IND submission is a major milestone in the life of your drug. We can provide all supporting analytical data to help ensure a smooth application process.
We have the expertise, flexibility, and resources to provide a full range of pharmaceutical API custom development services at every stage of the lifecycle.
We can provide lab-, kilo- and pilot-scale manufacturing for preclinical studies and all phases of clinical trials, supplying milligram to kilogram quantities.
Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. From our sites in Italy, Sweden, and the USA, we are a leading global supplier of generic APIs.
Drug substance tech transfer sounds so simple on the surface, but it’s a complex activity carrying a number of technical, regulatory, and quality risks.
At Cambrex, we provide a range of technologies equipped to solve your API manufacturing challenges, and we are flexible enough to handle the most complex molecules.
If you’re looking to outsource drug product development to a CDMO, you need a collaborative partner who will engage you deeply to understand the unique needs of your project.
From pre-formulation to commercial manufacturing and packaging, you can trust Cambrex to deliver your complex dosage forms with the perfect combination of technology, expertise, and collaboration.
At Cambrex, we offer a tried and trusted approach to technology transfer, for scale-up or when transitioning to a different facility.
We are equipped to take on projects at any size or scale, offering established pediatric formulation and development expertise and to-scale manufacturing capabilities.
Biopharma companies at all stages of development, rely on our expertise and broad capabilities to produce the clinical trial supply of drug products they need, when they need them.
We can support you, at any size or stage, with a range of primary and secondary packaging solutions.
You can rely on our extensive portfolio of analytical development solutions and testing services to rapidly advance your molecule for the greatest chance of success.
Cambrex offers a comprehensive suite of testing services for complex biopharmaceuticals including standalone analytical R&D, method validation, release testing, ICH stability, and routine QC testing.
We’re solid state chemistry experts who can deliver timely, phase-appropriate solutions to optimize the physical stability of your API, develop a more bioavailable formulation or overcome other challenges.
Cambrex’s experienced analysts are well-equipped to ensure microbial testing is of the highest quality for our customers and delivered with a quick and reliable turnaround.
Cambrex and Q1 Scientific’s stability storage and sample management capabilities provide a variety of pharmaceutical storage conditions, with walk-in and reach-in chambers that meet all ICH Q1A requirements.
Cambrex is here to support you in early-phase development. Our development experts apply their ingenuity and skill to address your unique challenges.
Our teams of creative problem-solvers work closely with you to accelerate drug development timelines, optimize processes, and meet regulatory requirements.
We understand that the commercial phase of drug development can be challenging, especially when it comes to manufacturing at scale and meeting changing market demands.
Cambrex is a leading global supplier of more than 70 generic APIs, as well as intermediates and derivatives.
Through innovative science and manufacturing excellence, we enable our customers to improve quality of life for their patients throughout the world, while creating value for our employees and shareholders
At Cambrex, we live and work by a set of core values that guide our actions and decision making.
At Cambrex, we are committed to being a leader in corporate responsibility. This commitment is embodied in not only our direct operations, but also in being a catalyst for positive change in global environmental sustainability, health and safety, labor and employment rights, business ethics and social responsibility, and global trade practices. As a supplier selected by Cambrex, we expect that you will adhere to this Code of Conduct and operate at a minimum in full compliance with the laws and regulations of all countries in which you operate. Those suppliers sourced directly by Cambrex customers are also expected to have programs in place which align with these Principles. Failure to comply with internationally recognized standards and the expectations outlined in this Supplier Code of Conduct may result in termination of any existing supply agreements as well as any further business opportunities with Cambrex.
In all we do, Cambrex acts with integrity and honesty and always maintains the highest standards for business responsibility in accordance with laws and ethical principles. As our supplier, you must adhere to the same principles.
You shall not violate antitrust and competition laws in the countries in which you operate and you must operate fairly and shall not engage in price fixing, price discrimination, or unfair trade practices that violate applicable antitrust and competition laws.
You must act ethically in business transactions and comply with anti-corruption laws and regulations. You shall not give or accept bribes or kick-backs, nor violate applicable bribery and corruption laws including the Foreign Corrupt Practices Act. Cambrex maintains policies concerning gifts and gratuities involving Cambrex employees and representatives and you shall in all respects comply with those policies. Any form of extortion, corruption, or embezzlement is strictly prohibited and will result in immediate termination of any existing supply agreements.
