Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Certificate Number : CEP 2011-005 - Rev 02
Status : Valid
Issue Date : 2024-12-23
Type : Chemical
Substance Number : 809
Axplora is your partner of choice for complex APIs.
Betamethasone Dipropionate, Micronised
Certificate Number : R1-CEP 2003-232 - Rev 03
Status : Valid
Issue Date : 2023-02-08
Type : Chemical
Substance Number : 809
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2000-223 - Rev 09
Status : Valid
Issue Date : 2025-08-08
Type : Chemical
Substance Number : 809
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Certificate Number : R1-CEP 2002-031 - Rev 03
Status : Valid
Issue Date : 2021-08-24
Type : Chemical
Substance Number : 809
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovatio...
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
About the Company : Symbiotica is a Malaysia-based manufacturer of high-quality Active Pharmaceutical Ingredients (APIs), specialising in steroidal, hormonal, and niche non-steroidal compounds for glo...
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...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
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 based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
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...
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...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
About the Company : Swati Spentose Pvt. Ltd. (SSPL), part of the 60-year-old V Group, is a globally trusted pharmaceutical manufacturer supplying to 70+ countries. We specialize in high-quality APIs a...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
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DOSAGE - OINTMENT, AUGMENTED;TOPICAL - EQ 0.0...DOSAGE - OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE
USFDA APPLICATION NUMBER - 18741
DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE;1% **F...DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18827
DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE
USFDA APPLICATION NUMBER - 19137
DOSAGE - OINTMENT;TOPICAL - EQ 0.05% BASE
USFDA APPLICATION NUMBER - 19141
DOSAGE - CREAM, AUGMENTED;TOPICAL - EQ 0.05% ...DOSAGE - CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19555
DOSAGE - LOTION, AUGMENTED;TOPICAL - EQ 0.05%...DOSAGE - LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19716
DOSAGE - OINTMENT;TOPICAL - 0.064%;0.005%
USFDA APPLICATION NUMBER - 21852
DOSAGE - SUSPENSION;TOPICAL - 0.064%;0.005%
USFDA APPLICATION NUMBER - 22185
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Film Formers & Plasticizers
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Solubilizers
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Taste Masking
Lubricants & Glidants
Direct Compression
Surfactant & Foaming Agents
Controlled & Modified Release
Granulation
Chewable & Orodispersible Aids
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API Stability Enhancers
Soft Gelatin
Rheology Modifiers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Betamethasone Dipropionate 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 Betamethasone Dipropionate manufacturer or Betamethasone Dipropionate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betamethasone Dipropionate manufacturer or Betamethasone Dipropionate supplier.
A Maxivate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maxivate, including repackagers and relabelers. The FDA regulates Maxivate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maxivate 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 Maxivate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Maxivate supplier is an individual or a company that provides Maxivate active pharmaceutical ingredient (API) or Maxivate finished formulations upon request. The Maxivate suppliers may include Maxivate API manufacturers, exporters, distributors and traders.
click here to find a list of Maxivate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Maxivate DMF (Drug Master File) is a document detailing the whole manufacturing process of Maxivate active pharmaceutical ingredient (API) in detail. Different forms of Maxivate DMFs exist exist since differing nations have different regulations, such as Maxivate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maxivate DMF submitted to regulatory agencies in the US is known as a USDMF. Maxivate USDMF includes data on Maxivate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maxivate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maxivate 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 Maxivate Drug Master File in Japan (Maxivate JDMF) empowers Maxivate 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 Maxivate JDMF during the approval evaluation for pharmaceutical products. At the time of Maxivate 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 Maxivate 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 Maxivate Drug Master File in Korea (Maxivate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Maxivate. The MFDS reviews the Maxivate KDMF as part of the drug registration process and uses the information provided in the Maxivate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Maxivate 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 Maxivate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Maxivate suppliers with KDMF on PharmaCompass.
A Maxivate CEP of the European Pharmacopoeia monograph is often referred to as a Maxivate Certificate of Suitability (COS). The purpose of a Maxivate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Maxivate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Maxivate to their clients by showing that a Maxivate CEP has been issued for it. The manufacturer submits a Maxivate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Maxivate CEP holder for the record. Additionally, the data presented in the Maxivate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Maxivate DMF.
A Maxivate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Maxivate 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 Maxivate suppliers with CEP (COS) on PharmaCompass.
A Maxivate written confirmation (Maxivate WC) is an official document issued by a regulatory agency to a Maxivate manufacturer, verifying that the manufacturing facility of a Maxivate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Maxivate APIs or Maxivate finished pharmaceutical products to another nation, regulatory agencies frequently require a Maxivate WC (written confirmation) as part of the regulatory process.
click here to find a list of Maxivate 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 Maxivate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Maxivate 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 Maxivate 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 Maxivate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Maxivate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Maxivate suppliers with NDC on PharmaCompass.
Maxivate 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 Maxivate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Maxivate GMP manufacturer or Maxivate GMP API supplier for your needs.
A Maxivate CoA (Certificate of Analysis) is a formal document that attests to Maxivate's compliance with Maxivate specifications and serves as a tool for batch-level quality control.
Maxivate CoA mostly includes findings from lab analyses of a specific batch. For each Maxivate 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.
Maxivate may be tested according to a variety of international standards, such as European Pharmacopoeia (Maxivate EP), Maxivate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Maxivate USP).
