GenRx Pharmaceuticals Pvt. Ltd.

GenRx Pharmaceuticals Pvt. Ltd.
PHARMACEUTICAL FORMULATION MANUFACTURING UNIT
A Brief Summary
A company in the name and style of M/s GenRx Pharmaceuticals Pvt. Ltd. has been
incorporated and registered in year 2009 in Mumbai. The company’s Registered Office is
at LG1, Hill Palace, Raunak Park, Konkanipada, Pokharan Road No. 2, Thane – 400 610
Maharashtra, India.
GenRx Pharmaceuticals Pvt. Ltd has purchased the asset from M/s. Liva Healthcare
Ltd which is a winner of IDMA’s QUALITY EXCELLENCE AWARDS, and FIRST PRIZE from
District Industries Corporation for good manufacturing practices. This unit is WHO GMP
Certified.
GenRx is promoted by Mr. Rameshchandra Shankarbhai Patel. This unit is located at
A-52, MIDC, Sinnar, Dist. Nashik, about 180 Kms from Mumbai and 20 Kms from Nashik
city.
M/s. Liva Healthcare Ltd. was an associate company of the world wide famous Zydus
Cadilla group. The building is RCC structure with ground plus two floors. Total
constructed area is 2800 Sq.mtrs on a plot of 7200 Sq.mtrs with lush green
surroundings.
GenRx premise is having MIDC roads on west and south sides and vacant plot on
remaining sides and non-polluting other units around the factory. The climate is very
pleasant, cool and less humid, with plenty of trees in the vicinity.
GenRx Pharmaceuticals Pvt. Ltd is equipped with facility to manufacture the following
allopathic pharmaceuticals formulations, Nutraceuticals and natural products to national
and international standards.
The Facility has manufacturing licences namely Form No 25, 28, 32.
GenRx Pharmaceuticals Pvt. Ltd has fully functional capabilities to manufacture
Allopathic formulations, Nutraceuticals and Natural products in the form of solid and
semi-solid dosages such as Tablets, Capsules (hard gelatin); External preparations and
Cosmetic preparations. We also cater to Nasal preparations like sprays and drops to
national and international standards. The total capacity of various departments to
manufacture for major formulations in a day, for Tablets is 3.5 million Tabs
(2400Kg bulk capacity), for Encapsulation it is 1.6 million Caps. Blister Packing
Capacity is 0.75 Million Blisters and Strip Packing capacity is 0.15 Million Strips.
For External preparation the filling capacity is 100,000 aluminium tubes
(1200Kg bulk capacity) and for Cosmetics it is 70,000 lamitubes, whereas the
Nasal preparation is 50,000 units. The storage capacity for Raw Materials (RM),
Packaging Materials (PM) and Finished Goods (FG) is adequate to cater the
needs of production.
The company is reconditioned and upgraded to comply with requirements of ScheduleM,
cGMP and WHO standards as defined by the Government.
The company has an F&D laboratory of 4000 sq.ft area at their registered office premises
at Thane for the development of new products and technical support to the company.
Our clients include the following reputed companies such as;
1.
Merck India Ltd., Mumbai.
2.
Ajanta Pharma Ltd., Mumbai.
3.
Vitabiotics, UK. (Meyer Organics Ltd., Mumbai.)
4.
Puneet Laboratories. Mumbai.
Prospective clients of the companies are as follows.
1.
Zydus Cadilla health care Ltd., Ahmedabad.
2.
Bayer Healthcare P. Ltd., Thane.
The products would be manufactured and packed in blister packing – 10 Numbers to each
strip for Capsules and Tablets and 1 per carton for ointment.
The weight of Capsules inclusive of the packaging varies from 100 mg to 1.5 grams. The
average weight has been considered at 500 mg. 10 numbers of capsules are packed in 1
strip.
Tablets weigh between 150 and 1500 milligrams. The average weight has been assumed
as 600 mg. 10 numbers are packed per strip.
