From concept to product implementation

Product and service offerings:
– ready to be launched formulations
– packages
– medicinal product registration

medical devices

Ultrasound gel

variant

format

composition

1.

500 g

Purified water, bronopol, sodium benzoate, carbomer, sodium hydroxide

medical products

Available documentation for medicinal products/pharmaceutical raw materials

The active substance

character

dose

Borax (sodium tetraborate)

Solution for use in the oral cavity

200 mg/g

Acetylsalicylic acid

Gastro-resistant tablets

150 mg

Acetylsalicylic acid

tablets

300 mg

Glyceroli suppositoria

Suppositories

1g

Glyceroli suppositoria

Suppositories

2g

Bismuth subgallate

Powder

100g/100g

Sodium dihydrogen phosphate monohydrate
Disodium phosphate dodecahydrate

Rectal solution

(32,2mg + 139mg)/ml

Glycerol

Liquid for use on the skin

Undefined

Glucose

Powder for oral solution, oral powder

1 g/g

Ibuprofen

Film-coated tablets

200mg

Ketoprofen

Gel

25 mg/g

Ammonium sulphobitumate

Ointment

10 %

Camphor

Ointment

10 %

Vitamin A

Ointment

400 IU/g

Zinc
ammonium oxide
sulfobitumate
Borax
Tincture of cinquefoil rhizome

Ointment

(20 g + 2 g + 1 g + 8 g)/100 g

Camphor

Solution for the skin

10 %

Liquid paraffin

Oral fluid

100 %

Simethicone

Chewable tablets

80 mg

Camphor

Liquid for the skin

10 %

Salicylic acid

Solution for the skin

2 %

Iodine

Solution for the skin

3 %

Talc

Powder

Undefined

Hydrogen peroxide 30%

Solution for skin, mouthwash solution

3 %

supplements

FOR CALMING DOWN

format/

Variant

COMPOSITIONS

rws%*

1.

Capsule size “0” with a filling weight of 222 mg

Melissa officinalis extract DER 5:1 – 100 mg

nd

Cultivated saffron extract DER 4:1 – 15 mg

nd

Rhodiola rosea extract DER 25:1 standard. for 3% rosavins and 1% salidrosides – 4.75 mg

nd

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids

nd

2.

Capsule size “00” with a filling weight of 480 mg

Melissa officinalis extract – 300 mg

nd

Magnesium (magnesium oxide) – 60 mg

16%

Rhodiola rosea extract DER 25:1 standard. for 3% rosavins and 1% salidrosides – 4.75 mg

nd

Chamomile extract DER 10:1 – 20 mg

nd

Vitamin B6 (pyridoxine hydrochloride) – 0.7 mg

50%

Filling agents: magnesium salts of fatty acids

nd

3.

Transparent coated tablet, size 19x7mm, weight 830mg

Melissa officinalis extract DER 7:1 – 150 mg

nd

Hop cones extract DER 4:1 – 50 mg

nd

Rhodiola rosea extract DER 25:1 standard. for 3% rosavins and 1% salidrosides – 4.75 mg

nd

Lavender extract DER 7:1 – 50 mg

nd

L-tryptophan – 50 mg

nd

Vitamin C (L-ascorbic acid) – 40 mg

50%

Vitamin B6 (pyridoxine hydrochloride) – 0.7 mg

50%

Witamina B1 (chlorowodorek tiaminy)- 0,55 mg

50%

Vitamin B2 (riboflavin) – 0.7 mg

50%

Vitamin B12 (cyanocobalamin) – 1.25 mcg

50%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose, calcium phosphates

nd

see packaging options >>

MAGNESIUM + B6

format/

variant

composition

rws%*

1.

White coated tablet, size 19×9.5mm, weight 1400mg

Magnesium (citric acid magnesium salts) – 100 mg

26,67%

Vitamin B6 (pyridoxine hydrochloride) – 10 mg

714,29%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose

nd

2.

White coated tablet, size 19x7mm, weight 893mg

Magnesium (magnesium lactate) – 60 mg

16%

Vitamin B6 (pyridoxine hydrochloride) – 1.4 mg

100%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose , sorbitol

nd

3.

