CPL Sachse - CDMO/CMO
We are an established order and contract manufacturer of active pharmaceutical ingredients (drug substances) and selected intermediates ranging from milligrams to kilograms. Our production follows cGMP and is in accordance with the EU-GMP-Guideline Part II (ICH Q7). We are regularly inspected by the responsible local authority which issues us with drug substance-specific GMP certificates. We are currently manufacturing nine certified APIs for market supplies exclusively for our customers on a regular basis.
Synthesis development
We have more than 30 years of experience in the development of organic syntheses for drug substances (APIs). On receipt of an order for synthesis development, we first research the latest state-of-the-art and conduct a feasibility study if applicable. This includes the proposed synthetic route, a schedule, and...
Germany
Modern GMP facility
Team of academics and technical experts
Small to large batch sizes possible
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Service categories
Finished formulation / FDF
Ingredient
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Ingredient
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Contact Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH for Contract Services Expertise
Connect with Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH, a leading pharmaceutical company from Germany. They offer specialized CMO/CDMO - Contract (Development) Manufacturing Organizations, Analytical services, of which the services for CMO/CDMO include Oral Liquids, API, Intermediates. Contact Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH for free and discover if they are the perfect partner for your pharmaceutical needs.
CMO/CDMO - Contract (Development) Manufacturing Organizations
CDMOs and CMOs are pivotal in the pharmaceutical and biotech industries, offering specialized services in drug development and manufacturing. They assist in scaling up production from laboratory to commercial quantities, while adhering to strict regulatory standards. These organizations play a crucial role in the efficient and cost-effective production of medical and pharmaceutical products, ensuring quality and compliance at every stage.
Pharmaoffer's category for Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) encompasses a wide range of specialized services crucial to the pharmaceutical and biotech sectors. These organizations, often referred to as pharmaceutical CDMOs or drug CMOs, are instrumental in advancing drug development and manufacturing processes.
Key Functions of CMOs/CDMOs:
Drug Development and Manufacturing Expertise: Offering comprehensive services in drug development, from initial research and development to full-scale manufacturing. This includes CDMO services and CMO manufacturing, ensuring a seamless transition from concept to market.
Scalability Solutions: Assisting in scaling production from laboratory to commercial scale, meeting the demands of various projects while maintaining quality and efficiency. This is where the expertise of a full-service CDMO becomes invaluable.
Regulatory Compliance and Quality Assurance: Ensuring adherence to strict regulatory standards such as FDA and EMA guidelines, and implementing rigorous quality control measures throughout the manufacturing process. This includes operating within GMP certified facilities to guarantee the highest standards of production.
Cost-Effective Production: Providing efficient and cost-effective solutions for the production of medical and pharmaceutical products, enabling companies to focus on innovation and marketing. CMO contract manufacturing plays a key role in this aspect.
End-to-End Service Provision: From concept to commercialization, CMOs/CDMOs offer a range of services including process optimization, formulation development, clinical trial material production, and commercial manufacturing. This comprehensive approach is often referred to as Contract Development Manufacturing.
Connect with Leading CMOs/CDMOs
Through Pharmaoffer, you can explore and connect with a comprehensive range of CMOs/CDMOs. Our platform offers access to organizations that play a vital role in the efficient, quality-assured, and compliant production of pharmaceutical and medical products, supporting the industry's growth and innovation. Whether you're looking for a CDMO partner, CDMO solutions, or contract manufacturers in pharma, Pharmaoffer is your gateway to the best in the industry.
Analytical services
Analytical Services in the pharmaceutical industry play a crucial role in drug development and quality assurance. Understand how Analytical Services, including methods like HPLC, GC-MS, and spectroscopy, play a critical role in drug development and quality control. Discover their significance in adhering to regulatory standards such as FDA and EMA guidelines. Uncover the impact of Analytical Services on the pharmaceutical industry through our comprehensive insights, aiding in informed decision-making.
Pharmaoffer's platform provides access to providers of contract Analytical Services, a fundamental aspect of the pharmaceutical industry. These services, encompassing Pharmaceutical Analytical Services and Bioanalytical Services, are integral to drug development and quality control, ensuring adherence to regulatory standards and the efficacy and safety of pharmaceutical products.
Key Aspects of Contract Analytical Services:
Advanced Analytical Techniques: Utilization of sophisticated methods such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), and various spectroscopy techniques for accurate drug analysis. This is a cornerstone of services offered by analytical testing laboratories and Pharma Laboratories.
Regulatory Compliance: Ensuring that all analytical testing and processes meet the stringent guidelines set by regulatory bodies like the FDA and EMA. This includes GMP analytical testing, which is crucial for maintaining high standards in pharmaceutical analysis.
