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Your specialists in probiotic- and phyto-pharmaceuticals, biological APIs as well as contract manufacturing German Group of Companies

German Group of Companies - CPhI OnlineGerman Group of Companies. ... Ponsocol® helps calves to better resist post-calving diarrhea during the first weeks of life, ... – Colostrum

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Your specialists in probiotic- and phyto-pharmaceuticals, biological APIs

as well as contract manufacturing

German Group of Companies

Long-standing established biological research, highly Active Pharmaceutical Ingredients and GMP-certified production – for your success in global markets

Pharma-Zentrale was founded in 1953 and is located in Herdecke, a historic trading place and picturesque city in the heart of North Rhine-Westphalia, Germany.Even today the company is a family business, representing a group of subsidiaries, each one a successful specialist in its particular pharmaceutical or biotechnological businesses.Our company group comprises BBT Biotech, Ardeypharm, Dr. Poehlmann & Co. and Dr. Ponsold Pharma.The services and cooperation we offer are highly valued by our customers across the globe. We implement life-cycle management in all aspects and fields of our pharmaceutical business. Together with our partners, we will succeed in future business and regulatory challenges.

Export of bulk goods and finished products Contract manufacturing

Purification, fermentation, finished products International offering as API or own brands

Active bio-pharmaceuticals Viable bacteria and yeasts

Finished probiotic- and phyto-pharmaceutical products Strong track record in development and commercialisation of Escherichia coli strain Nissle 1917

Probiotic drugs for the gastrointestinal tract Herbal remedies

Chemically defined drugs

OTC productsDrugs and tonics of natural origin

Animal health productsVeterinary probiotic drugs

German Group of Companies

GMP-certified

Highly purified Active Pharmaceutical Ingredients of biological originBBT Biotech, located in Baesweiler, Germany, is specialised in the development, manufacturing and international sales of Active Pharmaceutical Ingredients of biological origin.Our key technologies include up to date and well-established manufacturing systems for a sophisticated range of viable bacteria and yeasts, special protein purification and separation methods (hormones, thrombolytic drugs) – all developed in-house.BBT Biotech provides EU-GMP-certified manufacturing. We are able to deal with international regulatory requirements.

Multistage production facilities in Germany: Purification, fermentation, finished productsAs a specialised manufacturer, we maintain strictly separated departments dedicated to protein purification and fermentation to prevent cross- contamination.We are inspected and audited regularly by German and international health authorities as a manufacturer of pharmaceutically active compounds.We offer several production steps combined with perfect process technology and state-of-the-art control systems.Fermentation capacities range from 8 up to 18,000 litres. We use various types of downstream processes. In addition we are able to provide a special separation filtration system and freeze-drying of APIs.Pharmaceutically active enzymes, hormones and proteins are isolated with high purity and according to applicable quality standards. State-of-the-art chromatographic and ultrafiltration equipment is handled by well-trained and experienced production staff. Our products are isolated and purified from human, animal and non-GMO biological sources.

International product range of APIs or own brandsDepending on customers’ needs, our product range offers active bio-pharma-ceuticals as APIs or finished dosage forms, e.g. Diclair® brand.All our products have to pass GMP tests according to international pharma- copoeia standards for confirmation of their identity, purity and activity.Certificates of analysis are provided accordingly. Please ask for your specific product solution. We are prepared for customised manufacturing and for new product developments.Corresponding documentation can be provided to enable you to register pharmaceuticals based on BBT’s active substances.

Fertility hormones, also in highly purified grade – HCG (Human Chorionic Gonadotrophin) – HMG (Human Menopausal Gonadotrophin) – FSH (Follicle-Stimulating Hormone;

Urofollitrophin) Thrombolytic drugs – Streptokinase – UrokinaseInhibitors – AprotininEnzymes – Hyaluronidase

Active bio-pharmaceuticals – Hormones – Thrombolytic drugs – Inhibitors – EnzymesViable bacteria and yeasts – Enterobacteria – Bifidobacteria – Lactobacilli – Saccharomyces

All the best for human healthArdeypharm, located in Herdecke, Germany, is a leading pharmaceutical specialist in development and manufacturing of probiotic drugs. Such as the clinical evidence-based drug Mutaflor®, which contains the world’s unique non-pathogenic Escherichia coli strain Nissle 1917 as API.The Ardeypharm product range is completed by a number of chemically and herbally defined drugs.