White coated tablet, size 19×9.5mm, weight 1370mg

Magnesium (citric acid magnesium salts) – 75 mg

20%

Potassium (potassium chloride) – 150 mg

7,5%

Vitamin E (DL-alpha tocopheryl acetate ) – 6mg

50%

Zinc (zinc oxide) – 5mg

50%

Vitamin B6 (pyridoxine hydrochloride) – 0.7 mg

50%

Vitamin B1 ( thiamine mononitrate ) – 0.65 mg

59%

Vitamin D3 (cholecalciferol) – 2.5 mcg

50%

Vitamin B12 (cyanocobalamin) – 1.25 mcg

50%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose

nd

see packaging options >>

POTASSIUM

format/

variant

composition

rws%*

1.

White coated tablet, size 19x7mm, weight 1140mg

Potassium (potassium chloride) – 300 mg

15%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose.

nd

2.

White coated tablet, size 11mm, weight 760mg

Potassium (potassium chloride) – 300 mg

15%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose.

nd

3.

Capsule “0” with a filling weight of 390 mg

Potassium (potassium chloride) – 200 mg

10%

Filling agents: magnesium salts of fatty acids

nd

see packaging options >>

POTASSIUM + MAGNESIUM

format/

variant

COMPOSITION

rws%*

1.

White coated tablet, size 19×9.5mm, weight 1380mg

Magnesium (citric acid magnesium salts) – 75 mg

20%

Potassium (potassium chloride) – 150 mg

7,5%

Calcium (calcium carbonate) – 37.5 mg

4,68%

Vitamin B6 (pyridoxine hydrochloride) – 0.7 mg

50%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose

nd

2.

White coated tablet, size 19x7mm, weight 1169mg

Potassium ( potassium gluconate and citrate) – 150 mg

7,5%

Magnesium (citric acid magnesium salts) – 30 mg

8%

Vitamin B6 (pyridoxine hydrochloride) – 0.7 mg

50%

Filling substances: microcrystalline cellulose

nd

3.

Transparent coated tablet, size 19×9.5mm, weight 1320mg

Potassium (potassium citrate) – 150 mg

7,5%

Magnesium (magnesium lactate) – 30 mg

8%

Vitamin B6 (pyridoxine hydrochloride) – 1.4 mg

100%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose

nd

see packaging options >>

IMMUNITY

format/

variant

COMPOSITION

rws%*

1.

Capsule size “00” with a filling weight of 410 mg

Oat beta glucan 70% DER 10:1 – 200 mg

nd

Vitamin C (L-ascorbic acid) – 160 mg

200%

Rutin – 20 mg

nd

Filling substances – magnesium salts of fatty acids

nd

2.

Yellow coated tablet, size 8mm, weight 250mg

Vitamin C (L-ascorbic acid) – 100 mg

125%

Rutin – 25 mg

nd

Vitamin D3 (cholecalciferol) – 25 mcg

500%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, silicon dioxide

nd

3.

Capsule size “00” with a filling weight of 1070 mg

Vitamin C (L-ascorbic acid) – 1000 mg

1250%

Filling agents: magnesium salts of fatty acids

nd

4.

Yellow coated tablet, size 19×9.5mm, weight 1720mg

Vitamin C (L-ascorbic acid) – 1000 mg

1250%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose , calcium phosphates

nd

see packaging options >>

MULTIVITAMINS

format/

variant

COMPOSITION

rws%*

1.