You must do business in a way that is open, transparent and with the highest integrity. A potential conflict of interest exists if a supplier’s employee or his or her family member has a close relationship with a Cambrex employee who can make decisions which affect the supplier’s business. You are required to immediately disclose these types of relationships to Cambrex prior to commencing business or whenever they arise.
You are required to have an established information security system to protect Cambrex’ information – and the information of its customers and employees – from being disclosed, changed, destroyed or used for any purpose other than the purpose for which it was provided.
You must accurately record and disclose information regarding your business activities, company structure, financial situation, and business performance in accordance with prevailing industry practices and applicable laws and regulations.
You must respect intellectual property rights and maintain controls to safeguard Cambrex’ name, logo, trademarks, confidential information, and other intellectual property against unauthorized use, modification and damage.
You shall have appropriate licenses, registrations, and certifications required to conduct business in the locations in which they operate.
You must operate ethically when making business decisions. You are expected to develop or adapt existing business practices in order to improve your work environment, community and society in general.
You should support opportunities for small and diverse-owned businesses, including, for example, those owned by minorities or others who are socially disadvantaged. A socially disadvantaged person is anyone likely to be subjected to gender, racial, or ethnic prejudice or cultural bias in society because of the individual’s identity as a member of a certain group stemming from circumstances beyond their control.
Cambrex believes in treating people with dignity and respect and is committed to protecting the human rights of others. As a global company, Cambrex is committed to maintaining safe and professional work environments where employees are free from violence, harassment and discrimination. We expect you to do the same.
Cambrex recognizes that your work force may have rights to form and/or join unions and bargain collectively. You shall not retaliate or discriminate against any person in your work force choosing to exercise their right to do so.
You shall comply with the terms and conditions of any and all purchase orders, contracts and General Terms and Conditions presented by Cambrex. This Supplier Code of Conduct, once accepted by you shall constitute a part of any relationship between Cambrex and you.
You shall not use, engage in or support child labor practices. Your labor force, including but not limited to employees and contract labor, shall not include a person under the age of 15, the local minimum working age or local the age of compulsory education (whichever is higher). Young people under the age of 18, legally able to work, should not carry out any hazardous work (chemical handling, strenuous physical labor, etc.) or night shifts, and all applicable local laws must be followed, including access to education, training, health checks and number of hours allowed to work, etc.
You shall not engage in or support forced or compulsory labor practices including bonded, indentured or involuntary prison labor, slavery, or human trafficking. No worker shall pay for a job or be denied freedom of movement. All work performed must be voluntary, and employees have the right to terminate employment with reasonable notice.
You must provide employees with wages and benefits that meet the minimum required amount by applicable laws/regulations. In countries where no minimum wage law applies, your labor force, including but not limited to employees and contract labor, must be paid at a rate comparable to the prevailing industry average and in all instances your labor force, including but not limited to employees and contract labor, shall be paid in legal tender, on a regular basis and in a timely manner.
You must comply with all applicable laws and industry standards on the amount of hours an employee or contract laborer can work in a successive shift, day, week or specific period of time. If applicable law does not set forth the maximum number of hours a person is allowed to work in a specified period of time, then no workweek shall exceed 60 hours, and you are required to pay standard pay and any premium rate as determined by national law or industry average, for overtime hours worked. You must also comply with national laws on public holidays and sick leave provisions.
You shall provide fair treatment to employees and create a work environment free from mental or physical coercion. You shall not engage in harsh or inhumane treatment of employees including workplace, sexual, psychological, racial, or religious harassment. Any act creating an intimidating, hostile or offensive work environment is strictly prohibited.
You shall not discriminate against employees based on race, color, age, gender, gender identity or expression, pregnancy, national origin, ethnicity, religion, gender, disability, sexual orientation, union membership, marital status, political opinion or any other protected category as defined by local law. Any exclusions or preferences in the work environment made on these bases, which results in impaired equality, are prohibited. Suppliers are expected to hire employees and contract labor based only on each person’s job-related competence and, if requested, must be able to provide to Cambrex a written policy statement on the prevention of discrimination in the workplace.
Cambrex believes in the value of diversity and is committed to actively creating an environment where each person is empowered to learn, grow and maximize his or her personal contribution. Celebrating the similarities and difference that shape each person will continue to encourage innovative thinking and drive the kind of sustainable, competitive advantage that will help you and Cambrex grow and prosper. You must be inclusive and ensure that your labor force and other stakeholders are always treated with dignity and respect.
