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API SUPPLIERS
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Alkaloids Private Limited: WHO-GMP, USFDA, EU-GMP & ISO compliant phyto and synthetic APIs.
EU-WC
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
TW, MX 
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Aspen API. More than just an API™
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Hyoscine Butylbromide EP/BP/IP
Date of Issue : 2025-09-24
Valid Till : 2028-09-12
Written Confirmation Number : WC-0386
Address of the Firm : GTRoad, Jhattipur, Panipat-132101, Haryana, India
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Hyoscine Butyl Bromide Ph. Eur
Date of Issue : 2025-06-27
Valid Till : 2028-05-26
Written Confirmation Number : WC-0006
Address of the Firm : 25/2, Main Mathura Road, Vill- Kaili, Ballabhgarh, Faridabad, Haryana -121004, I...
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Hyoscine Butylbromide BP/IP/Ph.Eur
Date of Issue : 2024-05-29
Valid Till : 2027-05-20
Written Confirmation Number : WC-0328
Address of the Firm : SP2-5, RIICO Industrial Area, Neemrana Dist. Alwar, Rajasthan, India
Alkaloids Private Limited: WHO-GMP, USFDA, EU-GMP & ISO compliant phyto and synthetic APIs.
Date of Issue : 2022-09-30
Valid Till : 2025-02-07
Written Confirmation Number : WC-0239
Address of the Firm : 25/3, Gundlapochampally, Medchal-Malkajgiri District, Telangana - 500100, India
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
Date of Issue : 2024-05-20
Valid Till : 2027-01-08
Written Confirmation Number : WC-0300
Address of the Firm : Plot No. 1710, Phase-lll, G.I.D.C Estate, Vapi-396195, Dist.-Valsad, Gujarat, In...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-10-07
Registration Number : 20211007-210-J-649
Manufacturer Name : Alchem International P...
Manufacturer Address : SP 2-5, RIICO Industrial Area, Neemrana, Alwar-301705, Rajasthan, India
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20211130-210-J-1101
Manufacturer Name : Alchem International P...
Manufacturer Address : 25/2,Main Mathura Road,Village-Kaili,Ballabgarh,District-Faridabad-121004,Haryana
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : ETHICAL
Registration Country : Canada
Brand Name : BUSCOPAN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging : 100
Approval Date :
Application Number : 363812
Regulatory Info : ETHICAL
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : BUSCOPAN
Dosage Form : SOLUTION
Dosage Strength : 20MG/ML
Packaging : 10X1ML
Approval Date :
Application Number : 363839
Regulatory Info : PRESCRIPTION
Registration Country : Canada
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Annual Reports
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Main Therapeutic Indication : Infectious Diseases
Currency : USD
2019 Revenue in Millions : 206
2018 Revenue in Millions : 211
Growth (%) : -3
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Main Therapeutic Indication : Infectious Diseases
Currency : USD
2020 Revenue in Millions : 214
2019 Revenue in Millions : 229
Growth (%) : -6
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Main Therapeutic Indication : Anti-Inflammatory
Currency : USD
2018 Revenue in Millions : 219
2017 Revenue in Millions : 216
Growth (%) : 2%
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Hyoscine Butyl 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 Hyoscine Butyl Bromide manufacturer or Hyoscine Butyl Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hyoscine Butyl Bromide manufacturer or Hyoscine Butyl Bromide supplier.
A Hyoscine butobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyoscine butobromide, including repackagers and relabelers. The FDA regulates Hyoscine butobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyoscine butobromide 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 Hyoscine butobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hyoscine butobromide supplier is an individual or a company that provides Hyoscine butobromide active pharmaceutical ingredient (API) or Hyoscine butobromide finished formulations upon request. The Hyoscine butobromide suppliers may include Hyoscine butobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Hyoscine butobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information 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 Hyoscine butobromide Drug Master File in Japan (Hyoscine butobromide JDMF) empowers Hyoscine butobromide 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 Hyoscine butobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Hyoscine butobromide 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 Hyoscine butobromide 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 Hyoscine butobromide Drug Master File in Korea (Hyoscine butobromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hyoscine butobromide. The MFDS reviews the Hyoscine butobromide KDMF as part of the drug registration process and uses the information provided in the Hyoscine butobromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hyoscine butobromide 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 Hyoscine butobromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hyoscine butobromide suppliers with KDMF on PharmaCompass.
A Hyoscine butobromide CEP of the European Pharmacopoeia monograph is often referred to as a Hyoscine butobromide Certificate of Suitability (COS). The purpose of a Hyoscine butobromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hyoscine butobromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hyoscine butobromide to their clients by showing that a Hyoscine butobromide CEP has been issued for it. The manufacturer submits a Hyoscine butobromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hyoscine butobromide CEP holder for the record. Additionally, the data presented in the Hyoscine butobromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hyoscine butobromide DMF.
A Hyoscine butobromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyoscine butobromide 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 Hyoscine butobromide suppliers with CEP (COS) on PharmaCompass.
A Hyoscine butobromide written confirmation (Hyoscine butobromide WC) is an official document issued by a regulatory agency to a Hyoscine butobromide manufacturer, verifying that the manufacturing facility of a Hyoscine butobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hyoscine butobromide APIs or Hyoscine butobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Hyoscine butobromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Hyoscine butobromide 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 Hyoscine butobromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hyoscine butobromide 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 Hyoscine butobromide 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 Hyoscine butobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hyoscine butobromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hyoscine butobromide suppliers with NDC on PharmaCompass.
Hyoscine butobromide 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 Hyoscine butobromide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Hyoscine butobromide GMP manufacturer or Hyoscine butobromide GMP API supplier for your needs.
A Hyoscine butobromide CoA (Certificate of Analysis) is a formal document that attests to Hyoscine butobromide's compliance with Hyoscine butobromide specifications and serves as a tool for batch-level quality control.
Hyoscine butobromide CoA mostly includes findings from lab analyses of a specific batch. For each Hyoscine butobromide 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.
Hyoscine butobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Hyoscine butobromide EP), Hyoscine butobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hyoscine butobromide USP).
