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Manufacturing Unit

Manufacturing Unit

A. General information

A.1

Brief information on the site


SHARMA established in the year 1992. We are the foremost manufacturer & exporter of an all encompassing range of Orthopedic Implants. Catering to the discerning needs of the Implants industry, our range is reckoned for quality & innovation.

SHARMA itself has a progressive, professionally managed, Orthopedic Implants (Medical Device) company. SHARMA strongly believes in building quality into the products with the help of a highly qualified, competent and committed manpower.

SHARMA with its latest technologies strives to provide high quality medical devices that improve the health of the end users. Teams of personnel from various disciplines are working towards meeting the customer’s requirements and to fulfill our objective of providing top quality products.

In order to furnish wide variety of orthopedic implants, we offer a wide range of orthopedic implants in stainless steel 316L, 316LVM and Titanium Alloy which includes Spinal Implants, Prosthesis and Joint Replacement (Cemented & Un-Cemented), Bone Plates and Bone Screws (Locked/ Non Locked), Cannulated Cancellous Screws, Interlocking Nails, Locking Bolts And Accessories, Oral Maxillofacial Implants, Aurthoscopy Implants, Pins And Wires, External Fixator

A.2

Manufacturing activities of the site.


The Sharma Pharmaceutical‘s manufacturing facility is specially designed for the manufacturing of Orthopedic Implants (Medical Devices) for human use only. All operation like testing, manufacturing, packing and distribution carried out in same site.

Manufacturing activities as licensed by the national authority (Appendix: 1)

SHARMA manufacturing facilities have a valid manufacturing license (Mfg. Lic.), No. G/28/1302, issued on dated 11.05.2012 by the FDCA Gandhinagar, and valid up to 11.05.2017 for the manufacturing of the following products. (List in Appendix: 2)

In order to furnish wide variety of orthopedic implants, we offer a wide range of orthopedic implants in stainless steel 316L, 316LVM and Titanium which includes locked plates, locked screws, bone plates, bone screws, interlocking nails, spinal implants just to name a few.

The manufacturing facility of SHARMA recognized and approved on different quality standards:

§ Food and Drug Control Administration (FDCA), Gandhinagar, Gujarat

§ Good Manufacturing Practice (GMP), Gujarat State. India (Appendix:3)

§ International Standard Organization (ISO)- 9001:2008 (Appendix:4)

§ International Standard Organization (ISO)-13485:2016 (Appendix:5)


Any other manufacturing activities carried out.



 

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Our Machinery

Our Machinery

Our current location holds more than 40 automatic machines (MADE IN INIDA, USA/GERMANY/JAPAN) with modern technology and fully automatic such as CNC Swiss Turn, Vertical Machining Center CNC 5 Axis, CNC 4 Axis, CNC 3 Axis CNC (Thread Milling Machine & Turning Machine, Water Jet Cutting Machine, Robotic Polishing Machine, Ultrasonic Cleaning Machine, Laser making Machine Conventional Lathe & Milling machines.

 

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Wide Distribution Network

Sales/distributor network - distributing in almost 47 countries.

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