Document 1133734

PREMARKET
NOTIFICATION
FITOVIT
(AN HERBAL DIETARY SUPPLEMENT)
EGN Pharma, Inc.
JBCPL
FITOVIT
TABLE OF CONTENTS
1
FITOVIT ............................................................................................................................
INGREDIENTS SOURCE ....................................................................................... 1
WITHANIA SOMNIFERA (WINTER CHERRY) ............................................... 3
EMBLICA OFFICINALIS
(AMALAKI). ........................................................... .5
ASPARAGUS RACEMOSUS (WILD ASPARAGUS) ........................................ 7
TINOSPORA CORDIFOLIA (GUDUCHI). ..................................................... .9
TRIBULUS TERRESTRIS (PUNCTURE VINE) ............................................. 11
CYPERUS SCARIOSUS (UMBRELLA ‘S EDGE) ........................................... 13
BACOPA MONNIERA (BRAHMI) ..................................................................
15
TERMINALIA CHEBULA (HIRDA) ...............................................................
17
PIPER LONGUM (INDIAN LONG PEPPER) ................................................ 19
PICRORHIZA KURROA (KUTKI) ..................................................................
21
MYRISTICA FRAGRANS (NUTMEG) ............................................................ 23
24
INDICATIONS ................................................................................................................
24
DOSAGE ..........................................................................................................................
PRE-CLINICAL
AND CLINICAL
STUDIES .............................................................25
LITERATURFi REFERENCES ....................................................................................51
65
HISTORY OF USE .........................................................................................................
PROPOSED PRODUCT LABELS ................................................................................67
FITOVIT M.. ....................................................................................................
67
FITOVIT F .......................................................................................................
68
CONTACT INFORMATION
........................................................................................69
i
FITOVIT
EGN Pharma, Irtc.
jBC.PL
FITOVIT
INGREDIENTS
SOURCE
Active
Each capsule contains dried extract of*:
English Name
Latin Names
Fitovit M
Fitovit F
Winter Cherry
Whithania somnifera
95 mg
62.5 mg UC
Emblica Myrobalan
Emblica offrcinalis
90 mg
90 mg
Wild Asparagus
Asparagus racemosus
50mg
1OOmg J/
Gulancha Tinospora
Tinospora cordifolia
14 mg
14mg
Small Caltrops
Tribulus terrestris
14.3 mg
14.3 mg
Nutgrass, Umbrella’s Edge
Cyperus scariosus
1Omg
1Omg
Thyme Leaved Gratiola
Bacopa monniera
20 mg
20 mg
Chebulic Myrobaian, Ink nut
Terminalia chebula
16mg
20mg J
Indian long Pepper
Piper longum
20 mg
16mg
Picorrhiza Kurroa
Picorrhiza (Roots)
1Omg
10 mg
Nutmeg
Myristica fragrans
2mg
Inactive
Maize Starch BP
140 mg
140 mg
6w
6mg
Magnesium Stearate
5n-45
5mg
Contents Per Capsule
491.3 mglt 5%
489.3 rng-l-5%
580 mge 5%
578 mgrt 5%
Colloidal Silicon Dioxide
Filled Capsule Weight
-
-
*These iugredients are widely used in Ayurvedic medicine practice
Ref: Indian Materia Medica
JBCPL
W ITHANIA SOMNIFERA
(Ashwagandha)
EGN Pharma, Inc.
JBCPL
FITOVIT
W ITHANIA
Family:
Solanaceae
Plant Part:
Roots
SOMNIFERA (Winter Cherry)
Macroscopic:
Roots:
Straight with no branches, 20-30 cm long, 6-12 m m diameter with a few
(2 to 3) lateral roots of slightly smaller size. Outer surface is buff to grayyellow with longitudinal wrinkles; the.center of the root is soft, solid mass
with scatteredpores.
Chemical constituents:
W ithanolides:
W ithanone, W ithaferin A, W ithanolides I, II, III, A, D, E, F, G, H,
I, J, K, L, M, WS-I, P and S, withansomidienone, withanolide C
Alkaloids:
Cuscohygrine, anahygrine, tropine, pseudotropine, anaferine,
isopellatierine, tropyltigloate. Total alkaloids content about 0.2%.
Raw Material SpecificationsiDrv Extract
Description
Odor
Brown to blackish brown dry powder
Characteristic
3
EMBLICA OFFICINALIS
(Amaiaki)
4
EGN Pharma, Inc.
JBCPL
FITOVIT
EMBLICA
OFFICINALI$S (Amalaki)
Family:
Euphorbiaceae
Plant Part:
Fresh and dried fruit
Macroscopic:
Fresh fruit:
Dried fruit:
Seeds:
Pale yellow, globose, depressedwith six distinct vertical furrows
Highly shriveled and wrinkled external convex surface
Trigonous, two each in three crustaceouscocci
Chemical constituents:
Fruit:
The richest known natural source of vitamin C
Contains gallic and ellagic acids rich in tannins that prevent and
retard the oxidation of vitamin C.