Ointments are packed individually in tubes. Tube content weight varies between 15 and
100 grams. The average weight of content in a tube is assumed at 15 grams or 15000
milligrams. The production facility as below;
1)
Ground Floor:
a) Two Granulation areas.
b) Four Compression areas.
c) Two Conventional Coating areas.
d) Two Autocoater areas.
d) One Drying area.
e) Five packing Lines.
f) Three Ancillary areas.
2)
First Floor:
a) Two Ointment Manufacturing areas.
b) One Cosmetic area.
c) One Nasal Preparation area.
d) Six filling Lines.
e) Six Packing Lines.
f) Two Ancillary areas.
g) Primary Packaging Stores.
3)
Second Floor:
a) One Capsule Manufacturing area.
b) Two Capsule Filling areas.
c) One Ancillary area.
d) Two dispensing Booths.
e) One Sampling Booth.
f) Thermo labile Area.
g) QA and QC Departments.
h) Thermo stable Raw Material Stores.
Utilities
GenRx has provided high quality infrastructure in terms of utilities. All the utilities are
among the best available and compliant to national and international regulatory
requirements.
QUALITY CONTROL: Department monitors all systems like environment, Water,
materials, Product-in process and finished products. The Instrumentation Laboratory is
equipped with sophisticated instruments.
MICROBIOLOGY: The Microbiological laboratory has all requisite testing facilities.
Safety features and communication
Safety systems including Fire Extinguishers, Fire blankets, first aid box, Emergency exits,
Personnel Protective Equipment’s and Safety representative takes care of fire drills,
awareness programs and other safety related activities. We also follow proper Hygiene as
per cGMP Standards.
All the operating points in the facility are provided with intercom and the computers are
equipped with ERP Software and are connected through (LAN) local area network and
(WAN) Wide area network.
Quality Assurance
The Quality Assurance team functions alongside the Management and works with clear
policies and procedures for recruitment, schedules for medical examination, training
programs, internal audits and all other requirements of GMP.
Validation
plans
for
equipment’s;
process
and
cleaning
are
written
down
and
implemented. Calibration Schedules are drawn for all equipment’s and monitored for
effective implementation.
Policies for safety and control of occupational hazards are made and implemented
strictly. An In Process – Quality Control team functioning under the Q.A. continuously
monitors all the process activities.
The Q.A. Department ensures that all the recommendations of national and international
regulations and guidelines are implemented and effectively practiced as per the
requirements of the Customers and as per the regulatory norms that are being followed.
Finished products are released into market only after approval from Q.A. Department.
GenRx LIST OF APPROVED PRODUCTS UNDER BRAND NAME
Sr.
No.
Generic Name
Product Name
Composition
Each film coated tablet contains:
1
FLOXORIN
TABLETS
Ofloxacin & ornidazole tablets
Ofloxacin IP
200 mg
Ornidazole IP
500 mg
Colour- Sunset Yellow, Titanium dioxide.
Each uncoated tablet contains:
2
KOLDCURE
TABLETS
Paracetamol, Caffeine ,
Paracetamol IP
325 mg
Phenylepherine Hcl,
Caffeine
30 mg
Chloropheniramine Maleate
Phenylepherine Hcl
10 mg
tablets.
Chloropheniramine Maleate
2 mg
Colour Tartrazine
3
BAZOOKA GEL
Salicylic acid & Lactic acid gel
4
GENRISH HAND
SANITISER
----
Salicylic acid IP
14.0 % w/w
Lactic acid IP
6.0 % w/w
Absolute alcohol IP
62% v/v
Colour Brillient Blue
Each EHG capsule contains:
5
TRAMAGEN 100
CAPSULES
Tramadol capsules IP 100 mg
Tramadol HCL IP
100 mg
EHG capsules contain permitted colours.
Each film coated tablet contains
6
7
8
9
L-CETRIGENX
TABLETS
Levo-cetrizine HCL Tablets IP
PRYLOGEN
5 mg
Colour Titanium Dioxide IP
NOSE FREE –PD Nasal saline solution 0.65%
NASAL DROP/
w/v
SPRAY
NOSE FREE- 2
%
NASAL DROP/
SPRAY
Levo-cetrizine Hydrochloride IP
Nasal saline solution
2% w/v
Lidocaine and Prilocaine
Cream USP.
