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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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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 : 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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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Certificate Number : CEP 2020-229 - Rev 02
Status : Valid
Issue Date : 2026-02-23
Type : Chemical
Substance Number : 2414
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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 : Bachem, with over 50 years of experience, supplies products for research, clinical development, and commercial use to pharmaceutical and biotechnology companies worldwide. It has e...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
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 APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
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 legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
About the Company : Vtides Life Sciences Pvt Ltd specializes in the design and synthesis of complex peptides using advanced chemical approaches, including microwave-assisted solid-phase synthesis. The...
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...
ApiSyn: From early-phase research and process development to reliable cGMP manufacturing worldwide.
About the Company : Operational since 2024, ApiSyn Healthcare Pvt. Ltd. is a rapidly growing cGMP manufacturer and CDMO specializing in APIs, intermediates, peptides, and amino acids across two dedica...
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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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ABOUT THIS PAGE
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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 Octreotide Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Octreotide Acetate, including repackagers and relabelers. The FDA regulates Octreotide Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Octreotide Acetate 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 Octreotide Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Octreotide Acetate supplier is an individual or a company that provides Octreotide Acetate active pharmaceutical ingredient (API) or Octreotide Acetate finished formulations upon request. The Octreotide Acetate suppliers may include Octreotide Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Octreotide Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Octreotide Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Octreotide Acetate active pharmaceutical ingredient (API) in detail. Different forms of Octreotide Acetate DMFs exist exist since differing nations have different regulations, such as Octreotide Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Octreotide Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Octreotide Acetate USDMF includes data on Octreotide Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Octreotide Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Octreotide Acetate 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 Octreotide Acetate Drug Master File in Japan (Octreotide Acetate JDMF) empowers Octreotide Acetate 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 Octreotide Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Octreotide Acetate 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 Octreotide Acetate 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 Octreotide Acetate Drug Master File in Korea (Octreotide Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Octreotide Acetate. The MFDS reviews the Octreotide Acetate KDMF as part of the drug registration process and uses the information provided in the Octreotide Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Octreotide Acetate 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 Octreotide Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Octreotide Acetate suppliers with KDMF on PharmaCompass.
A Octreotide Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Octreotide Acetate Certificate of Suitability (COS). The purpose of a Octreotide Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Octreotide Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Octreotide Acetate to their clients by showing that a Octreotide Acetate CEP has been issued for it. The manufacturer submits a Octreotide Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Octreotide Acetate CEP holder for the record. Additionally, the data presented in the Octreotide Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Octreotide Acetate DMF.
A Octreotide Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Octreotide Acetate 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 Octreotide Acetate suppliers with CEP (COS) on PharmaCompass.
A Octreotide Acetate written confirmation (Octreotide Acetate WC) is an official document issued by a regulatory agency to a Octreotide Acetate manufacturer, verifying that the manufacturing facility of a Octreotide Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Octreotide Acetate APIs or Octreotide Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Octreotide Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Octreotide Acetate 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 Octreotide Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Octreotide Acetate 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 Octreotide Acetate 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 Octreotide Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Octreotide Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Octreotide Acetate suppliers with NDC on PharmaCompass.
Octreotide Acetate 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 Octreotide Acetate 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 Octreotide Acetate GMP manufacturer or Octreotide Acetate GMP API supplier for your needs.
A Octreotide Acetate CoA (Certificate of Analysis) is a formal document that attests to Octreotide Acetate's compliance with Octreotide Acetate specifications and serves as a tool for batch-level quality control.
Octreotide Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Octreotide Acetate 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.
Octreotide Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Octreotide Acetate EP), Octreotide Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Octreotide Acetate USP).
