© 2018 by Shamrock. All Rights Reserved.

 

MANUFACTURING OPERATIONS

 

Production Facilities

Our manufacturing locations for API’s and Intermediates are as per cGMP standards and conforming to USFDA and European GMP standards along with ICHQ7 guidelines.

Most of the locations have also obtained ISO 9000 and ISO 14000 certification. 

The units are designed in a manner that it can be dedicated plants as well as multipurpose plants executing various processes and reactions.

 

Contracting Manufacturing

As part of our key production focus plan, we are engaged in Contract Manufacturing with other facilities in India and China. Contract Manufacturing is done mostly on a product exclusive basis and the facility produces the product exclusively for Shamrock Group of Companies.

We provide and assist these units with raw materials, technology transfer, financing and 100% marketing. Such arrangement facilitates a wide range of products and contract manufacturing worldwide.

 

Pilot Plant & 

Plant Equipment

We use the Pilot Plants for constant improvisation of processes and carrying out trials for new products as well as adding value to basic chemistry. Our production facilities also undergo constant updating to fulfil the manufacturing quality standards of the FDA. Our endeavour and focus has been in the ‘Basic Backward Integration’ by producing the intermediates and raw materials from the basic stage. 

 

Quality Assurance & Quality Control 

Apart from checking and controlling the quality, Our Quality Assurance Department satisfies all customer requirements. We have a fully advanced and integrated Quality Control Laboratory where all the equipments are calibrated and validated periodically. 

 

Regulatory Affairs

Our Regulatory Affairs Division provides for all technical documentation and validation support with respect to all our APIs, advanced Intermediates, Intermediates and Fine Chemicals. Our division provides for complete breakdown analysis for each molecule and documents the same in the required format to include the following support:

 

  1. Route of synthesis/Non infringing and patent evaluation.

  2. NROs filing of preliminary documentation and validating the same with the batch process

  3. Drug master file as per EDQM, USFDA and other regulatory authorities

  4. Impurity profile complying to ICH guidelines (organic and inorganic residual solvents), MOA validation and all parameters in addition to official Pharmacopoeia.

  5. Stability studies and data under various temperature conditions.

  6. Reference working and impurity standards and isolation of the same.

  7. Toxicity Data/BSE/TSE/MSDS

  8. Registering dossiers for formulations and APIs.

  9. Bioequivalence. Bioavailability studies approved by European and other developed countries.

 

Reaction Capabilities

  • Acid Chlorides

  • Acylations

  • Alkylations ( O & C Alkylations)

  • Amidation

  • Amide Hydrolysis

  • Asymmetric Synthesis

  • Benzoyfation

  • Bromination

  • Cannizzarro

  • Chlorination

  • Chlorosulphanation

  • Claisen Caondensation

  • Condensation

  • Cyanation

  • Cyclization

  • Demethylation

  • Diazolisation

  • Enztmatic Reaction

  • Esterification

  • Fermentation

  • Formylation

  • Friedel-Crafts

  • Fries Rearrangement

  • Sulphonation

  • Grignard

  • Hydrogenation

  • Manufacture of Thio Compounds

  • Methylation

  • Nitration

  • Optical Isomer Separation

  • Phase Transfer Reaction

  • Reductions (NaBH4, LiAIH4-Selectride)

 

Environment Health

& Safety

At Shamrock, health and safety is a prime concern and a Standard Operating Procedure is followed. All the equipments and plants are designed as per the safety norms and standards and effective fire fighting systems are installed. Over and above this, all the employees are well trained at different levels and made to understand all the safety concerns.