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API SUPPLIERS
Smithfield BioScience transforms bioproducts into trusted, life-saving therapies through safe, reliable U.S.-based manufacturing.
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NDC
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
JDMF
NDC
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API™
NDC
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Smithfield BioScience transforms bioproducts into trusted, life-saving therapies through safe, reliable U.S.-based manufacturing.
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USDMF
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Smithfield BioScience transforms bioproducts into trusted, life-saving therapies through safe, reliable U.S.-based manufacturing.
About the Company : Smithfield BioScience specializes in harvesting and repurposing porcine-derived biological materials for use in pharmaceuticals, medical devices, regenerative medicine, and nutrace...
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
About the Company : Bioiberica is a global Life Science company with more than 45 years' experience in the production and development of molecules of high biological and therapeutic value for the phar...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with over 26 years of expertise in human and veterinary pharmaceuticals. Operating in 40+ countries, we own two st...
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DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 10,000 UNITS/...DOSAGE - INJECTABLE;INJECTION - 10,000 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 100 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 20,000 UNITS/...DOSAGE - INJECTABLE;INJECTION - 20,000 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 40 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 50 UNITS/ML
USFDA APPLICATION NUMBER - 17029
DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 1,000 UNITS/ML
USFDA APPLICATION NUMBER - 201370
DOSAGE - INJECTABLE;INJECTION - 10,000 UNITS/...DOSAGE - INJECTABLE;INJECTION - 10,000 UNITS/ML
USFDA APPLICATION NUMBER - 201370
DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/M...DOSAGE - INJECTABLE;INJECTION - 5,000 UNITS/ML
USFDA APPLICATION NUMBER - 201370
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
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Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
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Digital Content
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08 Oct 2024
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REF. STANDARDS & IMPURITIES
EDQM
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ABOUT THIS PAGE
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PharmaCompass offers a list of Heparin 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 Heparin Sodium manufacturer or Heparin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Heparin Sodium manufacturer or Heparin Sodium supplier.
PharmaCompass also assists you with knowing the Heparin Sodium API Price utilized in the formulation of products. Heparin Sodium API Price is not always fixed or binding as the Heparin Sodium Price is obtained through a variety of data sources. The Heparin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CALCIPARINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CALCIPARINE, including repackagers and relabelers. The FDA regulates CALCIPARINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CALCIPARINE 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 CALCIPARINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CALCIPARINE supplier is an individual or a company that provides CALCIPARINE active pharmaceutical ingredient (API) or CALCIPARINE finished formulations upon request. The CALCIPARINE suppliers may include CALCIPARINE API manufacturers, exporters, distributors and traders.
click here to find a list of CALCIPARINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CALCIPARINE DMF (Drug Master File) is a document detailing the whole manufacturing process of CALCIPARINE active pharmaceutical ingredient (API) in detail. Different forms of CALCIPARINE DMFs exist exist since differing nations have different regulations, such as CALCIPARINE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CALCIPARINE DMF submitted to regulatory agencies in the US is known as a USDMF. CALCIPARINE USDMF includes data on CALCIPARINE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CALCIPARINE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CALCIPARINE 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 CALCIPARINE Drug Master File in Japan (CALCIPARINE JDMF) empowers CALCIPARINE 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 CALCIPARINE JDMF during the approval evaluation for pharmaceutical products. At the time of CALCIPARINE 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 CALCIPARINE 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 CALCIPARINE Drug Master File in Korea (CALCIPARINE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CALCIPARINE. The MFDS reviews the CALCIPARINE KDMF as part of the drug registration process and uses the information provided in the CALCIPARINE KDMF to evaluate the safety and efficacy of the drug.
After submitting a CALCIPARINE 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 CALCIPARINE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CALCIPARINE suppliers with KDMF on PharmaCompass.
A CALCIPARINE CEP of the European Pharmacopoeia monograph is often referred to as a CALCIPARINE Certificate of Suitability (COS). The purpose of a CALCIPARINE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CALCIPARINE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CALCIPARINE to their clients by showing that a CALCIPARINE CEP has been issued for it. The manufacturer submits a CALCIPARINE CEP (COS) as part of the market authorization procedure, and it takes on the role of a CALCIPARINE CEP holder for the record. Additionally, the data presented in the CALCIPARINE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CALCIPARINE DMF.
A CALCIPARINE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CALCIPARINE 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 CALCIPARINE 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 CALCIPARINE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CALCIPARINE 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 CALCIPARINE 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 CALCIPARINE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CALCIPARINE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CALCIPARINE suppliers with NDC on PharmaCompass.
CALCIPARINE 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 CALCIPARINE 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 CALCIPARINE GMP manufacturer or CALCIPARINE GMP API supplier for your needs.
A CALCIPARINE CoA (Certificate of Analysis) is a formal document that attests to CALCIPARINE's compliance with CALCIPARINE specifications and serves as a tool for batch-level quality control.
CALCIPARINE CoA mostly includes findings from lab analyses of a specific batch. For each CALCIPARINE 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.
CALCIPARINE may be tested according to a variety of international standards, such as European Pharmacopoeia (CALCIPARINE EP), CALCIPARINE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CALCIPARINE USP).
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