06
Manufacturer Name : INKE SA
Manufacturer Address : Argent,1, Area Industrial del Llobregat, Castellbisbal 08755 (Barcelona), Spain.
| Available Reg Filing : CN |
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30324
Submission : 2016-06-04
Status : Active
Type : II
Certificate Number : R1-CEP 2016-105 - Rev 00
Issue Date : 2022-09-28
Type : Chemical
Substance Number : 1724
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009n
Address of the Firm :
NDC Package Code : 49076-7001
Start Marketing Date : 2016-02-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Certificate Number : R1-CEP 2006-227 - Rev 02
Issue Date : 2022-07-28
Type : Chemical
Substance Number : 1724
Status : Valid
Date of Issue : 2022-06-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0155
Address of the Firm :
NDC Package Code : 66412-0204
Start Marketing Date : 2023-09-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32936
Submission : 2018-07-27
Status : Active
Type : II
Certificate Number : R1-CEP 2010-132 - Rev 01
Issue Date : 2017-08-11
Type : Chemical
Substance Number : 1724
Status : Valid
NDC Package Code : 46439-8763
Start Marketing Date : 2018-06-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-19
Pay. Date : 2019-06-25
DMF Number : 33894
Submission : 2019-07-12
Status : Active
Type : II
Certificate Number : CEP 2015-215 - Rev 02
Issue Date : 2023-09-04
Type : Chemical
Substance Number : 1724
Status : Valid
Registration Number : 229MF10159
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2017-08-17
Latest Date of Registration :
NDC Package Code : 12780-4880
Start Marketing Date : 2016-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : CN |
Jai Radhe Sales is your partner for all your sourcing needs.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2017-09-01
Registration Number : 20160310-187-I-468-08(1)
Manufacturer Name : Aarti Industries Limited.
Manufacturer Address : Unit-IV, Plot No. E-50, MIDC, Tarapur, TAL, Palghar, Dist Thane 401506, Maharashtra State, India
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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Regulatory Info :
Registration Country : Italy
Brand Name : Fobuler
Dosage Form : Budesonide+Formoterol 320+9Mcg 60 Doses Respiratory Use + Easyhaler
Dosage Strength : easyhaler groun inhal 60 doses 320 mcg + 9 mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Bufomix Easy Tails
Dosage Form : Inhalasjonspulver
Dosage Strength : 160MCG/Dose; 4.5MCG/Dose
Packaging : Inhalator with protection holster
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Bufomix Easy Tails
Dosage Form : Inhalasjonspulver
Dosage Strength : 160MCG/Dose; 4.5MCG/Dose
Packaging : Inhalator
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Bufomix Easy Tails
Dosage Form : Inhalasjonspulver
Dosage Strength : 320MCG/Dose; 9MCG/Dose
Packaging : Inhalator with protection holster
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Bufomix Easy Tails
Dosage Form : Inhalasjonspulver
Dosage Strength : 320MCG/Dose; 9MCG/Dose
Packaging : Inhalator
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : FOBULER
Dosage Form : Inhalation Powder For Pre-Dosed Inhalation
Dosage Strength : 160 micrograms/4.5 micrograms
Packaging : 120 DOSES (160+4.5) MCG - RESPIRATORY USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : FOBULER
Dosage Form : Inhalation Powder For Pre-Dosed Inhalation
Dosage Strength : 320 micrograms/9 micrograms
Packaging : 60 DOSES (320+9) MCG - RESPIRATORY USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Budesonide, Formoterol Fumarate Dihydrate
Brand Name : Bufomix Easyhaler
Dosage Form : Inhalation powder
Dosage Strength : 160 microg/4.5 microg
Packaging : Inhaler with protective sleeve 120doses
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Budesonide, Formoterol Fumarate Dihydrate
Brand Name : Bufomix Easyhaler
Dosage Form : Inhalation powder
Dosage Strength : 320 microg/9 microg
Packaging : Inhaler with protective sleeve 60doses
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Budesonide, Formoterol Fumarate Dihydrate
Brand Name : Bufomix Easyhaler
Dosage Form : Inhalation powder
Dosage Strength : 320 microg/9 microg
Packaging : Inhaler 3 60doses
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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DOSAGE - POWDER;INHALATION - 0.012MG/INH **Fe...DOSAGE - POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20831
DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH
USFDA APPLICATION NUMBER - 210595
DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH
USFDA APPLICATION NUMBER - 21929
DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH
USFDA APPLICATION NUMBER - 21929
DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH
USFDA APPLICATION NUMBER - 22518
DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH
USFDA APPLICATION NUMBER - 22518
DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH
USFDA APPLICATION NUMBER - 22518
Related Excipient Companies
Nanjing Well Pharmaceutical
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Dosage Form : Granule / Pellet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for tablets.
