Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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JDMF
NDC
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
ASMF
Mesochem is focused on incessant innovation along with the R&D of new APIs.
Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
Together we can improve the quality of life
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
NDC
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USDMF
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-19
Pay. Date : 2019-09-19
DMF Number : 34145
Submission : 2019-09-27
Status :
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16760
Submission : 2003-08-13
Status :
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38662
Submission : 2023-10-23
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-27
Pay. Date : 2012-11-09
DMF Number : 17777
Submission : 2004-10-21
Status :
Type : II
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API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - EQ 0.05MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.05MG BASE/ML
USFDA APPLICATION NUMBER - 19667
DOSAGE - INJECTABLE;INJECTION - EQ 0.1MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.1MG BASE/ML
USFDA APPLICATION NUMBER - 19667
DOSAGE - INJECTABLE;INJECTION - EQ 0.2MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19667
DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE/ML
USFDA APPLICATION NUMBER - 19667
DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19667
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)
USFDA APPLICATION NUMBER - 213224
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Chewable & Orodispersible Aids
Direct Compression
Taste Masking
Parenteral
Disintegrants & Superdisintegrants
Co-Processed Excipients
Granulation
API Stability Enhancers
Thickeners and Stabilizers
Solubilizers
Topical
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Octreotide Acetate 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 Octreotide Acetate manufacturer or Octreotide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Octreotide Acetate manufacturer or Octreotide Acetate supplier.
PharmaCompass also assists you with knowing the Octreotide Acetate API Price utilized in the formulation of products. Octreotide Acetate API Price is not always fixed or binding as the Octreotide Acetate Price is obtained through a variety of data sources. The Octreotide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sandostatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sandostatin, including repackagers and relabelers. The FDA regulates Sandostatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sandostatin 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 Sandostatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sandostatin supplier is an individual or a company that provides Sandostatin active pharmaceutical ingredient (API) or Sandostatin finished formulations upon request. The Sandostatin suppliers may include Sandostatin API manufacturers, exporters, distributors and traders.
click here to find a list of Sandostatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sandostatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Sandostatin active pharmaceutical ingredient (API) in detail. Different forms of Sandostatin DMFs exist exist since differing nations have different regulations, such as Sandostatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sandostatin DMF submitted to regulatory agencies in the US is known as a USDMF. Sandostatin USDMF includes data on Sandostatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sandostatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sandostatin 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 Sandostatin Drug Master File in Japan (Sandostatin JDMF) empowers Sandostatin 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 Sandostatin JDMF during the approval evaluation for pharmaceutical products. At the time of Sandostatin 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 Sandostatin 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 Sandostatin Drug Master File in Korea (Sandostatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sandostatin. The MFDS reviews the Sandostatin KDMF as part of the drug registration process and uses the information provided in the Sandostatin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sandostatin 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 Sandostatin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sandostatin suppliers with KDMF on PharmaCompass.
A Sandostatin CEP of the European Pharmacopoeia monograph is often referred to as a Sandostatin Certificate of Suitability (COS). The purpose of a Sandostatin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sandostatin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sandostatin to their clients by showing that a Sandostatin CEP has been issued for it. The manufacturer submits a Sandostatin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sandostatin CEP holder for the record. Additionally, the data presented in the Sandostatin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sandostatin DMF.
A Sandostatin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sandostatin 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 Sandostatin suppliers with CEP (COS) on PharmaCompass.
A Sandostatin written confirmation (Sandostatin WC) is an official document issued by a regulatory agency to a Sandostatin manufacturer, verifying that the manufacturing facility of a Sandostatin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sandostatin APIs or Sandostatin finished pharmaceutical products to another nation, regulatory agencies frequently require a Sandostatin WC (written confirmation) as part of the regulatory process.
click here to find a list of Sandostatin 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 Sandostatin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sandostatin 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 Sandostatin 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 Sandostatin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sandostatin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sandostatin suppliers with NDC on PharmaCompass.
Sandostatin 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 Sandostatin 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 Sandostatin GMP manufacturer or Sandostatin GMP API supplier for your needs.
A Sandostatin CoA (Certificate of Analysis) is a formal document that attests to Sandostatin's compliance with Sandostatin specifications and serves as a tool for batch-level quality control.
Sandostatin CoA mostly includes findings from lab analyses of a specific batch. For each Sandostatin 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.
Sandostatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Sandostatin EP), Sandostatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sandostatin USP).