Finished probiotic drugs and phyto-pharmaceuticalsWe are convinced that mother nature provides many effective drugs for the benefit of human health. Ardeypharm produces and distributes in Germany a wide range of probiotic and herbal medicinal products. The product range, offered to physicians, pharmacists and patients, includes a number of chemically defined drugs that perfectly complement various therapeutic concepts.

Escherichia coli strain Nissle 1917Ardeypharm is the company that managed the transfer of Escherichia coli strain Nissle 1917 from cultivation to fermentation. Based on the established GMP fermentation of E. coli strain Nissle 1917, Ardeypharm developed and registered modern pharmaceutical dosage forms as a biological drug.

Established research into the health-promoting role of the intestinal microbiota Ardeypharm was one of the first companies to become aware of the impor-tance of intestinal microbiota (former intestinal flora) for human health. Since 1971, we have continued research and development of the E. coli strain Nissle 1917 for medical purposes. Both, the human microbiota as well as the development of biological drugs remain the focus of our research.Our R&D department works closely with hospitals and universities else- where around the globe.

Probiotic drugs for the gastrointestinal tract– Escherichia coli strain Nissle 1917– Saccharomyces cerevisiae HANSEN CBS 5926

(medical synonym S. boulardii)– Lactobacillus acidophilusChemically defined drugs – Mebendazole – Nystatin – TryptophanHerbal remedies – Refer to product list (see next pages)

OTC drugs and food supplements are following international pharmaceutical quality standardsDr. Poehlmann & Co., based in Herdecke, Germany, offers OTC drugs, tonics and food supplements. These products have all been developed and produced according to the quality standards required for pharmaceutical products.Products with beneficial health effects are becoming more and more important alongside curative treatments. Patients are requesting herbal remedies, e.g. our ginseng energy booster. The products of Dr. Poehlmann & Co. are well known, thanks to their high quality. Dr. Poehlmann & Co. supplies pharmacies as well as drugstores.

Drugs, tonics and food supplements of natural originThe most well-known brands from Dr. Poehlmann & Co. are Tai Ginseng®, Voltax® and Solaguttae®.They are all medicinal products or nutritional supplements, made from natural substances and thus meet the demands of an ever-growing target group. The active ingredients in the products of Dr. Poehlmann & Co. are Ginseng, Hawthorn, Thyme, Valerian and Hops, the B and E Vitamins, Phospholipids from Soy Lecithin and Pepsin.

Tried and tested for more than 40 years: Tai Ginseng®

Dr. Poehlmann & Co. is producing Tai Ginseng® for more than 40 years – it was one of the first Ginseng products and is arguably the most well known in Germany. In addition to Ginseng, Tai Ginseng® also contains vitamins of the B complex as well as Hawthorn. Hawthorn has been used for a long time in European herbal medicine. The balanced combination of high quality, pharmaceutical grade ingredients – Ginseng, Hawthorn and Vitamin-B complex – makes Tai Ginseng® a truly unique product in the market.

Unique healthcare for newborn calvesDr. Ponsold Pharma, with its headquarter in Herdecke, Germany, is a pioneer in veterinary probiotic pharmaceuticals and specialised in the prophylaxis of diarrhea in calves. The active ingredient in the product Ponsocol® is E. coli strain Nissle 1917.Ponsocol® has occasionally shown further positive health effects on animal welfare, health in livestock, in pets and certain zoo animals.

Ponsocol® drastically reduces diarrhea in newborn calves – the first probiotic veterinary drug in GermanyPonsocol® helps calves to better resist post-calving diarrhea during the first weeks of life, to fight off intestinal pathogens and to enhance productivity in cattle, to accelerate the establishment of intestinal microflora involved in the digestion of feed and last but not least to promote gut health.Ponsocol® effectively antagonises the spread of intestinal pathogens typically involved in the pathogenesis of diarrhea in calves (similar to EHEC).Thus, Ponsocol® helps to reduce the use of antibiotics and vaccinations and protects the health of the herd. Ponsocol® promotes the protection of respiratory diseases, e.g. pneumonia.The tolerability of Ponsocol® is excellent: no contraindications or adverse drug reactions are known.

