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API SUPPLIERS
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USDMF
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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
About the Company : With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology comp...
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, ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Space Peptides Pharmaceutical delivers Peptide CRDMO Services at Premium Speed & Quality to transform healthcare worldwide.
About the Company : Space Peptides Pharmaceutical is a Swiss Chinese company headquartered in Bern, Switzerland. We specialize in offering a complete range of pharmaceutical peptide CDMO services alon...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Atosiban 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 Atosiban manufacturer or Atosiban supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atosiban manufacturer or Atosiban supplier.
PharmaCompass also assists you with knowing the Atosiban API Price utilized in the formulation of products. Atosiban API Price is not always fixed or binding as the Atosiban Price is obtained through a variety of data sources. The Atosiban Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Atosiban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atosiban, including repackagers and relabelers. The FDA regulates Atosiban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atosiban 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 Atosiban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atosiban supplier is an individual or a company that provides Atosiban active pharmaceutical ingredient (API) or Atosiban finished formulations upon request. The Atosiban suppliers may include Atosiban API manufacturers, exporters, distributors and traders.
click here to find a list of Atosiban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atosiban DMF (Drug Master File) is a document detailing the whole manufacturing process of Atosiban active pharmaceutical ingredient (API) in detail. Different forms of Atosiban DMFs exist exist since differing nations have different regulations, such as Atosiban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atosiban DMF submitted to regulatory agencies in the US is known as a USDMF. Atosiban USDMF includes data on Atosiban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atosiban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atosiban 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 Atosiban Drug Master File in Korea (Atosiban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atosiban. The MFDS reviews the Atosiban KDMF as part of the drug registration process and uses the information provided in the Atosiban KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atosiban 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 Atosiban API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atosiban suppliers with KDMF on PharmaCompass.
A Atosiban written confirmation (Atosiban WC) is an official document issued by a regulatory agency to a Atosiban manufacturer, verifying that the manufacturing facility of a Atosiban active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atosiban APIs or Atosiban finished pharmaceutical products to another nation, regulatory agencies frequently require a Atosiban WC (written confirmation) as part of the regulatory process.
click here to find a list of Atosiban suppliers with Written Confirmation (WC) on PharmaCompass.
Atosiban 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 Atosiban 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 Atosiban GMP manufacturer or Atosiban GMP API supplier for your needs.
A Atosiban CoA (Certificate of Analysis) is a formal document that attests to Atosiban's compliance with Atosiban specifications and serves as a tool for batch-level quality control.
Atosiban CoA mostly includes findings from lab analyses of a specific batch. For each Atosiban 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.
Atosiban may be tested according to a variety of international standards, such as European Pharmacopoeia (Atosiban EP), Atosiban JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atosiban USP).
