Proper sampling procedure

We have found that customers who follow a different sampling process may get different results. We encourage our customers always to follow proper sampling procedure to help ensure consistency in analytical results. For potent materials or other special products, we may provide additional sampling suggestions.

Proper sampling means that the sample is representative of the entire material. Powders are made of hundreds billions of crystals and their samples ought to statistically represent all the physical and chemical characteristics, and also any undesired characteristics.

It also means that the sample, and especially the product is not polluted during the sampling activity (this is called cross contamination). The sample should also be representative over time, so it must be properly packaged.  These fundamental expectations are achieved through detailed instruction, registration activities and control strategies.

There are four phases for an effective bulk sampling procedure:

1. 
   

   Prepare to take the sample

   
   

Advance preparation is essential for getting a high-quality sample to reduce the risk of foreign materials contaminating the sample or bulk product itself.

Sampling should take place in a standard GMP-certified powder handling suite which is a clean room or an isolator.

Access should not be direct. Passing through intermediate chambers (air locks) guarantees that the material reaches the clean area only after its external cleaning and the operators only after specific change of dressing.

Material and operators follow different paths — their entrance and exit are different. Each room has its own specific pressure that keeps out dust even when doors need to be opened. Inside the clean room or isolator, one drum is kept open each time and a specific cleaning is performed between different lots or different products.

Before opening the drums to be sampled, all tools and packaging material are set out. Tools and dresses are disposable. Temperature, humidity, entrance of materials and operators are under current registration.

2. 
   

   Collect the sample

   
   

The sample ought to be “composite”, which means obtained as a collection of small portions.

For the same drum, the sample is collected at the top, central and bottom of the powder inside it. For the same lot the single sample of each drum is collected. Then carefully and thoroughly, the entire powder collection is mixed, combining the material took from several places in each drum.

3. 
   

   Properly re-pack the bulk product

   
   

Properly re-packaging the bulk product is essential to maintaining product quality.

The internal and external bags in each drum need to be resealed, and if required, stabilizers need to be replaced (desiccants and/or oxygen scavengers) between the primary and secondary packaging. The drums are then returned to the proper storage place.

4. 
   

   Preserve the sample

   
   

The collected, representative sample is usually placed it in the same type of packaging used for the bulk product.

When it is not used for a stability test, sometimes additional secondary packaging, stabilizers or different primary packaging have been studied and found more appropriate for the sample packaging, so it is more stable to air and moisture. These precautions are taken before sending the sample to the lab.

What happens next?

The composite representative sample is used for release analysis. The entire lot is temporarily packed in production into one or more primary packages, depending on the lot size, and it’s then sent to the warehouse.

The final packaging for the API is done in the warehouse.

In case the customer requests that the API is dispensed in a specific unit-size, the initial packages are opened in the warehouse and the material is repacked into smaller packages, each with the proper weight. In addition, satellite samples are prepared.

Teva is your API partner, and we are committed to working with you and to help ensuring that your sampling process is effective, safe and as contamination-free as possible. Where it’s relevant, we look forward to sharing our sampling and handling procedures with you.

If you need more information about bulk product sampling processes that may be used, please contact us. 

Our recent webinar, Sustainability by Design — Implementing Safe Solutions to Reduce Risks, was all about how the Teva api sustainability team ensures safe solutions are implemented from the earliest stages of API development all the way through to the commercial stage.

Speakers included Franjo Yovich, Principal Pilot Engineer at the PLIVA site in Croatia; Gaash Bar Tal, Director of Sustainable Operations and Green Technologies in Teva’s Global Manufacturing Tech Support Group; and Moshe Turgeman, Associate Director of Process Safety at Teva api.

The webinar covered multiple topics, including:

• What sustainability in the labs actually means
• How to identify highly-hazardous materials
• Why flow chemistry is a hot new technology
• How to judge if a product is safe or needs to be ‘let go’
• What equipment is needed to discover risky situations

Franjo spoke about the safety aspects of process development. He explained how to know whether our processes are safe or not, and what information we need to provide to our colleagues in production to keep things safe.

He showcased some recent terrible disasters in the news, where factory explosions caused many casualties in Slovenia, Bosnia and Lebanon, and described the equipment Teva api uses to detect unsafe processes.