Cost-benefit assessment of early protectionPonsocol® promotes faster improvement in growth performance and saves on co-medication costs.Some prophylactic aspects to be taken into account:– Colostrum quality is impacted e.g. stage of lactation, poor pre-calving vaccination programmes

or colostrum handling and cleanliness.– Calves from heifers run a greater risk of not getting enough colostrum in the first 24 hours.– Diseases affecting the milk yield of dairy cows, such as mastitis.

Best quality from selected active ingredients to the finished drug productsTo achieve this high quality, our group of companies follows international standards for all steps of the production process – standards which go considerably beyond the statutory norms.The quality level of the final product depends on the careful selection of starting materials. Standardised conditions of production and up-to-date technology ensure consistently high pharmaceutical quality.Our Technical Department, Production, Laboratory and R&D as well as our Medical and Clinical Research Departments are continuously working on further improving quality, efficacy and safety of our products.

GMP-certified manufacturing in GermanyPharma-Zentrale is continuously GMP-certified according the Directive 2003/94/EC.

Contract manufacturingWith our broad range of GMP-compliant contract manufacturing services for the biotechnology and pharmaceutical industry (APIs, dosage forms, e.g. tablets, capsules and liquids, pharmaceuticals as well as food supplements) we supply several companies all over the world.

Export bulkware and finished productsWe supply pharmaceutical bulk (liquid, semi-solid and solid forms). We offer a full service starting from the production of APIs using fermentation (according to Part II of the EU-GMP guidelines) followed by manufacturing of finished products, from mixing the APIs with excipients to encapsulation, bottling and packaging.

Brand name API General use Dosage Commercial forms

Application

HIGHLY PURIFIED FERT IL IT Y HORMONES Diclair® Hp-HCG Highly purified Human

Chorionic Gonadotrophin- Sterility due to the absence of fol-licle ripening or ovulation (female)

- Medically assisted reproduction programmes (females)

- Hypogonadotropic hypogonadism (male)

- Delayed puberty (male)- Deficient spermatogenesis (male)

1,500 I.U.; 2,000 I.U.; 5,000 I.U.; 10,000 I.U.

1, 3 ampoules

Intramuscular or subcutaneous useDiclair® Hp-HMG Highly purified Human Follicle

Stimulating Hormone + Human Luteinising Hormone (L.H.) (Human Menopausal Gonadotrophin)

- Follicle stimulation (females)- Stimulation of spermatogenesis (male)

75 I.U.; 150 I.U. 1 ampoule

Diclair® Hp-FSH Highly purified Human Follicle Stimulating Hormone

Stimulation of follicular recruitment, development and induc tion of ovulation (females)

75 I.U.; 150 I.U. 1 ampoule

FERT IL IT Y HORMONESDiclair® HCG Human Chorionic Gonadotrophin As described above 1,500 I.U.; 2,000 I.U.;

5,000 I.U.; 10,000 I.U.1, 3 ampoules

Intramuscular or subcutaneous use

Diclair® HMG Follicle Stimulating Hormone + Human Luteinising Hormone (L.H.) (Human Menopausal Gonadotrophin)

As described above 75 I.U.; 150 I.U. 1 ampoule

Diclair® FSH Human Follicle Stimulating Hormone

As described above 75 I.U.; 150 I.U. 1 ampoule

THROMBOLY TIC ADiclair® ST Streptokinase - Acute myocardial infarction

- Deep vein thrombosis- Pulmonary embolism- Acute or subacute thrombosis

750,000 I.U.; 1,500,000 I.U.

1 vial

Intramuscular or subcutaneous useDiclair® UK Urokinase - Acute arterial thrombosis

- Acute or subacute thrombosis- Acute lung embolism- Thrombotic artificial arteriovenous shunt

250,000 I.U. 500,000 I.U.

