Pharma

Active Pharmaceutical Ingredients and Excipients Pharma Jungbunzlauer's comprehensive solutions

Jungbunzlauer serves a broad range of industries with its natural and sustainable ingredients, including the pharmaceutical industry. Committed to our rigorous quality standards, our active pharmaceutical ingredients and excipient portfolio meet the highest quality standards. Jungbunzlauer's products can be used in various applications and provide a comprehensive solution for the entire pharmaceutical industry.

Highest quality standards The quality of our products has a profound impact on the quality of our customers' end products. This applies not only to our products, but also to packaging, documents and logistics. At Jungbunzlauer, we use state-of-the-art technologies and continuously improve our processes in order to manufacture cost effective and safe products of exceptional quality.

Jungbunzlauer’s internal quality standards are more stringent than international norms and we continuously invest in research and development to sustain these high standards. Overall, our products meet the requirements of relevant international food and drug regulations as well as other essential regulations.

With a combination of top product quality, specialised technical service and experienced regulatory affairs, always in time and close to the customer, Jungbunzlauer is able to offer individualised customer solutions.

Pharma development at Jungbunzlauer Jungbunzlauer began producing active pharmaceutical ingredients in 2000. Since then our portfolio has grown continuously. Our goal is to provide additional regulatory documents like a Type II US drug master file (DMF) and/or certificate of suitability to the monographs of the European Pharmacopeia (CEP) to support and facilitate worldwide drug licensing of our customers.

CAA US DMF TMC CEP TSC US DMF

2000 2012 2017 2020 Year 2009 2016 2018

TPC US DMF TPC CEP CAA CEP TSC CEP Active Pharmaceutical Ingredients

Jungbunzlauer’s manufacturing site in Ladenburg, Germany, is manufacturing plant in Germany has been confirmed compliant with specialised in the manufacture of active pharmaceutical ingredients cGMP regulations set out in the FDA and EU GMP Guide since 2001. (APIs). This site is registered with the responsible German authorities (§67 German Drug Law) as an API manufacturer. According to Our current API portfolio covers four different products, which can ICHQ7 we have acquired and maintained Good Manufacturing be provided with a DMF and/or CEP to facilitate finished drug Practice (GMP) certificates from the legal authority (Regierungsprä- registrations in USA, Europe and beyond. sidium Tübingen) for our range of APIs. Jungbunzlauer's API

API Registration status Applications Citric Acid Anhydrous US DMF, USP Bowel and colon cleansing (with Magnesium Oxide) CEP, Ph. Eur. Antacid (with Sodium Bicarbonate) GMP certificate Citrate source Acidifying agent Blood treatment Tripotassium Citrate Monohydrate US DMF, USP Renal tubular acidosis CEP, Ph. Eur. Kidney-stone management GMP certificate Electrolyte replenishment Potassium deficiency (Hypocalemia) Cystitis Systemic alkaliser Trimagnesium Citrate Anhydrous CEP, Ph. Eur. Constipation GMP certificate Magnesium deficiency Muscle function normalisation Laxative Magnesium supplement Trisodium Citrate Dihydrate US DMF, USP Rehydration solution CEP, Ph. Eur. Electrolyte replenishment GMP certificate Laxative Anticoagulant Acidifier

Jungbunzlauer regularly expands the API portfolio according to customer and market needs. Please get in touch with us to acquire further information or to receive a personal quote for one of our APIs. API portfolio at a glance

Citric Acid Anhydrous Jungbunzlauer offers citric acid anhydrous (CAA) for pharmaceutical use holding a CEP, a Type II US DMF and a GMP certificate. This unique quality standard helps us to provide optimal product solutions for the pharmaceutical industry. Citric acid is used in a variety of applications, mostly as excipient, acting as acidulant, pH regulator or effervescent aid in applications like tablets, dry blends, emulsions and suspensions. In addition, citric acid anhydrous is widely used as API in finished drug formulations. It is applied in combination with sodium bicarbonate as antacid to treat heartburn or stomach upset. CAA is reacting with magnesium oxide to magnesium citrate which acts as laxative and is taken prior to colonoscopy.

Tripotassium Citrate Monohydrate Jungbunzlauer is the worldwide leading supplier of tripotassium citrate monohydrate (TPC) as an API with GMP quality and documentation, including Type II US DMF and CEP. TPC serves as potassium source in a widespread range of nutritional and pharmaceutical applications. As an API, TPC is mainly used as urinary and systemic alkaliser to treat renal tubular acidosis (RTA, TMC helps to maintain bones and teeth, normalises muscle function, Butler-Albright-Lightwood-Syndrome). In addition, TPC prevents influences the nervous system, and reduces fatigue. TMC is often crystallisation of urates due to its citrate-based chelating properties used as laxative taken prior to a colonoscopy and in supplements to and is used during kidney stone management therapy. Citrates react treat magnesium deficiency to normalise physiological body with stone forming cations to a soluble form and are subsequently functions. excreted by the body. TPC is as well used as an API for electrolyte replenishment therapies in hypokalemia and its alkalizing properties Trisodium Citrate Dihydrate can be used to treat the symptoms of cystitis. Jungbunzlauer provides trisodium citrate dihydrate (TSC) with a GMP certificate, Type II US DMF and a CEP for drug product Trimagnesium Citrate Anhydrous registrations. Trimagnesium citrate anhydrous (TMC) has a GMP certificate and TSC, mostly used in its dihydrate form, has excellent pH regulation a CEP. Jungbunzlauer is prepared to expand its regulatory documents and buffering properties. As an API, TSC is widely used in oral according to the customer needs. rehydration solutions, laxatives or alkalising products.

