Hanumantharao Bommena Email & Phone Number | Ph. D with 16 years of experience in the area of process R&D (API), development of new APIs for fresh DMF/CEP filing for regulated markets (US, EU, Canada, Japan, etc.,) Execution of pre-scale up, scale-up and exhibit/validation batches of the new APIs. Technology transfer from lab scale to kilo lab, pilot plant scale and finally to plant scale for commercial production. Process validation at plant scale to file DMF for regulated markets. Hand on experience in the cost reduction/ Technology improvement of existing DMF filed APIs by Identifying areas of improvement for existing commercialized processes in all divisions with the objective of “increasing throughput, reducing the steps, recovering and recycling of spent solvents, minimizing waste, affluent generation, reducing cycle time, reducing the overheads corrections, recycles and improve process yield, and RM consumption, using cheaper RM’s, by changing the reaction scheme etc.," Expertise in plant-level troubleshooting and also in trouble-free technology development and Technology transfer of API. Expertise in the synthesis of impurities and impurities carry over study/ Genotoxic impurities evaluation / Addressing Regulatory/ customer deficiency queries. Well versed with ICH Guidelines, cGMP, USFDA & Regulatory requirements for various advanced markets like EU, US and Japan, also the regulatory requirements for fresh DMF filing and variation filing of the existing process with FDA on an existing process. Well versed on the DRA requirements on variation filing of the Technology Improved/cost reduction of existing/commercialized/DMF/CEP filed process. Well versed with Para – IV Filing, FTF and also regulatory requirements for Drug Substances. An articulate, dynamic leader with a diverse blend of Process R&D / Process Improvement / Process development, tech transfer, Scale-up expertise of API.

Hanumantharao Bommena

Ph. D with 16 years of experience in the area of process R&D (API), development of new APIs for fres...
Andhra Pradesh, Andhra Pradesh, India

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Hanumantharao Bommena’s Email hanumantharao@caplinpoint.net

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Hanumantharao Bommena’s Location Andhra Pradesh, Andhra Pradesh, India

Hanumantharao Bommena’s Current Industry Extrovis Caplin Point Laboratories

Hanumantharao Bommena’s Prior Industry Azico Biophore | Aurobindo Pharma | Matrix Laboratories | Dr Prems Molecules

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Work Experience

Extrovis

Chief Scientific Officer

2021-02-01 00:00:00 - Present

Caplin Point Laboratories

Assistant General Manager

2020-03-01 00:00:00 - Present

Azico Biophore

Senior Manager

2017-08-01 00:00:00 - 2020-03-01 00:00:00

Aurobindo Pharma

scientist

2010-01-01 00:00:00 - 2017-08-01 00:00:00

Matrix Laboratories

Research Officer

2008-01-01 00:00:00 - 2010-01-01 00:00:00

Dr Prems Molecules

Sr. chemist

2005-05-01 00:00:00 - 2008-01-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Hanumantharao Bommena

Hanumantharao Bommena is located at
Andhra Pradesh, Andhra Pradesh, India

Hanumantharao Bommena is a Ph. D with 16 years of experience in the area of process R&D (API), development of new APIs for fresh DMF/CEP filing for regulated markets (US, EU, Canada, Japan, etc.,) Execution of pre-scale up, scale-up and exhibit/validation batches of the new APIs. Technology transfer from lab scale to kilo lab, pilot plant scale and finally to plant scale for commercial production. Process validation at plant scale to file DMF for regulated markets. Hand on experience in the cost reduction/ Technology improvement of existing DMF filed APIs by Identifying areas of improvement for existing commercialized processes in all divisions with the objective of “increasing throughput, reducing the steps, recovering and recycling of spent solvents, minimizing waste, affluent generation, reducing cycle time, reducing the overheads corrections, recycles and improve process yield, and RM consumption, using cheaper RM’s, by changing the reaction scheme etc.," Expertise in plant-level troubleshooting and also in trouble-free technology development and Technology transfer of API. Expertise in the synthesis of impurities and impurities carry over study/ Genotoxic impurities evaluation / Addressing Regulatory/ customer deficiency queries. Well versed with ICH Guidelines, cGMP, USFDA & Regulatory requirements for various advanced markets like EU, US and Japan, also the regulatory requirements for fresh DMF filing and variation filing of the existing process with FDA on an existing process. Well versed on the DRA requirements on variation filing of the Technology Improved/cost reduction of existing/commercialized/DMF/CEP filed process. Well versed with Para – IV Filing, FTF and also regulatory requirements for Drug Substances. An articulate, dynamic leader with a diverse blend of Process R&D / Process Improvement / Process development, tech transfer, Scale-up expertise of API.

Hanumantharao Bommena currently works in the Extrovis | Caplin Point Laboratories |

No Languages Available

Hanumantharao Bommena has prior
experience in the following industries:
Azico Biophore | Aurobindo Pharma | Matrix Laboratories | Dr Prems Molecules

Hanumantharao Bommena has the following professional experience:
Extrovis | Caplin Point Laboratories | Azico Biophore | Aurobindo Pharma | Matrix Laboratories | Dr Prems Molecules