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API SUPPLIERS
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USDMF
Smithfield BioScience transforms bioproducts into trusted, life-saving therapies through safe, reliable U.S.-based manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-26
Pay. Date : 2014-04-03
DMF Number : 7944
Submission : 1989-03-02
Status :
Type : II
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31738
Submission : 2017-05-17
Status :
Type : II
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26680
Submission : 2013-01-07
Status :
Type : II
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2013-04-26
DMF Number : 17838
Submission : 2004-11-03
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9472
Submission : 1991-12-23
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-15
Pay. Date : 2020-09-14
DMF Number : 2712
Submission : 1976-08-03
Status :
Type : II
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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 pharmaceuticals, medical devices, regenerative medicine, and nutraceutica...
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 over 45 years of experience developing & producing high‑value biological molecules for the pharmaceutical and nutraceutical indus...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
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.
...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities...
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 - 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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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
29
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 Heparin Sodium Salt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparin Sodium Salt, including repackagers and relabelers. The FDA regulates Heparin Sodium Salt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparin Sodium Salt 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 Heparin Sodium Salt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Heparin Sodium Salt supplier is an individual or a company that provides Heparin Sodium Salt active pharmaceutical ingredient (API) or Heparin Sodium Salt finished formulations upon request. The Heparin Sodium Salt suppliers may include Heparin Sodium Salt API manufacturers, exporters, distributors and traders.
click here to find a list of Heparin Sodium Salt suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Heparin Sodium Salt DMF (Drug Master File) is a document detailing the whole manufacturing process of Heparin Sodium Salt active pharmaceutical ingredient (API) in detail. Different forms of Heparin Sodium Salt DMFs exist exist since differing nations have different regulations, such as Heparin Sodium Salt USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Heparin Sodium Salt DMF submitted to regulatory agencies in the US is known as a USDMF. Heparin Sodium Salt USDMF includes data on Heparin Sodium Salt's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Heparin Sodium Salt USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Heparin Sodium Salt 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 Heparin Sodium Salt Drug Master File in Japan (Heparin Sodium Salt JDMF) empowers Heparin Sodium Salt 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 Heparin Sodium Salt JDMF during the approval evaluation for pharmaceutical products. At the time of Heparin Sodium Salt 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 Heparin Sodium Salt 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 Heparin Sodium Salt Drug Master File in Korea (Heparin Sodium Salt KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Heparin Sodium Salt. The MFDS reviews the Heparin Sodium Salt KDMF as part of the drug registration process and uses the information provided in the Heparin Sodium Salt KDMF to evaluate the safety and efficacy of the drug.
After submitting a Heparin Sodium Salt 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 Heparin Sodium Salt API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Heparin Sodium Salt suppliers with KDMF on PharmaCompass.
A Heparin Sodium Salt CEP of the European Pharmacopoeia monograph is often referred to as a Heparin Sodium Salt Certificate of Suitability (COS). The purpose of a Heparin Sodium Salt CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Heparin Sodium Salt EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Heparin Sodium Salt to their clients by showing that a Heparin Sodium Salt CEP has been issued for it. The manufacturer submits a Heparin Sodium Salt CEP (COS) as part of the market authorization procedure, and it takes on the role of a Heparin Sodium Salt CEP holder for the record. Additionally, the data presented in the Heparin Sodium Salt CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Heparin Sodium Salt DMF.
A Heparin Sodium Salt CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Heparin Sodium Salt 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 Heparin Sodium Salt 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 Heparin Sodium Salt as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Heparin Sodium Salt 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 Heparin Sodium Salt 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 Heparin Sodium Salt and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Heparin Sodium Salt NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Heparin Sodium Salt suppliers with NDC on PharmaCompass.
Heparin Sodium Salt 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 Heparin Sodium Salt 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 Heparin Sodium Salt GMP manufacturer or Heparin Sodium Salt GMP API supplier for your needs.
A Heparin Sodium Salt CoA (Certificate of Analysis) is a formal document that attests to Heparin Sodium Salt's compliance with Heparin Sodium Salt specifications and serves as a tool for batch-level quality control.
Heparin Sodium Salt CoA mostly includes findings from lab analyses of a specific batch. For each Heparin Sodium Salt 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.
Heparin Sodium Salt may be tested according to a variety of international standards, such as European Pharmacopoeia (Heparin Sodium Salt EP), Heparin Sodium Salt JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Heparin Sodium Salt USP).
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