anuh pharma lt d. programme for the i… · the factory to familarise the independent directors of...

35
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Page 1: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

A

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Page 2: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

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Page 3: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

ANUH PHARMA LIMITED

FAMILARISATION PROGRAM FOR INDEPENDENT DIRECTORS

FOR THE FINANCIAL YEAR 2016-17

Head Office: 3-A, Shiv Sagar Estate, North Wing, Dr. Annie Besant Road, Worli, Mumbai - 400 018

Factory: E 17/3 & 17/4, MIDC, Boisar, Tarapur, Palghar - 401 506

ANUH PHARMA LIMITED

Page 4: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

FAMILARISATION PROVISIONS

• Pursuant to Regulation 25(7) of the SEBI (Listing Obligations

and Disclosure Requirements) Regulations, 2015 the listed

entity shall familiarise the Independent Directors through

various program about the listed entity, including the

following:

• Nature of the industry in which the listed entity operates;

• Business model of the listed entity;

• Roles, rights, responsibilities of Independent Directors; and

• Any other relevant information.

ANUH PHARMA LIMITED

Page 5: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

KEY INITIATIVES

• Presentation shall be made regarding role & responsibilities of

Independent Directors and regarding factory activities and operations of

the factory to familarise the Independent Directors of the Company’s

business model and how the factory runs as & with their roles and

responsibilities.

• Visit to Company’s plant shall be organized for all the Independent

Directors, where plant Heads appraise them of the operational and

sustainability aspects of the plants to enable them to have full

understanding on the activities of the Company and initiatives taken on

safety, quality, Sustainability etc.

• Periodical presentations on operations shall be made to the Board which

shall include information on business performance, operations, market

share, financial parameters, working capital management, fund flows,

senior management change, major litigation, compliances, CSR donations,

regulatory scenario etc.

ANUH PHARMA LIMITED

Page 6: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

ROLES, RIGHTS, RESPONSIBILITIES

OF INDEPENDENT DIRECTORS

• Section 149, 150 and Schedule IV of the Companies Act,

2013 governs the rules, regulations, duties, role and

functions of Independent Directors:

• The Independent Directors shall:

� help in bringing an independent judgment to bear on the Board’s

deliberations especially on issues of strategy, performance, risk

management, resources, key appointments and standards of conduct;

� bring an objective view in the evaluation of the performance of board and

management;

� participate constructively and actively in the committees of the Board in

which they are chairpersons or members& strive to attend the general

meetings of the company.

ANUH PHARMA LIMITED

Page 7: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

ROLES, RIGHTS, RESPONSIBILITIES

OF INDEPENDENT DIRECTORS

� determine appropriate levels of remuneration of executive directors, key

managerial personnel and senior management and have a prime role in

appointing and where necessary recommend removal of executive

directors, key managerial personnel and senior management;

� scrutinise the performance of management in meeting agreed goals and

objectives and monitor the reporting of performance

� seek appropriate clarification or amplification of information and, where

necessary, take and follow appropriate professional advice and opinion of

outside experts at the expense of the company

� not disclose confidential information, including commercial secrets,

technologies,advertising and sales promotion plans, unpublished price

sensitive information, unless such disclosure is expressly approved by the

Board or required by law

ANUH PHARMA LIMITED

Page 8: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

ABOUT US

• Anuh Pharma’s manufacturing activities are carried out under Licence

from the Food & Drug Administration, Maharashtra State, India and

covered by manufacturing Licence No. 28 KD-990 & 25 KD 1194

• Global presence in 57 countries as exporter.

• Government recognised export house for last ten years.

