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API SUPPLIERS
Basic Nutrition, your expert for sourcing from China, India and Europe.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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USDMF
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Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
USFDA APPLICATION NUMBER - 18920
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
USFDA APPLICATION NUMBER - 21625
DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
USFDA APPLICATION NUMBER - 8809
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Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : ACTILLETS™ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.
Pharmacopoeia Ref : NA
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Dosage Form : Tablet
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Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 490- 500, Tapped Density: 1.50
Ingredient(s) : Calcium Carbonate Excipient
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Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175, Tapped Density: 0.85
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SPI Pharma has been solving formulation challenges using superior functional materials.
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Excipient Details : DC SIM 100 is a directly compressible simethicone powder used for antacid and anti-gas tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
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SPI Pharma has been solving formulation challenges using superior functional materials.
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Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170, Taped Density: 0.80
Ingredient(s) : Starch
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Dosage Form : Cream / Lotion / Ointment
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical
Application : Topical
Excipient Details : Inositol is used in topical dosage forms such as creams, lotions and ointments.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Excipient Details : L-arginine is used as a cryoprotective agent and solution additive to help stabilize proteins against aggregation.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Biotin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biotin, including repackagers and relabelers. The FDA regulates Biotin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biotin 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 Biotin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biotin supplier is an individual or a company that provides Biotin active pharmaceutical ingredient (API) or Biotin finished formulations upon request. The Biotin suppliers may include Biotin API manufacturers, exporters, distributors and traders.
click here to find a list of Biotin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Biotin DMF (Drug Master File) is a document detailing the whole manufacturing process of Biotin active pharmaceutical ingredient (API) in detail. Different forms of Biotin DMFs exist exist since differing nations have different regulations, such as Biotin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Biotin DMF submitted to regulatory agencies in the US is known as a USDMF. Biotin USDMF includes data on Biotin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biotin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Biotin 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 Biotin Drug Master File in Japan (Biotin JDMF) empowers Biotin 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 Biotin JDMF during the approval evaluation for pharmaceutical products. At the time of Biotin 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 Biotin 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 Biotin Drug Master File in Korea (Biotin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Biotin. The MFDS reviews the Biotin KDMF as part of the drug registration process and uses the information provided in the Biotin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Biotin 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 Biotin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Biotin suppliers with KDMF on PharmaCompass.
A Biotin CEP of the European Pharmacopoeia monograph is often referred to as a Biotin Certificate of Suitability (COS). The purpose of a Biotin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Biotin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Biotin to their clients by showing that a Biotin CEP has been issued for it. The manufacturer submits a Biotin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Biotin CEP holder for the record. Additionally, the data presented in the Biotin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Biotin DMF.
A Biotin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Biotin 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 Biotin suppliers with CEP (COS) 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 Biotin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Biotin 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 Biotin 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 Biotin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Biotin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Biotin suppliers with NDC on PharmaCompass.
Biotin 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 Biotin 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 Biotin GMP manufacturer or Biotin GMP API supplier for your needs.
A Biotin CoA (Certificate of Analysis) is a formal document that attests to Biotin's compliance with Biotin specifications and serves as a tool for batch-level quality control.
Biotin CoA mostly includes findings from lab analyses of a specific batch. For each Biotin 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.
Biotin may be tested according to a variety of international standards, such as European Pharmacopoeia (Biotin EP), Biotin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Biotin USP).
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