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API SUPPLIERS
LEBSA- Your strategic API source for niche molecules.
KDMF
ASMF 
Axplora is your partner of choice for complex APIs.
BioXera Pharma: A trusted partner for high-quality human and veterinary APIs and intermediates across global regulated markets.
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Jai Radhe Sales is your partner for all your sourcing needs.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Hebei AiYoung Pharmaceutical Technology delivering high-quality APIs, intermediates, and end-to-end pharma solutions globally.
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USDMF
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LEBSA- Your strategic API source for niche molecules.
Certificate Number : CEP 2009-177 - Rev 03
Status : Valid
Issue Date : 2024-12-23
Type : Chemical
Substance Number : 1665
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : CEP 2013-240 - Rev 02
Status : Valid
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 1665
AMI Lifesciences is Driven by Chemistry. Powered by People.
Certificate Number : CEP 2011-101 - Rev 04
Status : Valid
Issue Date : 2024-07-31
Type : Chemical
Substance Number : 1665
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Betahistine Dihydrochloride EP/BP
Date of Issue : 2025-09-18
Valid Till : 2028-07-02
Written Confirmation Number : WC-0195
Address of the Firm : Plot No. 3102/B, GIDC Estate Ankleshwar, Bharuch-393002, Gujarat, India
AMI Lifesciences is Driven by Chemistry. Powered by People.
Betahistine Dihydrochloride Ph.Eur.
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post Karakhadi, Tal - Padra, Dist. Baroda, Gujara...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
LEBSA- Your strategic API source for niche molecules.
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2024-11-12
Registration Number : 20220916-211-J-1364(A)
Manufacturer Name : LABORATORIOS ESPINOS Y BOFIL...
Manufacturer Address : Ctra. De L'Hospitalet, 34 08940 Cornellà De Llobregat, Barcelona, Spain
LEBSA- Your strategic API source for niche molecules.
Registrant Name : G-Max Pharmachem Co., Ltd.
Registration Date : 2022-09-16
Registration Number : 20220916-211-J-1364
Manufacturer Name : LABORATORIOS ESPINOS Y BOFIL...
Manufacturer Address : Ctra. De L'Hospitalet, 34 08940 Cornellà De Llobregat, Barcelona, Spain
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2025-02-05
Registration Number : 20250205-211-J-1756
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2025-03-14
Registration Number : 20250205-211-J-1756(1)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
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LEBSA- Your strategic API source for niche molecules.
About the Company : Lebsa is an innovative European lab specializing in niche API synthesis, manufacture, and commercialization. With 70 years of experience, it is a reputable global player in generic...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
BioXera Pharma: A trusted partner for high-quality human and veterinary APIs and intermediates across global regulated markets.
About the Company : BioXera Pharma is a quality-focused manufacturer of APIs, veterinary APIs, and intermediates, with expertise in innovative process development for domestic and regulated internatio...
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company focused on the development, identification, production, and distribution of phytochemicals and botanical extracts. Its APIs a...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Hebei AiYoung Pharmaceutical Technology delivering high-quality APIs, intermediates, and end-to-end pharma solutions globally.
About the Company : Hebei AiYoung Pharmaceutical Group is an integrated pharmaceutical company engaged in the production, research, and sale of chemical medicines, APIs, intermediates, and finished fo...
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Betahistine Dihydrochloride 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 Betahistine Dihydrochloride manufacturer or Betahistine Dihydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betahistine Dihydrochloride manufacturer or Betahistine Dihydrochloride supplier.
