API's and API Intermediates
Parabolic Drugs Limited- One of The Leading Api Manufacturers of The Nation
In the pharmaceutical business, the role of manufacturing and operations need to be over emphasised as products affect human lives. In view of this, the Company invested in the highest standards of manufacturing excellence.
The Company is engaged in the manufacture of APIs and API intermediates for sales in India and abroad (including regulated markets).
Broadly the company operates into the following segments:
Semi Synthentic Penicillins-Oral and Sterile
Cephalosporins - Oral and Sterile
High Potent Active Ingredients
Parabolic Drugs has invested ambitiously in developing World Class manufacturing facilities with operational excellence.
Parabolic Drugs has three state of the art manufacturing facilities across different locations and a world class CRO/R&D centre at Barwala. Its manufacturing facilities are well equipped to produce quality products while adhering to safety norms and stringent GMP compliance.
PDL’s Cephalosporin facility at Derabassi is a 27 acre site accredited by German MOH for European Good Manufacturing Practices.
This site has nine manufacturing plants that enables it to produce wide range of latest generation cephalosporin APIs and intermediates. It also has a dedicated quality control and quality assurance unit, solvent recovery units, three R&D laboratories, a pilot plant for scale-up of new technologies developed by our in-house R&D, three boilers and utilities, two warehouses and in house healthcare centre.
- European GMP
- WHO GMP
- ISO 14001-2004
- OHSAS 18001-2007
Commissioned in fiscal 2005, the Panchkula facility houses two dedicated blocks for the manufacturing of wide range of oral penicillin products including niche penicillin APIs such as Bacampicillin, Sultamycillin and Pivampicillin The plant complies with all GMP requirements and has complete utility support with ETP, an in-house liquid nitrogen tank, and a GMP compliant water systems and chillers.
Non- Antibiotic Facility
The facility has commissioned for manufacturing non-antibiotic APIs in the new therapies such as CVS, CNS, oncology, antithrombotic, anti-diabetic and pain management. It includes QA/QC block, pilot plant, manufacturing plant with five production streams, separate finished goods processing section, solvent recovery, utilities, effluent treatment plant, canteen, stores, warehouses, hazardous reaction block and engineering and project sections.
Parabolic Drugs Limited aims to increase its presence in the regulated markets. The Company is striving to get quality accreditations for its products, systems, procedures and safe environment, prerequisites for the regulated markets.
Apart from this, the Company has an ambitious plan for filing of Drug Master Files (DMF) for its API being manufactured by a noninfringing process. Both the Panchkula facility and the Derabassi site are registered in the USA with US FDA, as manufacturers and suppliers of quality API and intermediates.
There are currently 39 DMFs filed in Europe, the USA Japan and Canada, for registration of the Company’s API. It has also received for certificates of Suitability (COS) for its key molecules.
For details on the DMF filing and our regulatory strength , please feel free to contact us at: firstname.lastname@example.org
Accreditations for Our Facilities
The following are the current valid certifications for Company’s facilities:
Accredited as a Certified Foreign Manufacturer from Japanese PMDA
US FDA for 6-APAs at Panchkula
OHSAS 18001-2007 by DNV for Occupational health and safety management systems
Facility Approval by various customers including leading national and International Pharma MNCs.