ANUH PHARMA LIMITED

Page 9: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

PRODUCT LIST

• Macrolides

ITEM SPECIFICATION PACKING CAS NO USE

Erythromycin Base IP/BP/USP/CP/EP 25 Kg HDPE Drum 114-07-8Antibacterial

Erythomycin Estolate IP/BP/USP/EP 25 Kg HDPE Drum 3521-62-8lAntibacterial

Erythromycin Ethyl

SuccinateBP/USP/EP 25 Kg HDPE Drum 41342-53-4 Antibacterial

Erythromycin

PropionateFP 25 Kg HDPE Drum 134-36-1 Antibacterial

Erythromycin Phosphate IN HOUSE TESTING 25 Kg HDPE Drum 4501-00-2 Antibacterial

Erythromycin Stearate IP/BP/USP/EP 25 Kg HDPE Drum 643-22-1 Antibacterial

Erythromycin 11,12

CarbonateIN HOUSE TESTING 25 Kg HDPE Drum 55224-05-0 Antibacterial

ANUH PHARMA LIMITED

Page 10: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

PRODUCT LIST

ANUH PHARMA LIMITED

ITEM SPECIFICATION PACKING CAS NO USE

Erythromycin

Oxime BaseIn House 25 Kg HDPE Drum 13127-18-9 Intermediate

Erythromycin

Silyl EsterIn House 25 Kg HDPE Drum 119665-76-8 Intermediate

Erythromycin

Imino EtherIn House 25 Kg HDPE Drum 99290-97-8 Intermediate

• Intermediates

Page 11: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

PRODUCT LIST

• Higher Macrolides

ITEM SPECIFICATION PACKING CAS NO USE

Azithromycin BP/USP 25 Kg HDPE Drum 83905-01-5Antibacterial

ANUH PHARMA LIMITED

Page 12: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

PRODUCT LIST

• Chloramphenicol

ITEM SPECIFICATION PACKING CAS NO USE

Chloramphenicol IP/BP/USP/EP 25 Kg HDPE Drum 56-75-1 Antibacterial

Chloramphenicol Palmitate IP/BP/USP/EP 25 Kg HDPE Drum 530-43-8 Antibacterial

ITEM SPECIFICATION PACKING CAS NO USE

Pyrazinamide IP/BP/USP/EP 25 Kg HDPE Drum 98-96-4 Antituberculousis

Sulfadoxine IP/BP/EP 25 Kg HDPE Drum 2447-57-6 Antimalarial

Ofloxacin IP/BP/USP 25 Kg HDPE Drum 82419-36-1 Antibacterial

Losartan Potassium IP/BP/EP/USP 25 Kg HDPE Drum 124750-99-8 Antihypertensive

ANUH PHARMA LIMITED

Page 13: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

ORGANOGRAMBIPIN SHAH

((MANAGING DIRECTOR)

BIPIN SHAH

((MANAGING DIRECTOR)

Dr. Rajendra Agrawal

(V.P. Technical)

Dr. Rajendra Agrawal

(V.P. Technical)

Girish Mandlekar

(General Manager - Works)

Girish Mandlekar

(General Manager - Works)Surendra Rai

(AGM – Q.C.)

Surendra Rai

(AGM – Q.C.)

Nilesh Mohare

(AGM Q.A.)

Nilesh Mohare

(AGM Q.A.)

Babu Moghaveera

(AGM Tech)

Babu Moghaveera

(AGM Tech)

Nilesh Jadhav

(HRD Incharge)

Nilesh Jadhav

(HRD Incharge)

Bhavesh Mudaliar

(Production

Incharge)

Bhavesh Mudaliar

(Production

Incharge)

Shift Chemists Shift Chemists

Warehouse

Clerks

Warehouse

Clerks

H.R. H.R.

Chandrakant Pate

Asst. QC – In-charge

Chandrakant Pate

Asst. QC – In-charge

Assistant QA

Manager

Assistant QA

Manager

Chemists Chemists

Sanjay Godambe

(AGM Admin)

Sanjay Godambe

(AGM Admin)

Ganesh Vachkal

(Maintenance

Incharge)

Ganesh Vachkal

(Maintenance

Incharge)

Jr. EnggJr. Engg

Mechanic/Fitters Mechanic/Fitters

QA Officers

K.D.

Dhanawde

(EHS Officer)

Maintenance

SupervisorsShift Incharge

Direct Reporting

Administrative Reporting

Page 14: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

• The plant is situated at Plot No. E-17/3 & 17/4, Tarapur Industrial Area,

M.I.D.C., Boisar, - 401 506 Maharashtra (India).

• It is about 125 km from Mumbai.

• The Plot area is 3600 Sq. M.

