Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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Aspen API. More than just an APIâ„¢
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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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 : 2020-04-03
Pay. Date : 2019-02-01
DMF Number : 33336
Submission : 2019-02-08
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.
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...
Aspen API. More than just an APIâ„¢
About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...
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 ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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, ...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
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...
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DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BAS...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
USFDA APPLICATION NUMBER - 215395
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
USFDA APPLICATION NUMBER - 215395
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
USFDA APPLICATION NUMBER - 215395
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BAS...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
USFDA APPLICATION NUMBER - 22074
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
USFDA APPLICATION NUMBER - 22074
DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
USFDA APPLICATION NUMBER - 22074
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Lanreotide 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 Lanreotide Acetate manufacturer or Lanreotide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lanreotide Acetate manufacturer or Lanreotide Acetate supplier.
PharmaCompass also assists you with knowing the Lanreotide Acetate API Price utilized in the formulation of products. Lanreotide Acetate API Price is not always fixed or binding as the Lanreotide Acetate Price is obtained through a variety of data sources. The Lanreotide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lanreotide Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanreotide Acetate, including repackagers and relabelers. The FDA regulates Lanreotide Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanreotide 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 Lanreotide Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lanreotide Acetate supplier is an individual or a company that provides Lanreotide Acetate active pharmaceutical ingredient (API) or Lanreotide Acetate finished formulations upon request. The Lanreotide Acetate suppliers may include Lanreotide Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Lanreotide Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lanreotide Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanreotide Acetate active pharmaceutical ingredient (API) in detail. Different forms of Lanreotide Acetate DMFs exist exist since differing nations have different regulations, such as Lanreotide Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lanreotide Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Lanreotide Acetate USDMF includes data on Lanreotide Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanreotide Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lanreotide Acetate suppliers with USDMF 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 Lanreotide Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lanreotide 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 Lanreotide 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 Lanreotide Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lanreotide Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lanreotide Acetate suppliers with NDC on PharmaCompass.
Lanreotide 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 Lanreotide 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 Lanreotide Acetate GMP manufacturer or Lanreotide Acetate GMP API supplier for your needs.
A Lanreotide Acetate CoA (Certificate of Analysis) is a formal document that attests to Lanreotide Acetate's compliance with Lanreotide Acetate specifications and serves as a tool for batch-level quality control.
Lanreotide Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Lanreotide 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.
Lanreotide Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Lanreotide Acetate EP), Lanreotide Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lanreotide Acetate USP).
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