Quality Control and Assurance: Critical role in quality control and assurance, verifying the composition, purity, and potency of pharmaceutical products. Analytical Laboratory Services play a pivotal role in this process.
Support in Drug Development: Providing essential support in the drug development process, from early discovery through to clinical trials and commercialization. This includes chemical analytical services that are vital for comprehensive pharmaceutical research.
Informed Decision-Making: Aiding pharmaceutical companies in making informed decisions through comprehensive data and analysis provided by Pharmaceutical Analysis services.
Discover the Impact of Analytical Services
Through Pharmaoffer, you can explore and connect with specialized providers of contract Analytical Services. Our platform ensures access to services that are crucial for meeting the high standards of the pharmaceutical industry, supporting the entire lifecycle of drug development.
Finished formulation / FDF
Finished Formulation CMOs/CDMOs focus on the final stage of pharmaceutical product manufacturing, which involves blending and formulating active pharmaceutical ingredients (APIs) into finished dosage forms like tablets, capsules, liquid formulations, and injectables.
Pharmaoffer showcases a range of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) that specialize in Finished Formulation. These organizations, key players in FDF (Finished Dosage Formulations) manufacturing, are essential in the pharmaceutical industry, focusing on the final stage of product manufacturing – blending and formulating APIs into finished dosage forms.
Key Services Provided by Finished Formulation CMOs/CDMOs:
Diverse Dosage Form Production: Expertise in creating a wide array of finished dosage forms, including tablets, capsules, oral liquids, powders, and more. This service is a critical aspect of FDF CDMO offerings.
High-Quality Formulation Development: Developing formulations that ensure efficacy, stability, and patient acceptability, adhering to precise pharmaceutical standards. This includes specialized formulation services and CDMO formulation development.
Advanced Manufacturing Processes: Utilizing state-of-the-art manufacturing processes and equipment to produce high-quality finished pharmaceutical products. This is a key component of CDMO products and contract formulation services.
Regulatory Compliance and Quality Assurance: Ensuring all products meet stringent regulatory standards, including compliance with FDA, EMA, and other regulatory bodies’ guidelines.
Customized Manufacturing Solutions: Offering tailored solutions to meet the unique needs of different pharmaceutical products, from small-scale batches to large-scale commercial production. This flexibility is essential in the realm of FDF manufacturing.
Connect with Expert Finished Formulation Providers
Through Pharmaoffer, you can explore and connect with CMOs/CDMOs that specialize in Finished Formulation services. Our platform provides access to organizations equipped with the expertise and technology necessary for the efficient and compliant production of finished pharmaceutical products.
Ingredient
Ingredient CMOs/CDMOs specialize in the production of individual pharmaceutical ingredients, also known as active pharmaceutical ingredients (APIs) or drug substances. Their primary role is to synthesize, purify, and supply these chemical compounds in compliance with stringent quality standards.
Pharmaoffer's category for Ingredient Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) is dedicated to the production of individual pharmaceutical ingredients. These organizations, central to Pharmaceutical Ingredients Manufacturing, play a crucial role in synthesizing, purifying, and supplying active pharmaceutical ingredients (APIs) or drug substances, adhering to the highest standards of quality and compliance.
Key Services Provided by Ingredient CMOs/CDMOs:
API Synthesis and Production: Expertise in the synthesis of APIs, utilizing advanced chemical processes to produce high-purity pharmaceutical ingredients. This is a fundamental aspect of CDMO Ingredients services.
Stringent Quality and Purity Standards: Adherence to stringent quality and purity standards, ensuring that APIs meet all necessary pharmaceutical regulations and guidelines.
Supply Chain Reliability: Providing a reliable supply of essential pharmaceutical ingredients, crucial for the production of various medications.
Regulatory Compliance: Ensuring compliance with regulatory requirements, including FDA, EMA, and other global health authorities' standards.
Custom API Development: Offering tailored solutions for API development, addressing specific therapeutic needs and chemical properties.
Explore Specialized API Production Partners
Through Pharmaoffer, you can access a range of CMOs/CDMOs specializing in the production of pharmaceutical ingredients. Our platform connects you with providers who have the expertise and facilities necessary to produce APIs with the required purity, efficacy, and regulatory compliance.
Oral Liquids
Oral liquids like solutions, syrups, and suspensions are vital for patients with swallowing difficulties. Their manufacturing ensures homogeneity, palatability, and stability, offering precise dosing in pediatric and geriatric care. They span a range of therapeutic categories.
