Folder: Pharma

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 E F * J p O o w T T T S S R P M E D C B B B A a u a a a u f h m w t l c e u u i u h e h n a i t a b b b n n a a x n t i l s l f r i e h s d e e k c o e f b g r l l l e c i e e e e l t y p m c v i e a i h a r l i c r b n f i l l r t t t t d n c a i y a i c t s h t e i s i g u a e n i t i i e o o d b r r e l a n a n s e n h i o c n i n g s e s r i i n p n r a e g g r t e s n e u c z e m s o t t g r c a i a d l y u o o s n r a a a f u a e i a l m g u t e f n t g i u g e o r i f p n e t c c e n r c o e t e e a e i f t g r s e a n e c e m r o n r s n n p u m u r l o t ’ t s s k t l a t i r l i u t o r n e e i a i n t n o c l p n d c s s g t s d g a f r a i a u c e o o l i l J l r s r a i n u n d p r t i t p u i i g t e s r u e e r y t n o e , n s c r i o n d g t s a t o s n t y u n b f r c d s u d u t t u h n r p s p u p e z s l g c a p , l e a o y s o s x u v r u a a c t e e n s n i r t p r p d h i s A i m e e e o P n n e p l v s I t i x f o s s e i e c o r r a t a - i n s a p t s n s c h n i d i w e e t e - n r n m e c o t c l o l l s i e n e a u e a s i n e n r n t f a e f e t d o l h x r s r c e m t p a s i p r c l t o i i o o s n e d f m e n a u t t r r p h c s a e e o t l s o s s . f i t a i o l t n s a Q d w ■ ■■■ ■■■ ■ n o 3 i d d c D Citric Acid Anhydrous e u o , s ■ m t p s h e t r Trisodium Citrate Anhydrous e a e n ■ r t a t e s s d .

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