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API SUPPLIERS
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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...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium manufacturer or Pentosan Polysulfate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pentosan Polysulfate Sodium manufacturer or Pentosan Polysulfate Sodium supplier.
A Hemoclar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hemoclar, including repackagers and relabelers. The FDA regulates Hemoclar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hemoclar 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 Hemoclar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hemoclar supplier is an individual or a company that provides Hemoclar active pharmaceutical ingredient (API) or Hemoclar finished formulations upon request. The Hemoclar suppliers may include Hemoclar API manufacturers, exporters, distributors and traders.
click here to find a list of Hemoclar suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hemoclar DMF (Drug Master File) is a document detailing the whole manufacturing process of Hemoclar active pharmaceutical ingredient (API) in detail. Different forms of Hemoclar DMFs exist exist since differing nations have different regulations, such as Hemoclar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hemoclar DMF submitted to regulatory agencies in the US is known as a USDMF. Hemoclar USDMF includes data on Hemoclar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hemoclar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hemoclar 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 Hemoclar Drug Master File in Korea (Hemoclar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hemoclar. The MFDS reviews the Hemoclar KDMF as part of the drug registration process and uses the information provided in the Hemoclar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hemoclar 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 Hemoclar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hemoclar suppliers with KDMF on PharmaCompass.
A Hemoclar written confirmation (Hemoclar WC) is an official document issued by a regulatory agency to a Hemoclar manufacturer, verifying that the manufacturing facility of a Hemoclar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hemoclar APIs or Hemoclar finished pharmaceutical products to another nation, regulatory agencies frequently require a Hemoclar WC (written confirmation) as part of the regulatory process.
click here to find a list of Hemoclar 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 Hemoclar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hemoclar 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 Hemoclar 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 Hemoclar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hemoclar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hemoclar suppliers with NDC on PharmaCompass.
Hemoclar 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 Hemoclar GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Hemoclar GMP manufacturer or Hemoclar GMP API supplier for your needs.
A Hemoclar CoA (Certificate of Analysis) is a formal document that attests to Hemoclar's compliance with Hemoclar specifications and serves as a tool for batch-level quality control.
Hemoclar CoA mostly includes findings from lab analyses of a specific batch. For each Hemoclar 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.
Hemoclar may be tested according to a variety of international standards, such as European Pharmacopoeia (Hemoclar EP), Hemoclar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hemoclar USP).