• The plant has been designed & constructed to meet GMP guidelines.

• The Facility has been approved by WHO GMP for Pyrazinamide &

Sulfadoxine & EU GMP for Pyrazinamide & Erythromycin Ethyl succinate.

• The facility has been approved by COFEPRIS (Mexico) for Erythromycin

Base, Erythromycin ethyl succinate, Erythromycin stearate,

Chloramphenicol & Chloramphenicol palmitate.

• The facility has been approved by Indian FDA & has been granted local

GMP Certificate.

• Products manufactured by this facility has been granted with written

confirmation for export to European union by CDSCO (Govt. Of India)

ANUH PHARMA LIMITED

Page 15: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

ANUH PHARMA LIMITED

Page 16: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

TOTAL BUILT UP AREA IN SQ. METERS

Change Rooms 37.30

Production Area 1367.00

Warehouse 513.80

Quality Control 104.80

Quality

Assurance

41.29

ETP 15.30

AHU Area 180.55

Total 2154.44

ANUH PHARMA LIMITED

Page 17: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

ANUH PHARMA LIMITED

Capacity

1. Total reactor capacity is 50,000 L

Sr No. Name of Product Capacity Per

Annum

1 Macrolides & Intermediates 1000 Metric Ton

2 Pyrazinamide 500 Metric Ton

3 Chloramphenicol 100 Metric Ton

4 Ofloxacin 250 Metric Ton

5 Sulphadoxine 100 Metric Ton

6 Losartan Potassium 50 Metric Ton

Page 18: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

The site comprises of two blocks.

ANUH PHARMA LIMITED

Block - 1 comprises of :

1. Administration Area

2. Quality Control

3. Quality Assurance

4. Two Dedicated Manufacturing Plants

5. Two Dedicated Air Jet Milling Rooms

Block- 2comprises of :

1. Four Dedicated Manufacturing

Plants

2. Warehouse

Page 19: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

Quality Control Lab.

• Anuh Pharma Ltd. currently has 7 HPLCs, 2 GC, 1 UV Spectrophotometer,

1 FTIR and 4 Stability Chambers.

• It also has a Microbiology section which has separate primary and

secondary change rooms, and different rooms for Autoclave, Incubators

and Laminar Air Flow units.

ANUH PHARMA LIMITED

Page 20: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

Dedicated Manufacturing Facilities

Ground Floor :

• The ground floor houses 9 dedicated powder processing areas.

• It houses Centrifuge Area, Drying Area, Milling & Sieving, Blending and

Packing rooms.

ANUH PHARMA LIMITED

Page 21: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

First & Second Floor :

• The first and second floor houses the synthesis area.

• The synthesis area houses Reactors with Condensers,

Charging Vessels, Sparkler Filters, Pumps etc.

ANUH PHARMA LIMITED

Page 22: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

MANUFACTURING FACILITY

ANUH PHARMA LIMITED

Warehouse :

• Raw Material, Packing Material & Finished Goods are stored here.

• 2 Lifts for the movement of Raw Materials, Packing Materials and Finished

Products between levels are provided.

• Dedicated temperature controlled areas for specific Raw Materials and

Finished Goods are provided.

• The entire passage area is provided with

with Forced Draft Ventilation.

• Separate dispensing and sampling rooms

with Reverse Laminar Airflow are provided.

Page 23: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

Purified Water Plant

ANUH PHARMA LIMITED

Purified Water Loop System :

• In its effort to provide good quality medicines Anuh Pharma Ltd. Has

commissioned a Loop System for distribution of Purified Water IP/BP/EP in

the manufacturing facility.

• The Loop System continuously circulates the Purified Water IP/BP/EP in the

plant through SS 316 mirror polished pipelines and zero dead-lag valves so

as to completely avoid stagnant water hold up and related growth of

microorganisms.

• The Loop System has been setup as per cGMP Guidelines.

Page 24: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

QUALITY POLICY

• Manufacturing of Active Pharmaceuticals Ingredient is governed by the

philosophy of Current Good Manufacturing Practices also known as cGMP.

These guidelines cover all the aspects of pharmaceutical manufacturing,

storage and distribution, and are aimed at providing quality

pharmaceuticals Ingredients to the user pharmaceuticals formulation

manufacturing companies.