1 vial

Product list

Product API General use Dosage Appearance Application

HIGHLY PURIFIED FERT IL IT Y HORMONES / FERT IL IT Y HORMONESHp-HCG / HCG Highly purified / Human

Chorionic GonadotrophinAs described on the left

– Bulk Intramuscular or subcutaneous use

Hp-HMG / HMG Highly purified / Follicle Stimulating Hormone + Human Luteinising Hormone (L.H.) (Human Menopausal Gonadotrophin)

As described on the left

Hp-FSH / FSH Highly purified / Human Follicle Stimulating Hormone

As described on the left

THROMBOLY TIC AStreptokinase Streptokinase As described on the left

– Bulk Intramuscular or subcutaneous useUrokinase Urokinase As described on the left

INHIBITORSAprotinin Pancreatic trypsin inhibitor Prophylactic use to reduce

perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmon- ary bypass in the course of coron-ary artery bypass grafts surgery

– Bulk –

ENZ YMESHyaluronidase Absorption of injected fluids

increaser- Hypodermoclysis, obstetric anaes-thesia prevention of post-partum haemorrhage (with ergometrine)

- As an aid to local anaesthesia in ophthalmology

- As an aid to local anaesthesia in fracture reduction

- Subcutaneous administration of radiopaque substances in pyelography

– Bulk Injection/Infusion

VIABLE BAC TERIA AND YE ASTSBifidobacteria –

– –Batch sizes up to several kilograms

–Enterobacteria e.g. Escherichia coli

Lactobacilli e.g. Lactobacillus acidophilus

Saccharomyces e.g. Saccharomyces boulardii

Product list

Product/API API General use Commercial forms

Pack size Average daily

PROBIOTIC DRUGSMutaflor® E. coli strain

Nissle 1917- Ulcerative colitis in the remission stage

- Chronic constipation

Hard capsules 20, 50 and 100 caps.

2 x 1 caps. a day

Mutaflor® Suspension E. coli strain Nissle 1917

- Diarrhea in newborns, infants and children

- Diarrhea in newborns, infants and children under tube feeding

- Colonisation prophylaxis in pre-mature and full-term neonates

- Enhancement of postnatal im-mune competence in premature and full-term neonates

Suspension 5 and 25 x 1 ml5 and 25 x 5 ml

1–3 x 1 ml a day

Paidoflor® Lactobacillus acidophilus

Small bowel disturbances, e.g. in case of constipation or diarrhea

Chewable tablets 20, 50 and 100 tab. 1–3 x 3 tab. a day

Yomogi® Saccharomyces boulardii, lyophilised

Acute diarrhea (e.g. Antibiotic-associated diarrhea), Travelers’ diarrhea

Hard capsules 10, 20, 50 and 100 caps.

2 x 1 caps. a day

CHEMIC ALLY DEFINED DRUGSAdiclair® Nystatin Fungal infections

(especially Candida)Tablets 20, 50 and 100 tab. 3 x 2 tab. a day

Suspension 24 and 48 ml 3–6 x 1–2 ml a day

Ointment 20, 50 and 100 g 3 x a day

Cream 20 and 50 g 3 x a day

Vaginal tablets 12 tab. 2 x 1 tab. a day

Oral gel 25 and 50 g 4 x 1 g a day

Surfont® Mebendazole Worm infection with nematodes Tablets 6 tab. 1 x 1 tab. a day for 3 days

Ardeytropin® Tryptophan Facilitates falling asleep in insomnia

Tablets 20, 50 and 100 tab. 1 x 2 tab. a day

Mykotin® Miconazolnitrate Oral thrush Oral gel 20 and 50 g 4 x 1 measuring spoon of gel a day

Product list

Product/API API General use Commercial forms

Pack size Average daily

PHY TO-PHARMACEUTIC ALSArdeycholan® Artichoke leaf

dry extractDyspeptic disorders Hard capsules 20, 50 and 100

caps.3 x 1 caps. a day

Ardeycordal® Hawthorn leaf and flower dry extract

Reduction in heart function (NHYA stage I)

