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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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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- INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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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 LAR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sandostatin LAR, including repackagers and relabelers. The FDA regulates Sandostatin LAR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sandostatin LAR 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 LAR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sandostatin LAR supplier is an individual or a company that provides Sandostatin LAR active pharmaceutical ingredient (API) or Sandostatin LAR finished formulations upon request. The Sandostatin LAR suppliers may include Sandostatin LAR API manufacturers, exporters, distributors and traders.
click here to find a list of Sandostatin LAR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sandostatin LAR DMF (Drug Master File) is a document detailing the whole manufacturing process of Sandostatin LAR active pharmaceutical ingredient (API) in detail. Different forms of Sandostatin LAR DMFs exist exist since differing nations have different regulations, such as Sandostatin LAR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sandostatin LAR DMF submitted to regulatory agencies in the US is known as a USDMF. Sandostatin LAR USDMF includes data on Sandostatin LAR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sandostatin LAR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sandostatin LAR 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 LAR Drug Master File in Japan (Sandostatin LAR JDMF) empowers Sandostatin LAR 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 LAR JDMF during the approval evaluation for pharmaceutical products. At the time of Sandostatin LAR 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 LAR 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 LAR Drug Master File in Korea (Sandostatin LAR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sandostatin LAR. The MFDS reviews the Sandostatin LAR KDMF as part of the drug registration process and uses the information provided in the Sandostatin LAR KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sandostatin LAR 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 LAR API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sandostatin LAR suppliers with KDMF on PharmaCompass.
A Sandostatin LAR CEP of the European Pharmacopoeia monograph is often referred to as a Sandostatin LAR Certificate of Suitability (COS). The purpose of a Sandostatin LAR CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sandostatin LAR EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sandostatin LAR to their clients by showing that a Sandostatin LAR CEP has been issued for it. The manufacturer submits a Sandostatin LAR CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sandostatin LAR CEP holder for the record. Additionally, the data presented in the Sandostatin LAR CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sandostatin LAR DMF.
A Sandostatin LAR CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sandostatin LAR 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 LAR suppliers with CEP (COS) on PharmaCompass.
A Sandostatin LAR written confirmation (Sandostatin LAR WC) is an official document issued by a regulatory agency to a Sandostatin LAR manufacturer, verifying that the manufacturing facility of a Sandostatin LAR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sandostatin LAR APIs or Sandostatin LAR finished pharmaceutical products to another nation, regulatory agencies frequently require a Sandostatin LAR WC (written confirmation) as part of the regulatory process.
click here to find a list of Sandostatin LAR 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 LAR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sandostatin LAR 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 LAR 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 LAR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sandostatin LAR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sandostatin LAR suppliers with NDC on PharmaCompass.
Sandostatin LAR 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 LAR 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 LAR GMP manufacturer or Sandostatin LAR GMP API supplier for your needs.
A Sandostatin LAR CoA (Certificate of Analysis) is a formal document that attests to Sandostatin LAR's compliance with Sandostatin LAR specifications and serves as a tool for batch-level quality control.
Sandostatin LAR CoA mostly includes findings from lab analyses of a specific batch. For each Sandostatin LAR 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 LAR may be tested according to a variety of international standards, such as European Pharmacopoeia (Sandostatin LAR EP), Sandostatin LAR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sandostatin LAR USP).