Raw Material Specifications-Dry Extract
Descri p tion
1 Dark brown to blackish brown dry powder
5
JBCPL
FZTOWT
ASPARAGUS RACEMOSUS
(Shatavari)
6
EGN Pharma, Inc.
JBCPL
FITOVIT
ASPARAGUS RACEMOSUS @ W ildAsparagus)
Family:
Liliaceae
Plant Part:
Roots
Macroscopic:
Roots:
Numerous short, fusiform succulent tuberous in clusters, white to
buff in color. External surface shows deep irregular longitudinal
furrows and minute transversewrinkles. The transversesection
shows a wide bark and central narrow wood.
Chemical constituents:
Saponins:
Steroid saponins, known as shatavarinsI-IV. Shatavarin I is the
major glycoside with 3 glucose and rharnnosemoieties attached to
sarsasapogenin,whereas shatavarin IV has 2 glucose and rhamnose
moieties with sarsasapogenin.
Others:
Apart from saponins, it contains alkaloids, proteins, starch, tannin,
mucilage and diosgenin.
Raw Material SpecificationsrDrv Extract
Description
Odor
Taste
Loss on drying
Total Microbial Count
Microbial limit
Heavy Metals
Arsenic
1Brown to dark brown jdry powder
Aromatic
Bland mucilaginous becoming bitter after sometime
Not more than 10%
Not more than 1000 &u/g
Free from salmonella and E.coli
Not more than 20 ppm
Not more than 2 ppm.
7
FITOWT
TINOSPORA CORDIFOLIA
8
i
EGN Pharma, Inc.
JBCPL
FITUVIT
TINOSPORA CORDIFOEIA
Family:
Menispermaceae
Plant Part:
Dried mature pieces of stem
(Guduchi)
Macroscopic:
Stem:
Erect, sparsely lenticellate and often producing long aerial roots.
Young stems are green, with a smooth surface; older ones have a
warty surface due to the presenceof circular lenticels
Chemical constituents:
Glucoside:
Alkaloids:
Bitter principles:
Glycoside-giloin, a non glucoside-gilenin and gilosterol
Tinosporin, tinosporic acid and tmosporol are present in leaves
Columbin, chasmanthin, palmarin
Raw Material SpecificationsrDrv Extract
FITOVIT
EGN Pharma, Inc.
JBCPL
TRIBULUS TERRESTRIS (Puncture Vine)
Family:
Zygophyllaceae
Plant Part:
Dried, ripe, fruit
Macroscopic:
Fruit:
Light brown nut, about 1 cm in diameter, covered with 2 long spines
and several short spines. Tips of spines almost meet in pairs together
forming pentagonal framework around the fruit.
Chemical constituents:
Major
Steroidal saponins-TerrestrosinsA, B, C, D and E,
desgalactotigonin, F-gitonin, desglucolanatigonin, gitonin etc
Hydrolysed product diosgenin, hecogenin and neotigogenin etc.
Minor
Alkaloids (not characterized) Common phytosterols-P-sitosterol,
stigmasterol; a cinnamic amide derivative-terrestiamide and
7- methylhydroindanone
Raw Material SpecificationsrDrv Extract
Description
Odor
Taste
Loss on drying
Total Microbial Count
Microbial limit
Heavy Metals
Arsenic
Pale brown to dark reddish brown dry powder
Characteristic
Bland mucilaginous slightly bitter afterwards
Not more than 10%
Not more than 1000 cfu/g
Free from salmonella and E.coli
Not more than 20 ppm
Not more than 2 ppm
11
FITOVIT
EGN Pharma, Inc.
JBCPL
CYPERUS SCARIOSUS (Umbrella’s Edge)
Family:
Cyperaceae
Plant Part:
Tubers
Macroscopic:
Tubers:
Deep brown in color with aromatic odor
Chemical constituents:
Essential oils:
Steam distillation of the tubers yields 0.0750.080% of oil.
Raw Material SpecificationslDrv Extract
Description
Odor
Taste
Loss on drying
Total Microbial Count
Microbial limit
Heavy Metals
Arsenic
Dark brown colored dry powder
Deep aromatic
Astringent and bitter
Not more than 10%
Not more than lOOO;cfu/g
Free from salmonella and E.coli
Not more than 20 ppm
Not more than 2 pprj~
13
FITOclT
EGN Pharmz, Iltc.
JBCPL
BACOPA MONNIERI
(Brahmi)
14
FITOVIT
EGN Pharma, Inc.