Gaash explained what process sustainability is, why we need it, and how Teva api embeds it into the product lifecycle. He explained how sustainability is a combination of the economic aspects, environmental aspects and social aspects.

With pharma, which is such a resource-intensive industry, the API part is actually the biggest contributor to the sustainability of the pharmaceutical industry. We are producing 150kg of waste per 1kg of API we are producing, 90% of the total mass of API production is coming from solvents and water, and 80% of the environmental footprint of API production is related to solvent and energy management.

So focusing on process sustainability as part of the product lifecycle management in API production is crucial.

Moshe described how Teva api implements solutions to reduce risks. The answer is three-fold: safer material selection, better wastewater treatment, and safer work processes.

He talked about the standards and guidelines that Teva developed, as well as design principles as part of the engineering process. These were distributed across all Teva sites and employees were fully trained on how to reduce risks.

At the end, the speakers answered 3 questions from listeners.

1. 
   

   Do you have a system to evaluate product sustainability?

   
   

Gaash talked about the internal tool Teva api developed called the ‘eco-efficiency tool’ to evaluate product sustainability. In the evaluation, they score different aspects of the process, like temperature, yield, volume, solvent selection. Each aspect gets a score and the entire product gets an aggregated score of up to 100. The more sustainable, the higher the score. Once you have the score, you can analyze and act upon it and know exactly where your place your efforts in the lifecycle management.

2. 
   

   Is there a system that helps to exclude an unsafe process? Are all processes in Teva api safe?

   
   

Franjo answered that emphasis should be put onto the understanding, putting all the knowledge together and deliver it to production. Teva api adopted a system from scientist, Francis Shtesel in the late 2000s in which all processes are put into a criticality class based on temperatures. The ratio of different temperatures will tell us which kind of criticality class we have. Criticality class 1 means a safe process and we can go further and criticality class 5 means unsafe and needs to be reworked. Using this approach, we can determine what is safe and what is not.

3. 
   

   Could you provide an example of implementation of inherent safety in design with a passive element?

   
   

Moshe said that once we know the criticality of a reaction, we go through designing of an emergency relief system. For this, you need data from the early stages of development, and we also use external world acceptable software. We plug in all the elements of the chemical reactor, including volume, size and quantity, and then design the proper vent sizing in case of emergency. This way, we implement our development data into our engineering.

If you’d like any more information on sustainability, reach out here or watch the full webinar below.

Our recent webinar, Nitrosamines: A Moving Target was a deep-dive into the issue of Nitrosamines impurities and how you can stay on top of the various evaluation requirements to remain compliant.

During the webinar, Diana Van Geenhoven, our head of global compliance, Lena Ben Moha-Lerman, Senior Director of Lifecycle Management within Teva api’s R&D team and Vesna Prgomet, our Director Global Regulatory Affairs, spoke to our listeners about the critical three-step approach when it comes to Nitrosamines, Risk Assessment, Confirmatory Testing and Changes for Marketing Authorization.

If you missed the live event, here are your highlights!

What changes should I look out for when it comes to Nitrosamines?

Over the past three years, there have been a lot of changes in Nitrosamines regulations. While the evaluation requirements started out with a focus on NDMA, now the guidelines contain many other Nitrosamines, too. It started out with Valsartan as the main product to be included, and now all chemical synthesized medicinal products as well as products produced by fermentation and biological syntheses have to be assessed. Acceptable Intake levels also have been changed during the last years.

Other extensions to the regulations include regarding the root causes for the presence of Nitrsosamines for example checking for cross-contamination as part of your evaluation.

In some cases, the evaluation criteria actually has become less stringent. For example, back in 2019 the FDA said that Nitrosamines in Sartans should be undetectable. However, in 2020 – the FDA updated this with new guidance and relaxed this requirement. Timelines have also been changed, especially in response to the COVID-19 pandemic. For example, the EMA relaxed the deadline for the first step in the Nitrosamines assessment from March 2020 to September 2020 and then again to March 2021.

Lastly, several publications have been issued over the past three years which explain the different ways that you can test for Nitrosamines, depending on the product you’re testing.

Risk mapping for Nitrosamines

There are three steps for Nitrosamines’ risk mapping. The first is the theoretical risk assessment. If a risk is found, you then move to confirmatory testing. If indeed Nitrosamines have been found at a higher amount than the limit, you will need to optimize or change the process before submitting this change to the relevant regulatory agencies. Let’s look at each stage in more detail.

