API’s and API Intermediates

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.

Facilities:

Derabassi (Punjab):

This facility has nine units manufacturing the oral and sterile range of cephalosporin APIs and intermediates.

Chhachhrauli (Punjab):

Multi block built in a 27 acre site for drugs for manufacturing non-antibiotic APIs in the new therapies such as CVS, CNS, oncology, anti-thrombotic, anti-diabetic and pain management.

Panchkula (Haryana):

This facility has two units manufacturing SSPs and API intermediates such as 6-APA.

Barwala (Haryana):

The World class CRO /CMO centre develops and scales new APIs and API intermediates in all therapeutic segments including non-antibiotic products. It also provides contract research services to innovator companies.

Segments

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
Non-Antibiotics
Intermediates
High Potent Active Ingredients

Our Products

Cephlasporin Oral

Cefuroxime Axetil Cry. / Amp.
Cefuroxime Axetil DC Grade / TMG
Cefpodoxime Proxetil
Cefixime Trihydrate
Cefdinir
Cefprozil
Ceftibuten
Cefditoren Pivoxil
Cefetamet Pivoxil
Cefcapene Pivoxil

Cephalosporin Sterile

Ceftriaxone Sodium
Cefuroxime Sodium
Cefepime+L-Arginine
Ceftazidime
Ceftizoxime Sodium
Cefotaxime Sodium
Cefalotin Sodium
Cefoperazone + Sulbactam
Ceftriaxone Sodium + Sulbactam

Pencillin Oral / Sterile

Amoxycillin Trihydrate
Ampicillin Anhydrous / Trihydrate
Cloxacillin Sodium
Bacampicillin Hcl
Cloxacillin Sodium
Dicloxacillin Sodium
Flucloxacillin Sodium
Oxacillin Sodium
Piperacillin Sodium
Pivampicillin Base
Sultamicillin Base
Sultamicillin Tosylate
Sulbactum Sodium
Tazobactum Sodium
Ampi + Cloxa (1:1)
Ampi + Dicloxa (1:1)
Ampi + Sulbactam (2:1)
Amoxi + Flucoxa (1:1)
Piperacillin + Tazobactam (8:1)

Non Antibiotics

Bosentan
Candesartan
Deferasirox
Febuxostat
Pentosan Polysulfate
Pentazocine
Strontium Ranelate

Herbals

Calcium Sennoside
Colchicine
Raubasine
Reserpine
Thiocolchicoside
Vinpocetine
Yohimbine

Under Development

Azilsartan
Cinacalcet
Glimepride
Montelukast
Saxagliptin
Sitagliptin
Tapentadol
Vildagliptin
Ceftiofur
Cefoxitin Sodium
Cefpirome Sulfate
Cefotiam HCl
Cefazolin Acid Free

Intermediates

7-ANCA
7-APRA
7-AVNA
7-PYCA
Cefpodoxime Acid
Cefuxorime Acid
DAMA
TTA

Manufacturing Facilities

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.

Cephalosporin Facility

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.

Accreditations

- European GMP

- WHO GMP

- ISO 14001-2004

- OHSAS 18001-2007

Penicillin Facility

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.

Regulatory Affairs

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: regulatory@parabolicdrugs.com