To facilitate your licensing activities, Jungbunzlauer strives for high-quality regulatory support and provides four APIs with an US Type II DMF and/or CEP.

API US DMF CEP Citric Acid Anhydrous #23078 R0-CEP 2016-005-Rev 02 Trimagnesium Citrate Anhydrous - R0-CEP 2015-129-Rev 01 Tripotassium Citrate Monohydrate #14847 R1-CEP 2011-388-Rev 01 Trisodium Citrate Dihydrate #32842 R0-CEP 2018-273-Rev 00 Excipients

Jungbunzlauer’s products support the life science efforts of the widespread. We support our customers by providing required pharmaceutical industry and play an important role in the composition documents and data like elemental impurities according to ICH of a variety of prescription drugs and over-the-counter products. Q3D, statements on residual solvents, BSE/TSE, GMO, allergens Our pharmaceutical products cover APIs as well as excipients of and others. which the functionalities of the excipients and mineral salts are

Functionalities of Jungbunzlauers excipients and mineral salts s e u e t t o a a r r n d d e o y y n s c h e e h t o u t i e u n e l t t a a o t A D c e r r a n G

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*anhydrous form Quality standards for the safety of your products

The quality of our ingredients has a profound impact on the quality of your end product. Consistent high quality and purity of our products minimise the risk of deficiencies in your finished drug product and minimise the risk of product liabilities as well as of brand and image damages. Jungbunzlauer guarantees to fulfil required product and quality standards for the pharmaceutical industry.

GMP IPEC Jungbunzlauer’s APIs are produced at our production site in The International Pharmaceutical Excipients Council Europe (IPEC) Ladenburg, Germany, which is registered with German authorities as guarantees an appropriate quality of our excipients to improve an API manufacturer (§67 German Drug Law). This manufacturing patient safety. IPEC standards for excipients are followed in our site is compliant with current GMP as set out in the guidelines by plants in Pernhofen, Austria, and Ladenburg, Germany. the FDA and EU GMP Guide Part II. GMP certificates are available for all four APIs. ISO9001 Fulfilment of the requirements of the ISO9001 Quality Management GDP Standards is the logical result of Jungbunzlauer’s comprehensive According to EU guidelines, it is obligatory to transport medicinal quality commitment and all company's plants have been certified products and APIs according to Good Distribution Practice (GDP) according to the ISO 9001 criteria. Furthermore, all Jungbunzlauer within the European Economic Area (EEA). EU GDP guidelines production sites have completed their Food Safety System ensure high transport quality standards and integrity of medicinal Certification (FSSC) 22000. In this context HACCP – Risk assess - products and APIs and GDP guidelines are followed for all APIs ment concepts are established in our plants in Pernhofen, Austria as an integral part of our GMP system in the production plant in and Ladenburg, Germany. Ladenburg, Germany. Pharma Customer Service

Along with our APIs we can provide a documentation and service package for your specific regulatory needs, including a Letter of Authorisation for our US Type II DMFs or our CEPs, stability data or other documents required for the licensing of your finished product. Our regulatory affairs and technical service experts will support you when qualifying our APIs for production, during the preparation of your filing and in the course of the licensing procedure. This includes the option to perform on site audits at our Ladenburg plant.

Regulatory Support Audits Our experts in Regulatory Affairs are experienced in applying for Customer audits or third-party-audits can be arranged upon and maintaining API registrations at the EDQM and the US-FDA request. Our business partners can easily verify the high standards and are currently expanding the API registrations outside Europe adherent to in our manufacturing processes and in our quality and the USA. In addition, we can offer regulatory support during standards. the preparation of the respective API section in the finished drug dossier and during the licensing procedure in countries within or Application Technology outside Europe and the USA. The application technology center (AppliTech) in Ladenburg, Germany, provides professional service and experienced-based Technical Service consulting regarding the application of Jungbunzlauer products With their expert knowledge, Jungbunzlauer’s Technical Service to customers. teams support our customers in resolving their commercial and technical challenges with solutions tailor-made to their individual API Sales requirements and with up-to-date technical information on our Jungbunzlauer provides an international sales structure to cover products. The Technical Service team guarantees reliable and com - global needs for all products. A sales team with focus on pharma - petent handling of any quality-related inquiries of our customers, ceutical ingredients is established at Jungbunzlauer to enable a fast, as well as detailed information on the high quality standards in reliable and professional support of our pharma customers with the production sites and of our products. national or international drug registrations. p 4 J f J H T J C b J v b l J i N a n e h r a u u u u 0 i e o c t e o r H e o r e n n n n d m v 0

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