Risk assessment

Theoretical assessment should address all root causes as defined by relevant guidelines and can be grouped in three potential sources for risk with Nitrosamines. These are the chemical process, cross-contamination and contaminated raw materials/solvents.

Nitrosamines formation is attributed to a reaction between the secondary amine and nitrite ion, therefore Nitrosamines can be formed in chemical process only if both of these are present. If one of those components is missing there will be no risk of Nitrosamines formation.

It is important to emphasize that secondary amine doesn’t have to be present as it is, it could also be sourced from primary/tertiary/quaternary amine that is used in the process. Secondary amines can be also process intermediates of the API itself. Similarly, nitrite can be used itself in the process or it could come from other sources such as hydroxylamine or nitric acid. Process water should also be assessed for the presence of nitrite ions, as they can react with amines used in the process.

Remember: Secondary amine and nitrite ion don’t have to be used in the same synthetic step. Traces of reagents might be carried over to the later steps.

Another aspect of potential risk could be contaminated starting materials and solvents, such as recycled solvents or materials that we source from a third-party. To address this risk at Teva api, we send dedicated questionnaires to all our vendors and based on their answers we conclude whether or not there is a potential risk. In case we conclude that there is a risk – API produced from this vendor is subjected to confirmatory analysis.

Confirmatory testing

Confirmatory testing is required for commercial products as well as for any new products to be launched. Different regulators have varying amounts of Nitrosamines that are considered to be acceptable. For example, under the EMA guidelines, less than 10% of the Acceptable Intake is considered to be low enough risk, while the FDA doesn’t spell out this ratio. The EMA also says that 10% of commercial batches should be tested, while the FDA does not have guidance on the number of batches to be tested.

At Teva api, we develop and validate highly sensitive analytical methods for confirmatory testing, utilizing machines such as GC-MS 3Q or LC-MS 3Q.

Our methods are developed to monitor specific Nitrosamines which according to the process in question could potentially be present in each API in line with all the current regulations and best-practices.

Submitting a change

Once the risk assessment activities have been completed, you’ll have a clear idea of what changes need to be implemented. For example, you may need to change the manufacturing process by adding an extra purification stage, adjusting a process, or adding a new step. You may also need to make changes to the premises or the equipment you use.

You’ll need to validate the specification and method you’ve developed to fix the problem, and ensure that you’ve controlled the change going forward, for example changing a supplier or codifying the new manufacturing process.

Now, it’s time to communicate the changes to the customers, MAH, authorities and to regulatory boards. At Teva api, as an API manufacturer and a CEP holder – we submit these change requests to EDQM, noting whether this is a minor or a major change in process. For example, the inclusion of mutagenic impurity in API specification is a minor revision, and so is any update in the impurity section.

Remember: In relevant case when nitrosoamines risk assessment needs to be added, even if the risk assessment only concludes that there is no risk being added – EDQM still requires this to be submitted as a minor revision (not as notification).

Facts and dates for your diary

• All relevant CEPs should be revised in order to control Nitrosamines by 26th September 2022.
• For US market, DMF amendment include relevant updates should be prepared and submitted to FDA in collaboration with MAH. FDA allows proposed process to be submitted with estimate for removal of the original process. The different synthetic processes should be identified by separate codes.
• Deadline for MAHs to submit changes to FDA is Oct 1st 2023.
• If the original process cannot be discontinued within a reasonable timeframe, the new or revised process should be submitted in a separate DMF.

At Teva api, we work together with our vendors, customers and partners to ensure that we carry out a thorough risk assessment and testing process, ensuring that we have plenty of time to communicate and submit changes before the dates provided.

If you’d like any more information on how we work to control Nitrosamines in our API manufacturing, reach out here, or watch the complete webinar below.

At Teva api, we always remember how essential our work is to the wider community, and this was never more important than this past year, when the COVID-19 pandemic hit. As Teva’s Chairman, Dr Sol J Barer said, “At Teva, it reminded us of our responsibility to patients, our employees, communities and the planet. It required us to adapt and conduct business as usual in the most unusual of times. It strengthened our resolve to elevate our words and actions in the face of social and racial injustice. And it reinforced climate change as a pressing concern that is not just environmental, but directly related to health.”

