CONCEPT, BASIC, DETAILED ENGINEERING, PROCUREMENT AND PROCESS INTEGRATION FOR

API PROJECT AT EGYPT

DCPL INTERNATIONAL

Introduction
DCPL International (A Group Company of M/s Doshi Consultants Pvt. Ltd.) was founded in 1986 with a
vision to excel in engineering and consultancy sector. Today with this vision the company stands as one
of the leading engineering firms in the field of pharmaceutical, Biotech, API, Nutraceuticals, Chemicals,
Cosmetics, Food, Education and Hospitality industries.

An India based ISO: 9001-2015 certified company offering:

Turnkey consultancy services for Pharmaceutical, Bio-Tech, Chemical, Food & Allied Industries right
from Concept to Commissioning including validation and inspected and approved by international
regulatory norms such as USFDA, TGA, UKMHRA, ANVISA, WHO GMP,ISO 9000, MCA, cGMP etc.
Providing energy efficient & economical designs with commitment to quality and incorporating a high
degree of customer satisfaction.
Complete In-house setup with several branches in the country.
Creates modern facility combining enormous experience, latest technological advancements in
compliance with the various international regulatory authorities.
Every member of the DCPL family cherishes and takes pride in the values of Honesty, Integrity and
Team Work. These values give us the strength to deliver engineering solutions meeting the highest
quality without any compromise.
DCPL delivers services across the following industry sectors; API’S, Biotech , Finished Dosage Forms
(OSD, Semi Solids, Aseptic Products etc,) Analytical and Microbiology Laboratories, Pilot Plants, R&D
Centers, High Potent products etc. In the process, DCPL has built up a vast body of knowledge related
to the unique requirements of the pharmaceutical industry.

COMMITMENT

We Work on the Basis Of: Client is having option to select services from DCPL.

✓ Concept Engineering

✓ Basic Engineering

✓ Detailed Engineering

✓ Procurement Assistance

✓ Project Management

✓ Validation and Qualification

 COMPLIANCE:

✓ The facility designs will conform to:

✓ Relevant Local / WHO cGMP guidelines.

✓ Relevant engineering standards published by NBS, ASTM etc. as per Good Engineering Practices.

✓ ISO 14644 guidelines (HVAC Systems).

✓ Relevant local statutory/ regulatory and cGMP requirements.

✓ EPA and HSE standards.

✓ ISPE Guidelines.

Project Objective
M/S Pharma Tau would like to establish API Plant at Egypt.
Planning to set up 5 Blocks:
a. Block 1 : Multipurpose API General products : 10 KL / 6K L

b. Block 1A : Multipurpose API General products : 3 KL / 1 KL / 0.5 K L

c. Block 2 : Metformine – 1000 MT / year

d. Block 3 : Paracetamol

e. Block 4 : Excipients

f. Block 5 : R & D
 PRODUCT LIST AND THEIR PRICES
1 Levetiracetam $70,000
2 Sitagliptin $70,000
3 Pantoprazole $42,000
4 Povidone Iodine $42,000
5 Levofloxacin $42,000
6 Vildagliptin $56,000
7 Febuxostat $140,000
8 Valsartan $56,000
9 Azithromycin $42,000
10 Orlistat $70,000
11 Benfotiamine $63,000
12 Fexofenadine $63,000
13 Mebeverine $168,000
14 Rosuvastatin $84,000
15 Atorvastatin $84,000
16 Levocetirizine $84,000
17 Chlorohexidine $42,000
18 Cetrimide $56,000
19 Chlorthalidone $84,000
20 Empagliflozin $168,000
21 Dapagliflozin $168,000
22 Imeglimin $70,000
23 Tadalafil $56,000
24 Obeticholic Acid $56,000
25 Vonopazan $84,000
26 Bempodic Acid $56,000
27 Brivaxetam $84,000
28 METFORMIN HCL $56,000
29 PARACETAMOL $56,000

Scope of services of M/s DCPL international

COMPLETE ENGINEERING& DESIGN SERVICES

✓ Master Site Planning

✓ Concept Engineering

✓ Basic & Detailed Engineering

✓ Process Engineering and Procurement of Process Equipments.