Pink coated tablet, size 19x7mm, weight 1150mg

Calcium (calcium carbonate) – 150 mg

18,75%

Magnesium (magnesium oxide) – 60 mg

16%

Vitamin C (L-ascorbic acid) – 80 mg

100%

Iron ( iron fumarate ) – 21 mg

150%

Horsetail extract DER 4:1-50 mg

nd

Nettle extract DER 4:1 – 25 mg

nd

Vitamin E (DL-alpha tocopheryl acetate ) – 12 mg

100%

Vitamin B3 (nicotinamide) – 16 mg

100%

Zinc (zinc oxide) – 10 mg

100%

L-methionine – 10 mg

nd

Vitamin B5 (D- calcium pantothenate ) – 6 mg

100%

Manganese (manganese sulfate) – 1.8 mg

100%

Vitamin A ( retinyl acetate ) – 800 mcg

100%

Copper (copper sulfate) – 1mg

100%

Vitamin D3 (cholecalciferol) – 5 mcg

100%

Vitamin B6 (pyridoxine hydrochloride) – 1.4 mg

100%

Vitamin B1 (thiamine hydrochloride) – 1.1 mg

100%

Vitamin B2 (riboflavin) – 1.4 mg

100%

Vitamin K1 (phylloquinone) – 25 mcg

33,33%

Vitamin B9 (folic acid) – 400 mcg

100%

Vitamin B12 (cyanocobalamin) – 2.5 mcg

100%

Chromium (chromium chloride) – 40 mcg

100%

Iodide (potassium iodide) – 100 mcg

66,66%

Selenium (sodium selenate IV) – 30 mcg

54,55%

Molybdenum (ammonium molybdate) – 50 mcg

100%

Vitamin B7 (D-biotin) – 50 mcg

100%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethylcellulose, sorbitol

nd

2.

Red coated tablet, size 19x7mm, weight 1155mg

Calcium (calcium carbonate from oyster shells) – 200 mg

25%

Calcium (calcium carbonate from oyster shells) – 200 mg

16%

Vitamin B3 (nicotinamide) – 20 mg

125%

Iron ( iron fumarate ) – 5 mg

36%

Vitamin C (L-ascorbic acid) – 15 mg

19%

Paraguayan holly extract DER 4:1 standard. for 2% caffeine – 15 mg

nd

Ginger root extract DER 4:1 – 10 mg

nd

Ginseng root extract DER 4:1 standard. for 3.6% ginsenosides – 10 mg

nd

Vitamin B5 (D- calcium pantothenate ) – 7.5 mg

125%

Zinc (zinc oxide) – 5 mg

50%

Manganese (manganese sulfate) – 1.8 mg

100%

Soy lecithin – 5 mg

nd

Vitamin A ( retinyl acetate ) – 600 mcg

75%

Vitamin D3 (cholecalciferol) – 5 mcg

100%

Vitamin B1 (thiamine hydrochloride) – 1.4 mg

127%

Vitamin B2 (riboflavin) – 1.92 mg

136%

Copper (copper sulfate) – 0.5 mg

50%

Vitamin K1 (phylloquinone) – 30 cmg

40%

Lutein – 0.5 mg

nd

Vitamin B12 ( cyancobalamin ) – 2.5 mcg

100%

Chromium (chromium chloride) – 40 mcg

100%

Vitamin B9 (folic acid) – 200 mcg

100%

Iodine (potassium iodide) – 100 mcg

67%

Molybdenum (ammonium molybdate) – 50 mcg

100%

Selenium (sodium selenate IV) – 30 mcg

55%

Vitamin B7 (D-biotin) – 63 mcg

126%

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethyl cellulose, sorbitol

nd

3.