Coated tablets 20, 50 and 100 tab. 3 x 1 tab. a day

Ardeyhepan® Milk thistle fruit dry extract

Adjuvant therapy of liver diseases and to protect liver from damage

Coated tablets 20, 60 and 100 tab. 2 x 2 tab. a day

Ardeynephron® Java tea leaves dry extract

Adjuvant therapy of minor urinary complaints

Hard capsules 20 and 50 caps. 3–4 x 2 caps. a day

Ardeysedon® Valerian and Hop dry extract

Nervous restlessness Coated tablets 20, 50 and 100 tab. 3 x 2 tab. a day

Ardeysedon® Nacht Valerian and Hop dry extract

Difficulty falling asleep due to nervousness

Coated tablets 50 and 100 tab. 1 x 1 tab. a day

Doloteffin® Devil‘s claw root dry extract

Supportive therapy of degenerative illnesses of the musculoskeletal system

Tablets 10, 20, 50 and 100 tab.

3 x 2 tab. a day

Orgaplasma® Ginseng root dry extract

Feeling of weakness; lack of concentration and during convalescence

Coated tablets 20, 50 and 100 tab. 2 x 2 tab. a day

Passidon® Passionflower herb dry extract

Nervousness, restlessness Hard capsules 50 and 100 caps. 2 x 2 caps. a day

Plissamur® Horse chestnut seed dry extract

Symptoms of peripheral chronic venous insufficiency

Coated tablets 20, 50 and 100 tab. 2 x 1 tab. a day

Product list

Product API General use Commercial forms

Pack size Average daily

Cevitect® Thyme herb dry extract

Cold related respiratory illness, persistent coughing, expectoration in acute bronchitis

Pastilles 30 past. Suck 3–4 pastilles, 3–4 times daily, one after the other

Pepsin Wine Pepsin powder from the pigs

Improves stomach function Liquid 700 ml 20 ml with each meal (3 times daily)

Solaguttae® Valerian-Hop Valerian root dry extract, hops dry extract

Restlessness, anxiety and insomnia

Coated tablets 60 tab. 2 coated tablets, 1–3 x daily

Solaguttae® Valerian-Hop extra strong

Coated tablets 40 tab. 1 coated tablet, up to 3 times daily; insomnia: 1–2 coated tablets during the evening

Tai Ginseng® Ginseng root dry extract/powder, hawthorn leaf and flower dry extract, vitamins

Stimulating mind and body Liquid 500 ml 5–15 ml, 3 times daily

Biological energy provider, Activates natural protection against stress

Coated tablets 60 and 120 tab.

2 coated tablets, 3 times or 3 coated tablets twice daily

Tai Ginseng® Pastilles Ginseng root dry extract

Invigoration tonic, declining capacity for work and concentration

Pastilles 20 past. 3–4 pastilles daily to be sucked or chewed

Vitamin E 600 mg All-rac-alpha-toco-pheryl acetate

Ergotropic Capsules 40 caps. 1 capsule daily

Voltax® Soya lecithin Increase permeability of neural membranes

Capsules 40 and 120 caps.

3 capsules, 2–3 x daily

Product API General use Commercial forms

Pack size Average daily

Ponsocol® E. coli strain Nissle 1917

Prevention of diarrhea in newborn calves

Suspension 1 x 10 ampoules a 15 ml and 10 x 10 ampoules a 15 ml

1 x 15 ml a day

Product list

Dr. Poehlmann & Co. GmbH Loerfeldstraße 20, 58313 Herdecke, Germany

Phone +49 2330 977-678, Fax -697 [email protected] www.dr-poehlmann.de

Dr. Ponsold Pharma GmbH Loerfeldstraße 20, 58313 Herdecke, Germany

Phone +49 2330 977-679, Fax -697 [email protected] www.dr-ponsold-pharma.de

Pharma-Zentrale GmbH Loerfeldstraße 20, 58313 Herdecke, Germany

Phone +49 2330 977-676, Fax -697 [email protected] www.pharma-zentrale.de

Ardeypharm GmbH Loerfeldstraße 20, 58313 Herdecke, Germany

Phone +49 2330 977-677, Fax -697 [email protected] www.ardeypharm.de

BBT Biotech GmbH Arnold-Sommerfeld-Ring 28, 52499 Baesweiler, Germany

Phone +49 2401 933-100, Fax -1090 [email protected] www.bbt-biotech.de

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