That’s why we are so happy to announce the results of the 2020 ESG report. This takes into account our environmental, social and corporate governance impact, and as a result, has put us in the top 10% of Pharma companies in terms of our Sustainalytics, the method that is used to measure and rate the relevant organizations.

Corporate Governance in Response to the Pandemic

In 2020, we continued to embed inclusion and diversity across the organization, including seeking high-quality, diverse talent at all levels of the business. 82% of employees agree that Teva promotes inclusion and diversity in its culture, which is a great thing to see. We also saw our best employee safety performance to date, which showed a 15% drop in recordable injuries.

In a global business, there is no ‘one way’ to be impacted by something like COVID-19. We are proud to say that we had zero COVID-19-related job losses, and as the pandemic evolves, we continue to put a lot of efforts into encouraging our staff to do what they need for their wellbeing and their families, including working flexibly, and taking paid vacation days when in need.

The Social Impact

The pandemic put medical care and access to pharmaceuticals under the spotlight, and the ESG report has certainly highlighted our ability to act under pressure. As Liran Nagar, our Teva api Global Supply Chain Hub leader, said, “There was no precedent for this. In my 16 years in supply chain, I’ve never encountered an emergency on such a grand, global scale.” Incredibly, the supply chain has remained “largely uninterrupted across all markets”, and we have made huge strides in speeding up and increasing production to meet the unprecedented need. We kept our labs open, our manufacturing sites running, and continued to serve almost 200 million people each day.,

Teva api has also taken an important role in identifying active ingredients related to COVID-19 treatments that can be of use to patients who are in intensive care units. Examples include inhalers to treat longer-term respiratory symptoms of COVID-19, and muscle relaxants that make it easier and safer to intubate patients. As one of the largest fully-integrated manufacturing and delivery networks in Pharma, we were integral in building what the ESG report calls “resilient supply chains.” We doubled the number of medicines we donated to patients in need in comparison to 2019, providing more than half a million dollars’ worth of critical supplies.

The Environment Belongs to Us All

Of course, despite a focused approach to handling the evolving pandemic, the environment needs our attention more than ever. Our environmental sustainability is a huge part of working towards a better, safer, cleaner world. Our goals are aggressive, looking to reduce Scope 1 and Scope 2 greenhouse gas emissions by 33% by 2030, in comparison to 2017. This year, we have reached 25% – an exciting milestone. We’ve also reduced total energy consumption by 6%, and water withdrawals by 13%, in the areas that need it the most.

As President and CEO of Teva, Kåre Schultz commented in the introduction to the 2020 Teva ESG report,
“While our approach is now more formalized, the tenets of ESG—operating responsibly and sustainably and caring for people and communities—have been ingrained in our company since our founding. As we celebrate 120 years of improving the lives of patients, we remain dedicated to advancing the health of our patients, our planet and our business.”

Discover the full report.

 

Here at Teva api, we’ve had a significant operational presence in Europe for many years. Over the last few months, as COVID-19 spread relentlessly across the world, we’ve gained a deeper understanding of just how valuable this presence is, and how we could optimize it to best support our supply network and ultimately provide better service to our customers.

Teva api in Europe

With approximately 50% of our manufacturing sites in Europe, including in Italy, Croatia, Hungary, and the Czech Republic, Teva api has always had a strong European presence.

In fact, Europe is a global hub for API production in general. Data shows that Europe remains a globally competitive producer of generic medicine and APIs, both for its own market and for export.

At Teva api, our network of 16 sites worldwide spans multiple countries and continents, and our dynamic supply chain moves throughout. This is vital in order to ensure diversification.

Keeping products flowing during COVID-19

When the pandemic hit, our diversified manufacturing presence meant we did not have to rely on one country or one site for all our production needs. In circumstances where the same product could be produced in multiple sites, we were able to supply it to customers from the one that was easiest to access at the time (where authorizations already existed). Our strong presence in Europe meant that we were able to continue an ongoing supply of products within Europe and globally while dealing with all the logistical challenges that arose. Our diverse manufacturing footprint provides a key advantage to our customers — and as a result, the end patient.

Our very experienced and well-connected logistics team managed to find creative ways to identify routes and deliver products, despite closed borders and canceled flights. Whether it was a more costly route or an unconventional route that took longer, the team made sure to get each order to the customer.
Our strong quality systems and robust regulatory affairs team were able to provide great support during this global pandemic, and work collaboratively with regulatory bodies in Europe and worldwide to facilitate continuous supply of essential medicines to patients globally.