Cambrex is required by law to track and disclose the use of certain minerals known as “conflict minerals.” Conflict minerals are tin, tungsten, tantalum and gold which are mined in conditions of armed conflict and human rights abuses in the Democratic Republic of Congo (DRC) and its adjacent countries. Those minerals used in our products must come from conflict-free sources. You are required to supply information about the use of these minerals in products sold to Cambrex upon commencement of business or as requested.
Our strong commitment to the environment, health and safety underpins all that we do at Cambrex. We are focused on the health and safety of our employees, customers, communities, and everyone impacted by our activities or products. We adhere to the highest health and safety standards, follow a safety first policy and always operate preventively to avoid accidents and injuries. We are an integral part of every community in which we operate and have an unwavering commitment to protect our natural resources. We expect you to share a similar passion for environmental stewardship and workplace safety.
You must comply with all environmental laws and regulations, and have applicable environmental permits and registrations for the business in which you operate. You must comply with the provisions of all permits and registrations held. All permits and registrations must be maintained and kept current.
The rights and title to property and land of the individual, indigenous people and local communities shall be respected. All negotiations with regard to their property or land, including the use of and transfers of it, must adhere to the principles of free, prior and informed consent, contract transparency and disclosure.
You shall assess the environmental impacts of your operations and implement active measures to reduce those on aspects including natural resource consumption, material sourcing, waste generation, wastewater discharges, air emissions, carbon footprint, prevention of accidental releases of hazardous materials into the environment and adverse environmental impacts on the local community. Wastewater, solid waste and hazardous air emissions shall be characterized, monitored, controlled and treated as required prior to discharge or disposal. Improvement efforts shall be continual.
You shall have processes and systems in place to prevent and mitigate accidental and diffusive spills and releases to the environment. You shall remedy any impacts that are caused.
You shall maintain the workplace and any living quarters used to house employees in a clean, orderly and safe manner and in full compliance with all applicable national laws and/or industry standards. You shall protect workers from over exposure to chemical, biological and physical hazards and physically demanding tasks, and implement programs to manage processes safely and prevent catastrophic events. You shall identify and encourage programs that promote access to health programs that positively affect the health of employees, and provide occupational health and safety training to all relevant employees. Workers shall not be disciplined for raising safety concerns and shall have the right to refuse unsafe working conditions, without fear of reprisal, until management adequately addresses their concerns.
You shall have programs and systems in place to provide workers with safety information relating to hazardous materials and education to protect them from potential hazards. Hazardous materials can include but are not limited to raw materials, isolated intermediates, products, solvents, cleaning agents and wastes.
You shall have programs and systems in place to communicate relevant hazard information of products to downstream users, including Cambrex.
You shall identify potential emergency situations, implement preventative measures and be prepared to execute emergency response plans. You shall have or establish emergency plans and response procedures to anticipate, identify, and respond to emergency situations and events.
We deliver quality in every aspect of our work, across all of our facilities, systems and teams. Whether we’re in the early stages of development or the final manufacturing process, we ensure that everything we do is to an exceptionally high standard. We are passionate about ensuring quality in all parts of the process, delivering a high-quality product every time.
You shall provide high-quality products that meet the requirements and specifications set forth by Cambrex. You shall create and maintain a Quality Management System (QMS) that is approved by a reputable third party and be able to provide documentation of quality certificates.
You shall promptly report quality issues, quality concerns or quality nonconformities that were supplied to Cambrex in error, or in the event that a latent issue, concern or non-conformity was detected after the material was shipped.
You shall communicate changes to your product, process and/or service with Cambrex in a timely manner. Generally, minor changes require prior notification to and major changes require prior approval from Cambrex. This obligation varies depending on the type of goods supplied. Your Cambrex purchasing agent will advise you of the change communication requirements in coordination with Cambrex Technical and/or Quality management based on your commodity or service.
Cambrex utilizes management systems to facilitate continuous improvement and compliance with these standards. Suppliers must also maintain a structured management system to ensure quality of product supplied to Cambrex as well as compliance with the standards outlined in this Code of Conduct. The management system should be verified through a combination of internal and/or third party audits. Elements of an effective management system include:
You shall demonstrate commitment to the concepts described in this document by allocating appropriate resources and identifying senior responsible personnel. The use of KPIs and targets are encouraged to measure and drive continuous improvement.