White coated tablet, size 19×9.5mm, weight 1660mg

Zinc ( zinc gluconate ) – 5 mg

50%

Vitamin A ( retinyl acetate ) – 800 mcg

100%

Selenium (sodium selenate IV) – 30 mcg

55%

Vitamin K1 (phylloquinone) – 30 mcg

40%

Copper ( copper gluconate ) – 500 mcg

50%

Vitamin B1 (thiamine hydrochloride) – 1.65 mg

150%

Vitamin B12 ( cyancobalamin ) – 3 mcg

120%

Vitamin B2 (riboflavin) – 2.1 mg

150%

Vitamin B3 (nicotinamide) – 24 mg

150%

Vitamin B6 (pyridoxine hydrochloride) – 2.1 mg

150%

Phosphorus (calcium salts of phosphoric acid) – 125 mg

18%

Calcium (calcium salts of phosphoric acid) – 162 mg

20%

Vitamin B5 (D- calcium pantothenate ) – 10 mg

167%

Vitamin B9 (folic acid) – 300 mcg

150%

Vitamin B7 (D-biotin) – 75 mcg

150%

Vitamin C (L-ascorbic acid) – 120 mg

120%

Vitamin E (DL-alpha tocopheryl acetate ) – 18 mg

150%

Manganese (manganese sulfate) – 1.8 mg

90%

Vitamin D3 (cholecalciferol) – 5 mcg

100%

Iron ( iron fumarate II) – 3 mg

21%

Molybdenum (ammonium molybdate) – 50 mcg

100%

Magnesium (magnesium carbonate) – 100 mg

27%

Iodine (potassium iodide) – 100 mcg

67%

Chromium (chromium chloride) – 40 mcg

100%

Two-necked hawthorn extract DER 10: 1 standardized to 5% flavones – 25 mg

nd

Filling agents: microcrystalline cellulose, magnesium salts of fatty acids, cross-linked sodium carboxymethyl cellulose

nd

see packaging options >>

cosmetics

Vitamin A ointment

variant

format

INCI composition

1.

(without fragrance)

25g tube with 800 IU content palmitate retinyl in 1g of ointment

Petrolatum, Aqua, Lanolin, Retinyl Palmitate, Arachis Hypogaea Oil, Tocopherol/ 800 j.m. palmitynianu retinylu

2.

(VEGE)

25g tube with 1500 IU content palmitate retinyl in 1g of ointment

Petrolatum, Aqua, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-3 Ricinoleate, Cetearyl Alcohol, Retinyl Palmitate, Arachis Hypogaea Oil, Tocopherol

3.

(with fragrance)

25g tube with 1500 IU content palmitate retinyl in 1g of ointment

Petrolatum, Aqua, Lanolin Alcohol, Cetearyl Alcohol, Tocopheryl Acetate, Retinyl Palmitate, Arachis Hypogaea Oil, Tocopherol, Citrus Limon Peel Oil, Citral, Limonene/ 1500 j.m. palmitynianu retinylu

4.

(without fragrance)

30g tube with 1500 IU content palmitate retinyl in 1g of ointment

Petrolatum, Paraffinum Liquidum, Lanolin, Aqua, Paraffin, Cera Alba, Magnesium Stearate, Retinyl Palmitate, Arachis Hypogaea Oil, Tocopherol/ 1500 j.m. palmitynianu retinylu

Cosmetic hydrogen peroxide 3%

variant

format

composition

1.

100 ml bottle with 3% hydrogen peroxide

Aqua, Hydrogen dioxide

Hipolinum L – ointment for skin prone to intertrigo

variant

format

composition

1.

30g tube with 20% virgin linseed oil in 1g of ointment

Lanolin, Linum Usitatissimum (Linseed) Seed Oil (Olej z lnu zwyczajnego), Petrolatum

packages

material

d

h

color

purpose

bottle 120 ml

glass

54

96

pills/capsules

bottle 75 ml

glass

47

82

pills/capsules

bottle 150 ml

HDPE

53,3

93

pills/capsules

bottle 200 ml

glass

61,4

109,5

pills/capsules

bottle 120 ml

PET

50

93,5

pills/capsules

bottle 75 ml

PET

45

83

pills/capsules

bottle 150 ml

PET

50

105,5

pills/capsules

bottle 90 ml

HDPE

45,2

90

pills/capsules

bottle 60 ml

HDPE

45

67

pills/capsules

bottle 110 ml

HDPE

48

94,4

liquid

bottle 120 ml

HDPE

48

105

liquid

bottle 20 ml

glass

28

71,5

drops/vitamins

bottle 20 ml

glass

33

78,8

drops/vitamins

caps

size

material

purpose

color

38 mm

aluminium

glass bottle amber

silver

45 mm

aluminium

glass bottle amber

golden

45 mm

aluminium

glass bottle amber

silver

* – other colors on request

sachets

dimensions

solutions

filling

1

min 40×60 mm max 140×190 mm

3-side weld euro hole or notch

powder, granules, liquid*

2

min 40×60 mm max 140×190 mm

4-side weld euro hole or notch

powder, granules, liquid*

3

min 40×60 mm max 140×190 mm

3-side weld euro hole or notch

powder, granules, liquid*

* depending on product, film, formats and final machine configuration

types of pills&capsules

capsules

formats

“2”

“0”