Protecting our people and our products

From the start of the pandemic, we took precautionary measures to ensure that both our people and our products were protected. We managed to contain the impact of the virus on our levels of production and supply of products with three primary protective measures:

1. Smart working: We defined the people who were essential to keep production and operations moving, as well as the functions necessary to support those people. Only these individuals were permitted to physically go to the sites. Everyone else worked remotely. Limiting the number of people at the sites was fundamental to avoiding unnecessary interaction and greatly reducing the potential transmission of the virus. For those who worked remotely, our IT team made sure that everyone was equipped with all the right tools necessary to ensure uninterrupted work.
2. Healthy working: We had to ensure that our employees remained healthy. We introduced prescreening of anyone coming to the site so that no one came in who represented a risk. This included a questionnaire, temperature monitoring, etc. We also implemented an enhanced medical service at each site, which was especially important at the beginning, when the virus gained momentum in Italy. A healthcare professional provided information and examinations so that employees would feel a sense of confidence that they were being well cared for.
3. Safe working: We successfully secured personal protective equipment, e.g. masks, overalls, and gloves, for all employees on site, even when this was hard to come by. We also increased the frequency of sanitation in our facilities – cleaning and disinfecting more regularly, giving more access to sanitizers, and continuously running communication campaigns about social distancing and safe working practices. As safety protocols were issued by the government, we implemented each one in our facilities.

The impact on future manufacturing in Europe

COVID-19 has definitely changed the playing field. It will — and already has started to — stimulate companies and policy makers to reflect on the criteria that they are utilizing to source their products. If these expand to include ease of access, availability, and flexibility, then inevitably it will mean that certain manufacturing will remain in western countries, since it may not be sensible to rely solely on one region. To encourage production in Europe, policy makers need to put incentives in place to secure European investment in API manufacturing, thereby securing Europe’s manufacturing competitiveness globally. The European Commission is currently reflecting on a pharmaceutical strategy for the years to come and will drive policy initiatives which are crucial for the sustainability and resilience of API manufacturing – I am looking forward to seeing where that leads.

For example, it is important that policy makers strike a balance between the cost and availability of products in all markets, and understands the dynamics associated with that. For pharma companies to have access to APIs and for patients to have access to medicines, manufacturing and logistics need to be diversified and economically sustainable. I think that it is this realization, and the risk of future pandemics or significant world events, that will encourage countries to become more self-sufficient.

Where we’re going from here

The discussions about supply security have already started at Teva api. How do we optimize our network to mitigate future risks? How do we leverage the strengths we have based on the technologies and demographics of our products? Perhaps we should introduce measures that allow for additional flexibility, and award those who are complying with Europe’s access equity, resilience, and green ambitions — topics that policy makers should perhaps reflect on in cooperation with the sector.

As a manufacturing network, we want to be as efficient and cost-effective as possible, but these two factors do not automatically translate into access to essential medicines. Cost and efficiency are only a competitive advantage when coupled with a reliable and robust supply network.

As we review our network and move forward, we take strength in looking back at the past few months and what we have managed – and are still managing – to accomplish.

Onwards and upwards!

In our first article on DATA INTEGRITY we explained how Teva api implemented advanced computerized data management in our R&D departments. In this follow-up article we explain how and why Teva api manages it’s data in the manufacturing processes. Data that ensures our customers get the highest quality products each and every time.

Regulatory requirements regarding DATA INTEGRITY has become increasingly demanding and increasingly a hot topic at every stage of drug production. Teva api is at the forefront of developing and implementing technology to comply with the present regulations and those to come in the future. To do this Teva api is committed to advanced technological solutions that will provide full control of data integrity in all processes of API manufacturing. Another goal is to have fully automated, paperless solutions that bring added value to our customers.

Why data integrity is so important

High level of data integrity is essential in the production of API’s as it guarantees the quality of the drug. It ensures that all the data related to drugs manufacture is preserved, and provides the information to prove the quality of the drug is 100% reliable and that all this data is easily accessible and available.

With high level of data integrity our customers can be assured that our products contain only those materials that are declared and nothing else. Teva api can provide guaranteed proof for this because of our high level of data integrity. And after all, when we are dealing with human lives we need to take the utmost care.