JBCPL
BACOPA MONNIERA
(Brabmi)
Family:
Scrophulariaceae
Plant Part:
Dry entire plant, preferably leaves and stems
Macroscopic:
Plant:
Leaves:
Creeping, glabrous, succulent herb, rooting at nodes. Stem lo-30 cm
long, l-2mm thick, soft, glabrous; branches ascending
0.6-2.5 cm long and 3-8 m m broad, sessile,obovate-oblong or
spatulate,entire, nerves obscure and lower surface dotted
Chemical Constituents:
Saponins:
Triterpenoid saponins, called bacosides
Others:
Alkaloids-brahmine, Sterols-betasitosterol,stigmasterol
Raw Material SuecificationsiDrv Extract
Description
Odor
Taste
Loss on drying
Total Microbial Count
Microbial limit
Heavy Metals
Arsenic
1Dark brown colored dry extract
I Aromatic
Bitter
Not more than 10%
Not more than 1000 cfu/g
Free from salmonella and E.coli
Not more than 20 ppm
Not more than 2 ppbm
15
FITOvlT
JBCPL
TERMINALIA CWER@ULA
(Hirda)
16
EGN Pharma, Inc.
JBCPL
FZTOVZT
TERMINALIA
Family:
Combretaceae
Plant Part:
Fruit
CHEBULA (Hirda)
Macroscopic:
Fruit:
Drupe, pendulous, 2-4 cm long, oblong from a broad base, glabrous,
ribbed; when dry, yellowish greqn, bark 6 m m thick, dark brown,
many generally shallow vertical cracks.
Chemical constituents:
Fruit:
Astringent substancessuch as chebulinic acid, tannic acid, gallic acid
etc. Resin and a purgative principle of the nature of anthraquinone
and sennosideare also present.
Raw Material Specification&Drv Extract
Description
Odor
Taste
Loss on drying
Total Microbial Count
Microbial limit
Heavy Metals
Arsenic
Brown to dark brotin dry powder
Characteristic
Astringent and bitter
Not more than 10%:
Not more than 1000 cfu/g
Free from salmonella and E.coli
Not more than 20 p@m
Not more than 2 pph
17
JBCPL
PIPER LONGUM
(Indian Long Pepper)
18
EGN Pharma, Inc.
JBCPL
FITOVIT
PIPER LONGUM (Indian kong Pepper)
Family:
Piperaceae
Plant Part:
Fruit
Macroscopic:
Fruits:
Solitary, pedunculated, fleshy spike 2.5 to 3.5 cm long, 5 m m thick,
ovoid, oblong, shining blackish green in color.
Chemical constituents:
Fruits:
Contain 1% volatile oil, resin, alkaloids-piperine and
piperlonguminine, a waxy alkaloid-N-isobutyldecatrans-2-trans-4dienamide and a terpenoid substance.
Raw Material Snecif‘icationslDrv Extract
1 Arsenic
Not more than 2 ppm
19
EGNPharma, Inc.
JBCPL
KUR&OA
(Kutl@
PICROHEA
3
P
20
EGN Pharmu, Inc.
JBCPL
FITOVIT
PICRORHIZA
KURRQA (KutkQ
Family:
Scrophulariaceae
Plant Part:
Dried rhizomes and roots
Macroscopic:
Rhizome:
Sub-cylindrical 2.5-6.0 cm long and 0.5-1.0 cm thick, external
surface grayish-brown, rough due to longitudinal wrinkles, tip ends
in a growing bud surrounded by tufted crown of leaves.
Roots:
Thin, cylindrical, 5-10 cm long @OS-O.
1 m m in diameter, straight or
slightly curved, mostly attached W ith rhizome, dusky gray inner
surface black with whitish xylem.
Chemical constituents:
Major:
Kutkin comprised of kutkoside and the Iridoid glycosides, picroside
I, II, III
Minor:
Apocynin, drosin and nine cucurbitacins
Raw Material Specifications+Drs Extract
Description
Odor
Taste
Loss on drying
Total Microbial Count
Microbial limit
Heavy Metals
Arsenic
Dark brown colored dry powder
Characteristic i
Very bitter
Not more than 10%
Not more than 1000 cfu/g
Free from salmonella and Ecoli
Not more than 20 ppm
Not more than 2 nnm
21
FIToV?T
MYRISTICA
FRAGRANS
22
EGN Pharma, Inc.
JBCPL
FITOVIT
MYRISTICA
Family:
Myristicaceae
Plant Part:
Seed and Arillus
FRAGRANS (Nutmeg)
Macroscopic:
Seed (Nutmeg):
Oblong, obtuse, with shiny testa
Arillus:
A thin leathery tissue between the stone and the pulp, bright red to
purple when harvested, after drying changesto amber color
Chemical constituents:
Nutmeg:
Essential oil (up to lo-15 %) mostly composed of terpinene
hydrocarbons, beta-terpinene,myristicin, elincin, and safrole.
Fixed oil (nutmeg butter), my&tine, butyrin
Mace:
Essential oil (similar to nutmeg in slightly different amounts)
Raw Material Specifications;Drv Extract
Description
Odor
Taste
Loss on drying
Total Microbial Count
Microbial limit
Heavy Metals
Arsenic
Dark brown colorqd dry extract
Aromatic Strong
Pungent and aromatic
Not more than 10%
Not more than 1000 cfu/g
Free from salmonella and E.coli
Not more than 20 Ppm
Not more than 2 ppm
23