Pharmaoffer features Contract Development and Manufacturing Organizations (CDMOs) that excel in the production of oral liquids, such as solutions, syrups, and suspensions. These formulations are particularly important for patients who have difficulties swallowing pills, including pediatric and geriatric populations. This includes expertise in oral liquids manufacturing, liquid pharmaceutical manufacturing, and liquid contract manufacturing.
Key Services Provided by Our Listed CDMOs:
Homogeneous Formulations: Ensuring consistent homogeneity in oral liquid formulations for uniform dosing and efficacy. This is a key aspect of oral liquids CDMO services.
Enhanced Palatability: Development of oral liquids with improved taste and texture to enhance patient compliance, particularly crucial in pediatric care. This is essential in liquid pharmaceutical manufacturing.
Stability and Shelf-Life: Focusing on the stability of formulations to ensure the longevity and effectiveness of oral liquids over time.
Precise Dosing Solutions: Offering solutions that allow for precise and adjustable dosing, accommodating different patient needs and treatment regimens. This is a critical service in liquid contract manufacturing.
Wide Therapeutic Range: Production capabilities spanning a diverse range of therapeutic categories to address various health conditions with oral liquid formulations. This includes Oral Solids manufacturing capabilities.
Your Partner in Liquid Formulation Excellence
Through Pharmaoffer, you have access to CDMOs with specialized expertise in the development and manufacturing of oral liquids. Our platform connects you with partners who can provide high-quality, patient-friendly formulations for effective and convenient treatments.
API
APIs are the core of pharmaceutical products, determining the therapeutic efficacy. Their production involves complex synthesis, purification, and characterization processes, adhering to stringent regulatory standards. APIs are crucial in drug development for diverse medical conditions.
Pharmaoffer presents a comprehensive selection of Contract Development and Manufacturing Organizations (CDMOs) specializing in the production of Active Pharmaceutical Ingredients (APIs). Our platform caters to pharmaceutical professionals seeking expert services in API development and manufacturing, including API Manufacturing and API CDMO capabilities.
Key Services Provided by Our Listed CDMOs:
Complex Synthesis Capabilities: Expertise in intricate chemical synthesis processes, ensuring the production of high-quality APIs. This is a critical aspect of API production.
Rigorous Purification Processes: Advanced purification techniques to meet the highest purity standards essential for API efficacy and safety.
Detailed Characterization and Analysis: Thorough API characterization to ascertain structural integrity, stability, and compliance with pharmacopeial standards.
Compliance with Regulatory Requirements: Strict adherence to global regulatory guidelines, including FDA and EMA standards, ensuring the delivery of APIs that meet all necessary regulatory criteria.
Custom API Development: Tailored solutions for API development, catering to diverse therapeutic needs and specific drug formulations. This service is particularly important in the realm of Active Pharmaceutical Ingredients.
Your Ideal CDMO Partner for API Manufacturing
Pharmaoffer bridges the gap between pharmaceutical professionals and top CDMOs in the API sector. Whether it's for generic drugs or novel therapeutics, our listed CDMOs are equipped with the expertise and technology to support your API manufacturing needs, from small-scale lab production to large-scale commercial batches.
Intermediates
Intermediates are crucial in the pharmaceutical supply chain, representing stages in the synthesis of APIs. Their production requires precision and control, impacting the quality and availability of final pharmaceutical products, across various therapeutic areas.
Pharmaoffer's platform provides access to Contract Development and Manufacturing Organizations (CDMOs) proficient in producing pharmaceutical intermediates. These intermediates, essential components in the pharmaceutical supply chain, represent critical stages in the synthesis of Active Pharmaceutical Ingredients (APIs). This includes specialized services in Intermediates Manufacturing and Intermediates CDMO.
Key Services Provided by Our Listed CDMOs:
Precision in Intermediate Synthesis: Emphasis on precision and control in the synthesis processes, crucial for the quality of the final API. This is a key aspect of Intermediates Manufacturing.
Quality Assurance and Compliance: Stringent quality assurance protocols to ensure that intermediates meet all required standards and regulations. This is essential for any Intermediates CDMO.
Scalable Production Capacities: Ability to scale production of intermediates to match the demands of various pharmaceutical projects.
Wide Range of Intermediates: Production of a diverse array of intermediates, suitable for different therapeutic areas and drug formulations.
Collaborative Development Approach: Working closely with pharmaceutical companies to develop and produce intermediates that meet specific project requirements.
Connect with Intermediate Manufacturing Experts
Pharmaoffer connects you with CDMOs that have specialized expertise in the production of pharmaceutical intermediates. Our platform ensures you find the right partner capable of delivering high-quality intermediates, thereby impacting the efficacy and availability of final pharmaceutical products.