• Being a firm believer in the cGMP philosophy, Anuh Pharma Ltd. strives for

its implementation in all the operations involved.

• The company’s policy is to ensure that all products are manufactured to

the appropriate Quality and the buyer can trust the product as being

consistent in Quality, Reliability and Safety for the purpose for which it is

intended.

• To achieve this objective, a Quality Assurance System has been developed

and installed to which Management will give their full support.

• We are also committed to continually improve effectiveness of our quality

management system & ensure that the basic principles of cGMP shall

always be adhered to during manufacturing & distribution activities.ANUH PHARMA LIMITED

Page 25: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

EHS POLICY

ANUH PHARMA LIMITED

…Contd

• For manufacturing those we shall carry out all the operations in safe manner, follow

cGMP and assuring compliance of all legal requirements and achieve for the purpose

for which it is intended.

• We believe that all the accidents, occupational health hazards are preventable.

• Conduct all its activates in such a manner as to avoid harm to employees, contractors

and the community.

• Utilize energy resources in a responsible and efficient manner so as to reduce

emissions and generation of effluent and waste product.

• Comply with all statutory requirement concerning health, safety and Environment.

• Effective use of safe working procedure and practices for operation maintenance,

inspection and emergency situation.

• Regular review of these safe working procedures.

Page 26: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

EHS POLICY

ANUH PHARMA LIMITED

BIPIN SHAH

Managing Director

• Providing the personal protective equipments, tools and tackles to conduct all works

in a safe manner and to ensure integrity of the assets.

• Investigating all incidents relating to Health, Safety and Environment including minor

ones and near misses followed by the implementation of corrective measures.

• Identifying and evaluating Health risk related to its operations and carrying out pre-

employment and periodic medical check up of its employees.

• Interaction with local communities regarding its operations, likely hazards and

emergency response system.

• We are also committed to continually improve effectiveness of our safety policy and

will strive for its implementation in all the operations involved.

Page 27: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

R&D Division

1. "Research & Experience" these two values from the foundation of our

growth and success. With Experience comes Expertise and Knowledge, but

in an industry that has one of the fastest rates of innovation and

technological advances it is Research that differentiates leaders in our

industry. Experience needs to be Empowered by Research.

2. Spread across 10,000 square feet in Navi Mumbai, this laboratory has three

sections: the Analytical Development lab, Chemical Synthesis Lab and a

Pilot Plant. In addition to these facilities the lab derives benefit from the

services of excellent professionals and experienced advisors. Our sound

infrastructure and systems ensure smooth working of the lab. We receive

30 KVA Uninterrupted Power Supply and we have a 120 KVA diesel

generator to ensure continual undisturbed reactions. The Effluent

Treatment Plant adheres to environment friendly guidelines. In fact, we use

all the treated water for gardening purposes thereby reducing the lab’s

carbon footprint.

ANUH PHARMA LIMITED

Page 28: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

R&D Division

ANUH PHARMA LIMITED

Page 29: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

CERTIFICATES

ANUH PHARMA LIMITED

Star Export House

Page 30: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

CERTIFICATES

ANUH PHARMA LIMITED

WHO CERTIFICATE

Page 31: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

CERTIFICATES

ANUH PHARMA LIMITED

EU GMP CERTIFICATE

Page 32: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

CERTIFICATES

ANUH PHARMA LIMITED

COFEPRIS GMP Written Confirmation - CDSCO

Page 33: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

CERTIFICATES

ANUH PHARMA LIMITED

Written Confirmation - CDSCO Written Confirmation - CDSCO

Page 34: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

AWARDS

ANUH PHARMA LIMITED

Best Exporter’s Award

By Vice Presedent of India

Best Exporter’s Award (2003 - 2004)

By Commerce Minister, Govt. of India

Best Exporter’s Award (2002 - 2003)

By Commerce Minister, Govt. of India

Page 35: ANUH PHARMA LT D. Programme for the I… · the factory to familarise the Independent Directors of the Company’s business model and how the factory runs as & with their roles and

Thank You.

ANUH PHARMA LIMITED