 -CONCEPT DESIGN Page 7
-Basic & Detailed Engineering Page 8
-Utility Engineering Page 9
-Piping Engineering Page 9
-Instrumentation Engineering Page 10
-HVAC Page 10
-Modular Clean Room Panels Page 11
-QC( Chemical , Page 11
Instrumental,Microbiological,Laboratory
)
Process Engineering, Intergration and Page 12
equipment
Part 5: Procurement of engineering and Page 12
Process equipments

OWNER’S OBLIGATIONS

In order to enable DCPL to provide the engineering services, DCPL has assumed that PHARMA TAU will
responsible for the following activities in such a way as to be compatible with agreed completion
schedule.

Appoint a Project Manager as a single point coordinator of M/S PHARMA TAU to work together with the
DCPL project manager at site to accompany the planning work and to participate in the workshops
 VISIT CHARGES FOR REVIEW MEETING, FAT, VENDOR QUALIFICATION AND EXHIBITIONS
DCPL Team from India
DCPL Associates/ SME from Germany / Any
other company (If require):
Visit of our Local Representative in Egypt US$ 150 per day per person + conveyance cost
Design And Engineering
Site Supervision
Fat Services
Man DAY Rate For change Control
Mode Of payment
Drawing / Document Approval:
Validity
Standard Terms &Conditions
US$ 300 per day per person
US$ 750 per day per person
extra.
Page 16
Page 16
Page 16
Page 16
All payments shall be made within 15 days of
submission of invoice by LC / electronic transfer.
If not Paid it will attract additional15% interest
after 15th day of Invoice till the date of payment.
Once the drawings / documents are submitted by
DCPL and you will send comments within 7 days
otherwise all submitted drawings and documents
deemed to be considered as approved and we
will proceed for next stage of work.
Our offer is valid for 30 days from the date of the
offer and is subject to our confirmation
thereafter.
Additional Work / Extra Services Following
receipt by DCPL of M/S PHARMA TAU’s written
instructions during the existence of the Purchase
Order, DCPL shall provide services to M/S
PHARMA TAU, additional to “Scope of
 Services/Work” under this Purchase order in
accordance with all the provisions thereof at a
rate of USD 150 / Hr.
Taxes and Duties All taxes, duties & levies
(prevailing & applicable in future) and bank
charges as applicable shall be borne by M/S
PHARMA TAU. All the Government Charges, Govt.
Taxes, Bank Charges on the above Purchase
Order will be paid by the client. The same should
not be deducted from the Invoice / Bill from
DCPL.
Delays & Extensions DCPL’s fees are based on work being initiated not
later than two months from the date of the order
and completed no later than 18 months from the
date of the order.
If the aforesaid time schedule is extended due to
any reason whatsoever nonattributable to DCPL,
DCPL’s unbilled fees will be subject to an
escalation of 5% (five percent) per month for the
following 12 months period.
 PROPOSAL FOR TECHNOLOGY TRANSFER
We will be able to support you directly on a Turn-Key basis in your Pharma Project from Process
Development to Technology Transfer at commercial scale for all APIs except some APIs in Phase-IV; we
will confirm the status of these APIs at a later date.

PROCESS TECHNOLOGY

We offer Process technology by the batch process. The complexity of Chemistry and the key starting
raw material (KSM) will determine the cost of Process Technology. We will finalize the KSM of each API
on the basis of Supply Chain Security and Economic Viability& where necessary, backward integration
into the KSMs will be incorporated.

SCOPES OF SERVICE
Details of the broad heading of the Scope of Services for Process Technology of all API are given below:

PHASE 1 Process Know-How Package. Refer the content of

Process Know-How Package.
PHASE 2 . Technology Transfer of at the Laboratory Level
through Demonstration of three consecutive
batches (minimum), validating the Quality, Yield
& Raw Material Consumption Norms along with
generating samples for marketing.
PHASE 3 Technology Transfer at Commercial level through
Plant Demonstration at the New Manufacturing
Facility for Yield, Quality & Raw Material
Consumption Norms for a minimum of 3
consecutive batches