Control of this data is critical in drug production, as any imperfections in the process can directly affect the quality of the drug and cause harm to patients. To this end Teva api employs a range of computerized systems in every department along the manufacturing process from the very beginning of production until distribution.

Data Integrity In Production Environments

Data from the manufacturing process, analytical examination, and other support departments is kept accurate, attributable original and accessible. With our unique approach Teva api has the ability to make every system compliant, both new and old. In the following paragraphs we explain how we gather and manage our data throughout the production process so customers can be sure that the API’s we provide suit their needs and comply with local and global regulations.

Data Integrity is Integrated Throughout Our Support Departments

Engineering department is responsible for establishing our production systems and our data integrity assures our customers that these changes have been correctly managed. The department uses specialized software for P&ID management and the system is fully compliant with CFR Part 11 and Annex 11. Every change to the system is track-able and available.

Maintenance department, use software for instrument calibration that has user management, audit trail, time reference control, and backup function and assures the use of calibrated equipment for production of active pharmaceutical ingredient.  This enables Teva api to assure our customers that we use calibrated equipment for API production.

Software for inventory of products and shipping management also complies fully with regulatory requirements. The software permits only released material to be used in production and enables tracking on expired materials etc. Our latest software innovation was to implement barcodes in the final packing of the material, where comparison of internal and external label by barcode assures 100% match and prevents any label errors. This way our customers can trust that they receive the correct material and documentation. Teva api has managed to reduce mistakes by 100%.

Streamlining our Laboratory compliance to enhance customer support

In our laboratory Teva api has around 25 different types of standalone software and the quality of the product is measured by these analytical systems. New upgrades are being constantly implemented to bring these systems to the highest level of compliance. This greatly helps us to support our customers with reliable data for their tests and ensures that our API’s are well within the required regulations.  These new features reduce paper work and give full control of the data exports from the analytical process.

Balances and titration systems that were managed manually have been dramatically upgraded by new technology. This greatly reduces the risk of errors and provides enhanced capabilities and faster testing times. All balances in Teva api are now connected to server-based software. This software collects the data from balances to the server. The software is fully compliant with the regulations and has user management, audit trail feature, backup functionality and time reference control. This means that users are managed by the software, date and time reference are managed by administration privileges and an audit trail is in place.

A virtual archive was created for retired standalone laboratory systems; it was a great solution making data accessible any time for a retention period of 10 years (according to regulation). The system was validated according to regulatory requirements. Data from old computerized systems is almost inaccessible with modern technology (for example WIN 2000 for Outlook), but our virtual archive provides the solution to these problems.

Getting your data has never been easier

Documentation management in Teva api is fully computerized, meaning that our customers can request data & documents via Teva api’s online customers platform and download or be emailed the required data for their projects with us for free. Our systems are used for managing standard operating procedures, analytical methods, master batch cards, validation protocols and reports and more controlled documents. Master batch cards have control print that audits each printout of the document, with the reason for reprinting. The data is accessible and managed by version, with audit trail is in place. All the data backed up and protected. When our customers come to audit us, or when submitting documentation to the authorities prior to a product release, our data is readily available and complete.

Our customers know exactly what they are getting

Teva api successful management of data integrity means that our customers can guarantee and can be assured that their product is 100% exact every time. Each of our departments use different computerized systems, from the beginning of the API production through to the distribution of the material. Our experience and professionalism give us the ability to implement new technologies in very short time. All Teva api computerized systems enable high compliance with data integrity in all sites. Our deep knowledge of computerized software and regulatory requirements means that Teva api is constantly improving its capabilities in data integrity.

The pharmaceutical industry is one of the most highly regulated industries on the planet. Regulations and requirements are constantly changing and evolving, and one thing is clear, the future will only bring more regulations and challenges, not less. Teva api is and intends to remain ahead of the game. In this article we will demonstrate why it is important to keep compliance in mind when developing new molecules in R&D, and how we recommend to use computerized systems to do that in order to align with the regulations and requirements from authorities such as the FDA, ISPE and PIC/S.

Teva api’s unwavering commitment to quality and customer experience has been acknowledged by one of our most valued customers. We are proud that United Laboratories (Unilab) in the Philippines has recognized Teva api as a Certified Supplier in the 2016 Total Quality Achievement Awards.

Learn why Teva api recevied this award and how we can support your projects from sourcing to commercial