“00”

types

gelatinous

HPMC

DRcaps
resistant to gastric acid

Plantcaps
substances sensitive to oxidation

colors

transparent

white*

red*

green*

blue*

pink*

black*

* color intensity depends on the core color

pills

formats

6

8

9.5

11

12

Oblong 19×7

Oblong 19×9,5

sheath color
(applies to film-coated tablets)

transparent

white*

red*

green*

blue*

pink*

black*

* color intensity depends on the core color

blister packing options

CAPSULES

formats	quantity per blister	blister size [mm]	number of blisters	carton size [mm]
capsule 0	10	66x89	1	70x22x94
			2	70x22x94
			3	70x38x94
			4	70x38x94
			5	70x55x94
			6	70x55x94
			7	81x22x101
			8	81x22x101
	15		1	81x38x101
			2
			3
			4
			5	81x55x101
			6
			7
			8
	20	77x128	1	81x24x133
			2	81x24x133
			3	81x51x133
			4	81x51x133
			5	81x60x133
			6	81x60x133
capsule 00	10	66x89	1	70x22x94
			2	70x38x94
			3	70x55x94
			4	70x60x94
			5	70x90x94
			6	81x22x101
			7	81x38x101
			8	81x55x101
			9	81x60x101
			10	81x90x101
	20	77x128	1	81x24x133
			2	81x24x133
			3	81x51x133
			4	81x51x133
			5	81x51x133
			6	81x51x133

PILLS

tablet size [mm]	quantity per blister	blister size [mm]	number of blisters	carton size [mm]
6 8	15	59x80	1	63x15x85
			2	63x25x85
			3	63x35x85
			4	63x45x85
			5	63x15x113
			6	63x25x113
			7	63x35x113
			8	63x45x113
			9
			10
9.5 11 12	10	40x108	1	44x20x113
			2
			3
			4
			5	44x33x113
			6
			1
			2
			3	44x47x113
			4
			5
			6
Oblong 19x7	15	66x89	1	70x22x94
			2	70x38x94
			3	70x55x94
			4	81x22x101
			5	81x38x101
			6	81x55x101
			7
			8
	15	66x89	1	70x22x94
			2	70x38x94
			3	70x55x94
			4	81x22x101
			5	81x38x101
			6	81x55x101
			7
			8
11	20	66x89	1	70x22x94
			2	70x38x94
			3	70x55x94
			4	81x22x101
			5	81x38x101
			6	81x55x101
Oblong 19x9,5	10	66x89	1	70x22x94
			2	70x38x94
			3	70x55x94
			4	70x60x94
			5	81x22x101
			6	81x38x101
			7	81x55x101
			8	81x60x101

product registration

We offer full support at the stage of registration of medicinal products

preparation of documentation in CTD format and submission of dossier to registration offices

active monitoring of the national and European registration process (DCP, MRP, changes)

full support in contacts with national registration agencies and EMA, including scientific advice

preparing responses to comments from registration agencies

coordinating registration procedures in national, mutual recognition and decentralized procedures (NR, MRC and DCP)

preparation of information forms

We offer full support as part of services in the dietary supplements and cosmetics sector

development of the Finished Product Specification (supplements) or product card (cosmetics)

support for the design process of labels, cartons, tubes, etc.

preparation of documentation necessary for the notification process, including reports from external institutions

notification (assistance in reporting to relevant offices)

in what areas we support the client

We offer our clients a full scope of product development (dietary supplement, medical device, medicinal product)
in sequence from concept to implementation, including, among others:

development of the product recipe

selection of high-quality raw materials and qualification of suppliers

conducting suppliers audits

technology development

analytical tests of the product, including stability tests (long-term, accelerated, intermediate)

process validation

full system documentation appropriate to the legal status of a given product

types of stability tests

long term

carried out throughout the shelf life declared for a given product, under the storage conditions recommended on the label

accelerated

tests designed to accelerate the chemical decomposition processes and physical changes of the product under the influence of more stringent temperature and humidity conditions; the results of these tests allow, for example, to predict the stability of the product during short-term deviations from the declared storage conditions, which may occur, for example, during transport.

indirect

conducted at a temperature of 30°C and a humidity of 65% RH, designed to moderately accelerate the chemical decomposition and physical changes of the product stored long-term at a temperature of 25°C.