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API SUPPLIERS
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
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USDMF
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25827
Submission : 2012-02-22
Status :
Type : II
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SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Pentosan Polysulphate Sodium IH
Date of Issue : 2025-09-24
Valid Till : 2028-07-07
Written Confirmation Number : WC-0165
Address of the Firm : Plot No. A-1/2102 & 2103, Phase-III, G.I.D.C Vapi-396195, Valsad, Gujarat, India
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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...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded to improve lives, helps businesses expand in existing and emerging markets. With over 155 years of experience, it operates in 36 markets, is listed on the SIX Swiss E...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
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 : Originator
Registration Country : South Africa
Brand Name : Tavan-SP 54 Injection
Dosage Form : INJ
Dosage Strength : 100mg/ml
Packaging : 1X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Brand Name : Pentosan Polysulfate S...
Dosage Form : Gel
Dosage Strength : 1.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Brand Name : Pentosan Polysulfate S...
Dosage Form : Cream
Dosage Strength : 0.1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Brand Name : Pentosan Polysulfate S...
Dosage Form : Cream
Dosage Strength : 0.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Pentosan Polysulfate Sodium; Triamcinolone Acetonide; Lidocaine
Brand Name : Pentosan Polysulfate S...
Dosage Form : Ointment
Dosage Strength : 1%; 2%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Brand Name : Pentosan Polysulfate S...
Dosage Form : Capsule
Dosage Strength : 45MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Brand Name : Pentosan Polysulfate S...
Dosage Form : Injection
Dosage Strength : 90MG/1ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Brand Name : Pentosan Polysulfate S...
Dosage Form : Capsule
Dosage Strength : 45MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Brand Name : Pentosan Polysulfate S...
Dosage Form : Vial
Dosage Strength : 100MG/1ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Regulatory Info :
Registration Country : India
Brand Name : Pentosan Polysulfate S...
Dosage Form : Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
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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, Price,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.
PharmaCompass also assists you with knowing the Pentosan Polysulfate Sodium API Price utilized in the formulation of products. Pentosan Polysulfate Sodium API Price is not always fixed or binding as the Pentosan Polysulfate Sodium Price is obtained through a variety of data sources. The Pentosan Polysulfate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pentosan Polysulfate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentosan Polysulfate Sodium, including repackagers and relabelers. The FDA regulates Pentosan Polysulfate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentosan Polysulfate Sodium supplier is an individual or a company that provides Pentosan Polysulfate Sodium active pharmaceutical ingredient (API) or Pentosan Polysulfate Sodium finished formulations upon request. The Pentosan Polysulfate Sodium suppliers may include Pentosan Polysulfate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Pentosan Polysulfate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentosan Polysulfate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentosan Polysulfate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Pentosan Polysulfate Sodium DMFs exist exist since differing nations have different regulations, such as Pentosan Polysulfate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentosan Polysulfate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Pentosan Polysulfate Sodium USDMF includes data on Pentosan Polysulfate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentosan Polysulfate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium Drug Master File in Korea (Pentosan Polysulfate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pentosan Polysulfate Sodium. The MFDS reviews the Pentosan Polysulfate Sodium KDMF as part of the drug registration process and uses the information provided in the Pentosan Polysulfate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pentosan Polysulfate Sodium suppliers with KDMF on PharmaCompass.
A Pentosan Polysulfate Sodium written confirmation (Pentosan Polysulfate Sodium WC) is an official document issued by a regulatory agency to a Pentosan Polysulfate Sodium manufacturer, verifying that the manufacturing facility of a Pentosan Polysulfate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pentosan Polysulfate Sodium APIs or Pentosan Polysulfate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Pentosan Polysulfate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pentosan Polysulfate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pentosan Polysulfate Sodium suppliers with NDC on PharmaCompass.
Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium GMP manufacturer or Pentosan Polysulfate Sodium GMP API supplier for your needs.
A Pentosan Polysulfate Sodium CoA (Certificate of Analysis) is a formal document that attests to Pentosan Polysulfate Sodium's compliance with Pentosan Polysulfate Sodium specifications and serves as a tool for batch-level quality control.
Pentosan Polysulfate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Pentosan Polysulfate Sodium 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.
Pentosan Polysulfate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Pentosan Polysulfate Sodium EP), Pentosan Polysulfate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pentosan Polysulfate Sodium USP).