You shall identify and comply with applicable laws, regulations, standards and relevant customer requirements.
You shall have mechanisms to determine and manage risk in all areas addressed by this document.
You shall maintain documentation necessary to demonstrate conformance with these standards and compliance with applicable regulations.
You shall properly educate your employees so that they may safety perform their duties and make ethical decisions in compliance with laws, regulations and contract requirements.
You are expected to continually improve by setting performance objectives, executing implementation plans and taking necessary corrective actions for deficiencies identified by internal or external assessments, audits, inspections and management reviews.
All workers shall be encouraged to report concerns, illegal activities or breaches of these Principles in the workplace without threat of or actual reprisal, intimidation or harassment. You shall investigate and take corrective action if needed.
You shall have effective systems to communicate these Principles as well as all applicable regulatory requirements to workers, contractors and suppliers.
You should have Business Continuity measures in place for products and services being provided to Cambrex, in the case of a disruptive incident. You should proactively advise Cambrex of known issues that may lead to supply interruptions.
Cambrex complies with all applicable laws and regulations concerning embargoes and sanctions and does not, directly or indirectly, conduct transactions with individuals, entities, or countries that are the subject of restricted party or embargoed country lists (also known as interdiction lists). Suppliers to Cambrex are expected to follow a similar practice.
You shall identify and comply with applicable trade sanctions and export control laws, including but not limited to US, EU and Canadian trade sanction laws. You shall not directly or indirectly provide to Cambrex any material or service from a country, person or entity that is subject to regional, unilateral, and multilateral regulations that restrict transactions with specific foreign entities, persons or countries (often referred to as denied, debarred, and/or restricted parties). Examples of countries are Syria, Cuba, Iran, Sudan and North Korea. Examples of entities and persons include, but are not limited to, terrorists, organizations that fund terrorists, and/or parties guilty of trade violations. Countries that maintain consolidated lists of financial sanctions targets include the United States, the European Union, Canada, the United Kingdom, and Japan.
You shall implement due diligence compliance practices to screen you employees, customers, suppliers, vendors, agents and other business associates, including all parties in each transaction such as banks, insurance companies, shipping lines, and freight forwarders to ensure compliance with applicable laws and regulations concerning embargoes and sanctions.
You shall comply with the trade regulation laws of the country or legal subdivision in which you operate.
You shall carry out due diligence on the source of critical raw materials to promote legal and sustainable sourcing.
Cambrex’ Supplier Code of Conduct outlines the expectations Cambrex has for its suppliers with respect to labor and employment rights, environmental health and safety, quality, ethics and social responsibility, and global trade practices.
Cambrex created a supplier code to communicate its expectations and help ensure suppliers operate responsibly and conduct business in a manner that aligns with our company’s principles and values.
Suppliers are responsible for establishing a management system that supports the intent and content of this code and monitors/records regulatory compliance. The verification process may include a follow-up request for information, including questionnaires as well as onsite audits.
If a supplier fails to meet the standards set forth in this document, the supplier should inform Cambrex of the known deficiency within a timely manner once identified. If the deficiency is identified through a Cambrex audit, the supplier will be notified of the deficiency. In either case, supplier will then need to submit to Cambrex an acceptable corrective action plan. If the plan is approved, the supplier will be given a reasonable period of time to resolve the area(s) of concern. Failure to remedy issues per the agreed upon corrective action plan or to communicate known issues to Cambrex within a timely manner may result in termination of the business relationship.
Suppliers in existing agreements will not have to renegotiate their terms with Cambrex; however, once the agreement is up for renewal, the Cambrex Supplier Code will be incorporated into the Terms and Conditions.
This Supplier Code of Conduct is effective immediately. If additional time is needed for existing suppliers to become compliant with this Code of Conduct, the supplier shall notify Cambrex of the situation and submit a list of compliance gaps along with a proposed correct action plan to address those gaps. If the plan is approved, the supplier will be given a reasonable period of time to resolve the area(s) of concern. Failure to remedy issues per the agreed upon corrective action plan or to communicate known issues to Cambrex within a timely manner may result in termination of the business relationship.
Should you have additional questions about this Supplier Code of Conduct please contact your Cambrex purchasing representative or email your questions to the requestor.
If you have any questions regarding our Supplier Code of Conduct, please contact us.
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