Sodium Chloride IP
0.65 % w/v
Benzalkonium Chloride IP
0.01% w/v
(As Benzalkonium Chloride soln.IP)
Sodium Chloride IP
2.0 % w/v
Benzalkonium Chloride IP
0.01% w/v
(As Benzalkonium Chloride soln.IP)
Lidocaine USP 25 mg
Prilocaine USP 25 mg
In water-Miscible base.
Sr.
No.
Product Name
10
OLINIX GEL
Generic Name
Diclofenac sodium+Oleum
Lini+Methyl
Salicylate+Menthol Gel
11
12
Composition
Diclofenac sodium
1.0 %w/w
(as Diclofenac Diethylamine BP 1.16%w/w)
Oleum Lini BP
3.0 % w/w
Methyl Salicylate IP
10.0 % w/w
Menthol IP
5.0 % w/w
NOSE FREE—
OX
NASAL DROP/
SPRAY
Oxymetazoline HCl nasal
Oxymetazoline HCl USP
0.05 %w/v
solution USP
Benzalkonium Chloride IP
0.01% w/v
NO FEEL
OINTMENT
Lignocaine Ointment BP 2%
(As Benzalkonium Chloride solution IP)
w/w
Lignocaine Hydrochloride BP equivalent to
Lignocaine
2.0% w/w
Water miscible hydrophilic base
13
GMS FLEXI
TABLETS
Glucosamine Tablets USP
q.s.
Each film coated tablet contains
Glucosamine
500 mg
(as Glucosamine sulfate Potassium Chloride
USP)
Colour Tartrazine
14
15
16
GENRISH
MOSQUITO
REPELLENT
SPRAY
Diethyl Toluamide 15 % w/v
MOSJET
MOSQUITO
REPELLENT
SPRAY
Diethyl Toluamide 15 % w/v
NJOYGRA 50
Sildenafil Tablet IP 50 mg
spray
spray
Diethyl Toluamide IP
15 % w/v
Ethyl Alcohol IP
78 % v/v
Diethyl Toluamide IP
15 % w/v
Ethyl Alcohol IP
78 % v/v
Each film coated tablet contains:
Sildenafil Citrate IP equivalent to Sildenafil 50
mg
Colour Brilliant blue & Indigo Carmine
17
NJOYGRA 100
Sildenafil Tablets IP 100 mg
Each film coated tablet contains:
Sildenafil Citrate IP equivalent to Sildenafil
100 mg
Colour Brilliant blue & Indigo Carmine
Sr.
No.
Product Name
Generic Name
Composition
Each Hard Gelatin capsule contains:
Vitamin A Acetate IP…………….....2000 IU
Vitamin-E Acetate IP…………………5 IU
Ascorbic acid IP(coated)…………….25 mg
Thiamine Mononitrate IP……………1 mg
Vitamin. D3 IP……………………….100 IU
Pyridoxine HCl IP……………………1 mg
Vitamin B12 IP……………………….1 mcg
Niacinamide IP……………………….15 mg
MINVITA
1
CAPSULE (for
prophylactic use )
----
Folic Acid IP………………………….0.3 mg
Calcium Panthothenate IP…………..2.5 mg
Ferrous Fumarate IP Equi. to elemental
Iron……….…………………………..15 mg
Selenium Dioxide USP Equi. to Elemental
Selenium……………………………37 mcg
Copper Sulphate IP Equi. to Elemental
Copper………………………………0.1 mg
Manganese Sulphate IP Equi. to Elemental
Manganese……………………………1 mg
Magnesium Sulphate IP Equi. to elemental
Magnesium……………………………2 mg
Zinc Sulphate Monohydrate USP Equi. to
Elemental Zinc……………………….15 mg
EHG calsules contain Permitted colours.