A Betahistine hydrochloride (USP) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine hydrochloride (USP), including repackagers and relabelers. The FDA regulates Betahistine hydrochloride (USP) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine hydrochloride (USP) 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 Betahistine hydrochloride (USP) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Betahistine hydrochloride (USP) supplier is an individual or a company that provides Betahistine hydrochloride (USP) active pharmaceutical ingredient (API) or Betahistine hydrochloride (USP) finished formulations upon request. The Betahistine hydrochloride (USP) suppliers may include Betahistine hydrochloride (USP) API manufacturers, exporters, distributors and traders.
click here to find a list of Betahistine hydrochloride (USP) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Betahistine hydrochloride (USP) DMF (Drug Master File) is a document detailing the whole manufacturing process of Betahistine hydrochloride (USP) active pharmaceutical ingredient (API) in detail. Different forms of Betahistine hydrochloride (USP) DMFs exist exist since differing nations have different regulations, such as Betahistine hydrochloride (USP) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betahistine hydrochloride (USP) DMF submitted to regulatory agencies in the US is known as a USDMF. Betahistine hydrochloride (USP) USDMF includes data on Betahistine hydrochloride (USP)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betahistine hydrochloride (USP) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betahistine hydrochloride (USP) suppliers with USDMF 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 Betahistine hydrochloride (USP) Drug Master File in Korea (Betahistine hydrochloride (USP) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betahistine hydrochloride (USP). The MFDS reviews the Betahistine hydrochloride (USP) KDMF as part of the drug registration process and uses the information provided in the Betahistine hydrochloride (USP) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betahistine hydrochloride (USP) 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 Betahistine hydrochloride (USP) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Betahistine hydrochloride (USP) suppliers with KDMF on PharmaCompass.
A Betahistine hydrochloride (USP) CEP of the European Pharmacopoeia monograph is often referred to as a Betahistine hydrochloride (USP) Certificate of Suitability (COS). The purpose of a Betahistine hydrochloride (USP) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betahistine hydrochloride (USP) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betahistine hydrochloride (USP) to their clients by showing that a Betahistine hydrochloride (USP) CEP has been issued for it. The manufacturer submits a Betahistine hydrochloride (USP) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betahistine hydrochloride (USP) CEP holder for the record. Additionally, the data presented in the Betahistine hydrochloride (USP) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betahistine hydrochloride (USP) DMF.
A Betahistine hydrochloride (USP) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betahistine hydrochloride (USP) 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 Betahistine hydrochloride (USP) suppliers with CEP (COS) on PharmaCompass.
A Betahistine hydrochloride (USP) written confirmation (Betahistine hydrochloride (USP) WC) is an official document issued by a regulatory agency to a Betahistine hydrochloride (USP) manufacturer, verifying that the manufacturing facility of a Betahistine hydrochloride (USP) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Betahistine hydrochloride (USP) APIs or Betahistine hydrochloride (USP) finished pharmaceutical products to another nation, regulatory agencies frequently require a Betahistine hydrochloride (USP) WC (written confirmation) as part of the regulatory process.
click here to find a list of Betahistine hydrochloride (USP) 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 Betahistine hydrochloride (USP) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betahistine hydrochloride (USP) 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 Betahistine hydrochloride (USP) 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 Betahistine hydrochloride (USP) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betahistine hydrochloride (USP) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Betahistine hydrochloride (USP) suppliers with NDC on PharmaCompass.
Betahistine hydrochloride (USP) 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 Betahistine hydrochloride (USP) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Betahistine hydrochloride (USP) GMP manufacturer or Betahistine hydrochloride (USP) GMP API supplier for your needs.
A Betahistine hydrochloride (USP) CoA (Certificate of Analysis) is a formal document that attests to Betahistine hydrochloride (USP)'s compliance with Betahistine hydrochloride (USP) specifications and serves as a tool for batch-level quality control.
Betahistine hydrochloride (USP) CoA mostly includes findings from lab analyses of a specific batch. For each Betahistine hydrochloride (USP) 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.
Betahistine hydrochloride (USP) may be tested according to a variety of international standards, such as European Pharmacopoeia (Betahistine hydrochloride (USP) EP), Betahistine hydrochloride (USP) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betahistine hydrochloride (USP) USP).
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