Dosage Form : Granule / Pellet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for lozenges, chewables and effervescent tablets.
Pharmacopoeia Ref : Ph. Eur., USP/NF and J.P
Technical Specs : Not Available
Ingredient(s) : Lactose
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PharmaCompass offers a list of Formoterol Fumarate 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 Formoterol Fumarate manufacturer or Formoterol Fumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Formoterol Fumarate manufacturer or Formoterol Fumarate supplier.
PharmaCompass also assists you with knowing the Formoterol Fumarate API Price utilized in the formulation of products. Formoterol Fumarate API Price is not always fixed or binding as the Formoterol Fumarate Price is obtained through a variety of data sources. The Formoterol Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A SYMBICORT-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SYMBICORT-1, including repackagers and relabelers. The FDA regulates SYMBICORT-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SYMBICORT-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 SYMBICORT-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SYMBICORT-1 supplier is an individual or a company that provides SYMBICORT-1 active pharmaceutical ingredient (API) or SYMBICORT-1 finished formulations upon request. The SYMBICORT-1 suppliers may include SYMBICORT-1 API manufacturers, exporters, distributors and traders.
click here to find a list of SYMBICORT-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SYMBICORT-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of SYMBICORT-1 active pharmaceutical ingredient (API) in detail. Different forms of SYMBICORT-1 DMFs exist exist since differing nations have different regulations, such as SYMBICORT-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SYMBICORT-1 DMF submitted to regulatory agencies in the US is known as a USDMF. SYMBICORT-1 USDMF includes data on SYMBICORT-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SYMBICORT-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SYMBICORT-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 SYMBICORT-1 Drug Master File in Japan (SYMBICORT-1 JDMF) empowers SYMBICORT-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 SYMBICORT-1 JDMF during the approval evaluation for pharmaceutical products. At the time of SYMBICORT-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 SYMBICORT-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 SYMBICORT-1 Drug Master File in Korea (SYMBICORT-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SYMBICORT-1. The MFDS reviews the SYMBICORT-1 KDMF as part of the drug registration process and uses the information provided in the SYMBICORT-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a SYMBICORT-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 SYMBICORT-1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SYMBICORT-1 suppliers with KDMF on PharmaCompass.
A SYMBICORT-1 CEP of the European Pharmacopoeia monograph is often referred to as a SYMBICORT-1 Certificate of Suitability (COS). The purpose of a SYMBICORT-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SYMBICORT-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SYMBICORT-1 to their clients by showing that a SYMBICORT-1 CEP has been issued for it. The manufacturer submits a SYMBICORT-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a SYMBICORT-1 CEP holder for the record. Additionally, the data presented in the SYMBICORT-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SYMBICORT-1 DMF.
A SYMBICORT-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SYMBICORT-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 SYMBICORT-1 suppliers with CEP (COS) on PharmaCompass.
A SYMBICORT-1 written confirmation (SYMBICORT-1 WC) is an official document issued by a regulatory agency to a SYMBICORT-1 manufacturer, verifying that the manufacturing facility of a SYMBICORT-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SYMBICORT-1 APIs or SYMBICORT-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a SYMBICORT-1 WC (written confirmation) as part of the regulatory process.
click here to find a list of SYMBICORT-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 SYMBICORT-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SYMBICORT-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 SYMBICORT-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 SYMBICORT-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SYMBICORT-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SYMBICORT-1 suppliers with NDC on PharmaCompass.
SYMBICORT-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 SYMBICORT-1 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 SYMBICORT-1 GMP manufacturer or SYMBICORT-1 GMP API supplier for your needs.
A SYMBICORT-1 CoA (Certificate of Analysis) is a formal document that attests to SYMBICORT-1's compliance with SYMBICORT-1 specifications and serves as a tool for batch-level quality control.
SYMBICORT-1 CoA mostly includes findings from lab analyses of a specific batch. For each SYMBICORT-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.
SYMBICORT-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (SYMBICORT-1 EP), SYMBICORT-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SYMBICORT-1 USP).