Each Hard Gelatin capsule contains:
Vitamin A (As Acetate)………………...5000 IU
Vitamin D3………………………………..400 IU
Vitamin C(coated)…………………........75 mg
Vitamin E (As acetate)………………….25 mg
Vitamin B1………………………………..10 mg
Vitamin B2………………………………..10 mg
Vitamin.B6...............................................3 mg
Vitamin B12……………………………......5 mg
Niacinamide……………………………….50 mg
Folic Acid………………………………1000 mcg
Calcium Panthothenate…………………...6 mg
Copper Sulphate Equi. to elemental
Copper……………………………………0.5mg
Potassium Iodide…………………………1 mg
Zinc Sulphate Monohydrate USP Equi. to
2
VITALLECT
(Antioxidant,
elemental Zinc……………………………..11 mg
Multivitamin & Multi
Magnesium Oxide Equi. to elemental
minerals capsules)
Magnesium………………………………....2 mg
Manganese Sulphate IP Equi. to elemental
Manganese………………………………….1mg
Selenium Dioxide Monohydrate Equi. To
elemental Selenium……………………..52 mcg
Chromium Picolinate Equi. to elemental
Chromium………………………………..25 mcg
Lycopene 10%.................................2000 mcg
Lactic Acid Bacillus……………….2.5 lit spores
Approved colours used in empty capsule shells.
Each Hard Gelatin Capsule Contains
Lycopene 10%....................................2000 mcg
Vitamin A Acetate IP…………………..2000 IU
Viatmin E Acetate IP……………………5 IU
Ascorbic Acid IP (coated)………………40 mg
Zinc Sulphate Monohydrate USP Equi. to
VITAPENE
3
elemental Zinc……………………….5 mg
CAPSULES (for
Copper Sulphate Equi. to elemental
prophylactic use)
Copper…………………………………….0.5 mg
Manganese Sulphate IP Equi. to elemental
Manganese……………0.6 mg
Selenium Dioxide USP Equi. to elemental
Selenium…………………26 mcg
EHG capsules contain permitted colours.
Each film coated tablet contains
Viatmin B1 Mononitrate IP………………..2 mg
Vitamin B2 IP………………………………3 mg
Niacinamide IP…………………………….20 mg
B-GEN Tablets (for
4
prophylactic use)
Viatmin B6 IP……………………………….1 mg
-------
Calcium Pantothenate IP…………………..4 mg
Methylcobalamine IP…………………….0.5 mcg
Vitamin C IP………………………………50 mg
Folic Acid IP………………………………0.3 mg
Biotin USP………………………………300 mcg
Color: Ponceu 4R
Each uncoated flavoured chewable tablet
contains:
Vitamin A (as acetate) IP………………..1600 IU
MVITAGEN (for
5
prophylactic use)
Viatmin D IP/BP………………………….100 IU
Thiamine Mononitrate IP…………………1.0 mg
Riboflavin IP/BP…………………………..1.0 mg
Pyridoxine HCl IP…………………………1.0 mg
Niacinmide IP……………………………..15 mg
Vitamin C IP ……………………………….25 mg
GenRx LIST OF PRODUCTS COMING UNDER SCHEDULE C & C1 (Generic)
Sr.
No.
Product Name
Generic Name
Composition
Each capsule contains:
1
----
Omeprazole Capsules IP 20mg
Omeprazole IP(as enteric coated
granules)
2
----
3
----
Piroxicam Capsules IP 20 mg
Tramadol HCL Capsules BP
100 mg
Each capsule contains:
Piroxicam IP
----
Triamterene Capsules IP
5
----
Ceterizine HCL tablets IP 10mg
6
----
7
----
Famotidine tablet USP 20 mg
8
----
Fluconazole tablet
20 mg
Each capsule contains:
Tramadol HCL BP
4
20 mg
100 mg
Each capsule contains:
Triamterene IP
50 mg
Each film coated tablet contains:
Cetirizine Hydrochloride IP
10 mg
Diclofenac Potassium tablet
Each film coated tablet contains:
USP 50 mg
Diclofenac Potassium USP
150 mg
50 mg
Each film coated tablet contains:
Famotidine USP
20 mg
Each uncoated tablet contains:
Fluconazole USP
150 mg
Each uncoated tablet contains:
9
----
Paracetamol tablet IP 500 mg
Paracetamol IP
10
----
Pseudoephedrine HCL IP
Each film coated tablet contains:
Pseudoephedrine HCL IP
500 mg
30 mg
Sr.
No.
