JRC PHARMA

A TRULY API’s & INTERMEDIATES

MANUFACTURING COMPANY

JRC strength over 5 years in science and technology that includes synthetic organic chemistry, process research, and scale-up from laboratory to commercial scale along with quality and regulatory support.

JRC offer manufacturing of APIs and Intermediates, developing building blocks for various drug molecules and processes involving complex chemistry.

JRC believes in achieving the highest ethical standards in business.

We strive to understand and meet customer needs in a professional and responsive manner. Our priority is to build long-term partnerships.

JRC supports customers with commercially viable and scalable APIs processes for life cycle management involving second-generation processes. By choosing JRC as a manufacturing partner customers can expect to get quality products, services and assurance of supply meeting necessary applicable regulations.

JRC skilled in innovative synthesis process combined with our knowledge and understanding of the handling of hazardous chemicals and reactions, make us a partner of choice for custom synthesis services and generic active pharmaceutical ingredients (API). We provide bespoke and exclusive development of chemical processes for new and complex molecules, as well as all of the analytical and regulatory assistance required.

JRC strength lies in its ability to partner with from early stage and through out the life cycle of the products, with speed and efficiency in order to maintain their competitiveness.

We have ability to carry out complex and hazardous operations safely.

JRC is able to provide a wide range of synthetic chemical reactions like:

IODINATION

CHIRAL CHEMISTRY

BROMINATION

FRIDEL CRAFT REACTION

ESTERIFICATION

CONDENSATION

CHLOROSULFONATION

HIGH PRESSURE HYDROGENATION

WIDE RANGE OF EQUIPMENT TO SATISFY CUSTOMERS’ REQUIREMENTS

JRC customers can count on an experienced team of highly trained technical personnel, as well as a wide range of available equipment solutions to satisfy their requirements.

Reactor volume : about 40m3 (range 0.5-6 m3, SS/glass lined)

Operating temperature range : -20°C to +150°C

Pressure rating from : full vacuum up to 5 bar

Specific technologies : Dimethyl Sulphate, Grignard, Thionyl Chloride, Isobutylene, Fridel Craft,

Iodine, Bromine & Sodium metal.

Purified water plant : demonized water with RO.

Finishing areas : Bentrifuges, driers & mills in clean rooms with filtered air by HVAC system.

PRODUCT NAME

GMP CERTIFICATE

OPEN PART DMF

CEP CLOSE PART DMF

PIDOTIMOD ACTIVE ACTIVE ---- -----

ACECLOFENAC ACTIVE ACTIVE ---- -----

DIATRIZOIC ACID ACTIVE ACTIVE ---- DEC 2016

FEXOFENADINE HCL

ACTIVE ACTIVE ---- ----

IOHEXOL ACTIVE ACTIVE ---- ----

CILNIDIPINE ACTIVE ACTIVE ---- ----

IOPAMIDOL ACTIVE ACTIVE ---- JAN 2017

PREGABLIN ACTIVE ACTIVE ---- ----

DICLOFENAC SODIUM

ACTIVE ACTIVE ---- ----

COMMERCIAL/ REGULAR PRODUCT

ENTACAPONE MILNACIPRAN VENLAFLAXINE

OXYBUTYNIN HCL ETORICOXIB NEBIVOLOL

NICRDIAPINE HCL DULOXITINE HCL GLIBENCLAMIDE

MECLIZINE HCL SAXAGLIPTINE ZONISAMIDE

DIVALPROAX SODIUM ATOVAQUONE CAPTOPRIL

DEXVENLAFAXINE HCL DONEPEZIL

AGOMELATINE NIFEDIPINE

LACOSAMIDE GRANISETRON HCL

SODIUM VALPROATE NADIFLOXACIN HCL

VALPROIC ACID METOPROLOL SALTS HYDROCHLORO PHTHAZIDE

DEXTROMETHORPHONE HBR

BETHNICOL HCL AMLODIPINE BESYLATE

Quality is one of our core values and as such, we invest substantial attention and resource to ensure that we support our continuous improvement process and culture in this area.

Every day we work to:

• provide high quality products and professional services to

the global pharmaceutical industry through our skilled

people and systems • exceed regulatory requirements and the expectations of our

customers.

An experienced and qualified team is present to maintain compliance with cGMP and regulations. The corporate quality management team ensures consistency, sharing of best practices and continuous quality system improvement in our sites.

Well equipped, state of the art laboratories perform comprehensive tests according to the Pharmacopoeia (e.g.: EP, USP, BP, ),in house developed analytical methods, and customers requirements. Our staff of chemists has an extensive knowledge and expertise in validating analytical methods for raw materials, API’s and cleaning procedures in compliance with the current ICH and FDA guidelines. ICH stability studies, stress tests and forced degradation studies are also performed to guarantee the long-term quality of our products.

In order to support our constant improvement process, our quality performance is internally monitored with a set of broadly based measures. These measures are collected and reviewed by the quality teams and monitored by corporate management to identify and understand any trends, potential issues and most importantly to ensure that any necessary preventive actions are taken to guarantee the quality, continuous improvement and the success of our business.

Our quality systems are fully compliant with ICH Q7 guidiline. Our successful inspection track record, evidence of our commitment and ability to maintain quality systems that satisfy the rigorous standards set by regulatory agencies.

In addition our customers, including the top pharmaceutical companies regularly visit our facilities in order to verify the compliance with cGMP, legal requirements and their own standards. The customer audit provides us with exposure to the latest industry trends, which we view as very good drivers for constant improvement in our quality system.

THANK YOU