Product Name
Generic Name
Composition
Diclofenac diethylamine BP 1.16 % w/w
11
Diclofenac Gel BP
----
(equivalent to Diclofenac Sodium 1.0%
w/w)
Diclofenec Diethylamine BP 1.16 % w/w
(equivalent to Diclofenac Sodium 1.0 %
12
13
----
Diclofenec Diethylamine +
w/w
Oleum Lini + Methyl Salicylate
Oleum Lini
+ Menthol Gel
(containing
Miconazole Nitrate cream IP
----
Silver Sulphadiazine &
14
Chlorhexidine Gluconate
----
Cream
3.0 % w/w
linolenic acid)
M hyl Salicylate IP
10.0%w/w
Menthol IP
5.0% w/w
Miconazole Nitrate IP
Silver Sulphadiazine USP
2.0% w/w
1.0 % w/w
Chlorhexidine Gluconate solution 20 % IP
equivalent to Chlorhexidine Gluconate
0.20 %w/w.
Oxymetazoline Hydrochloride USP
Oxymetazoline Hydrochloride
15
----
Nasal Drops USP
0.05% w/v
Benzalkonium Chloride soln IP
(equivalent to Benzalkonium Chloride)
0.01 % w/v
GenRx LIST OF APPROVED PRODUCTS UNDER ( COSMETIC )
Sr.
No.
Product Name
Generic
Name
Composition
Oxybenzone USP…………………………. 3.0 % w/w
1
SUN SCREEN LOTION
-----
Octyl Methoxycinnamate …………… 7.0 % w/w
Vitamin–E AcetateIP…………………… 0.2 %w/w
Niacinamide ……………………………….1.0%w/w
2
GENRISH BEAUTY
CREAM
Octyl Methoxycinnamate………
-----
…1.25%w/w
Dimethicone 100 cst……………………..2.0%w/w
Liquorice Extract ……………………………2.0%w/w
Oxybenzone…………………………………..3.0%w/w
3
GENRISH SUN SCREEN
LOTION
Octyl Methoxycinnamate…………… ……..5.0%w/w
-----
Methylen Bis Benzotriazolyl Tetramethyl
Butylphenol……………………………………9.0%w/w
Phenoxy Isopropanol……………………
.2.0%w/v
4
GENRISH FACE WASH
------
5
GENRISH BABY OIL
------
Cyclomethicon………………………………5.0%w/v
6
GENRISH
MOISTUIRISING CREAM
------
Vitamin–E AcetateIP………………….…....0.5%w/w
7
GENRISH BABY LOTION
------
Alpha Tocopheryl acetate …………………0.2 % w/v
Dimethicone 100cst……………………...3.77%w/v
Alpha Tocopheryl Acetate………………1.0%w/v
Aloe Vera Juice……………………………....90.0%w/v
8
GENRISH HAIR GEL
------
Benzophenone 4…………………………….0.05%w/v
Imidurea……………………………………….0.10%w/v
A bird eye view of GenRx Pharmaceuticals Pvt Ltd manufacturing unit
Spacious Lobbies for easy movements
Large RM storage spaces
BSR with large storage capacity.
R.O. Water Plant having 1000Ltrs. capacity per hour.
Distilled Water Plant
A}
TABLET SECTION .
GRANULATION 1 ar ea.
GRANULATION 2 area.
COMPRESSION AREAS -1(20stn), 2(27stn), 3(29stn), 4(35stn)
COATING AREAS
Sugar Coating area
3 Film coating areas
Proposed Auto Coater Area
PACKING HALL 2 (For Tablets and Capsules)
3 BLISTER Machines
2 STRIP Packing Machines
B}
CAPSULE SECTION .
2 Capsule Filling areas
Blending Area
Filling and Polishing Area 1
Filling and Polishing Area 2
C}
External Preparations (Ointment, Creams, Nasal Drops/ Spray)
OINTMENT SECTION 1
OINTMENT SECTION 2
FILLING PACKING 2
Nasal Drops Department
D}
COSMETICS
Filling Packing 1
D} QUALITY CONTROL AND QUALITY ASSURANCE
DEPARTMENT