RADHESHYAM KALE
chennai
Summary
Formulation & Development leader with almost 19 years of experience taking pharmaceutical, nutraceutical, and excipient products from lab concept to commercial launch across US, EU, UK, and Indian markets. Delivered 18+ solid oral and liquid formulations—including complex Para IV, ANDA, and 505(b)(2) filings—across major US & EU. Skilled in Quality by Design (QbD), bioequivalence (BE) execution, exhibit batch scale-up, and cross-functional coordination across IPR, Regulatory Affairs, Analytical Development, QA/QC, and Production to meet filling timelines.
Overview
19
19
years of professional experience
Work History
General Manager – Formulation & Development (FR&D)
Kawman ExAct Ingredients Private Limited
Chennai, Tamil Nadu
12.2023 - Current
- Direct R&D strategy and formulation pipelines for pharmaceuticals, nutraceuticals, and value-added excipients serving Domestic and ROW markets.
- Formulated and stabilized direct-compression Antihypertensive granules (28.88% and 18.41% strengths) and Spray-Dried Mannitol, matching marketed grades in compressibility and performance.
- Developed stable, water-dispersible nutraceutical formulations—including Coenzyme Q10, Vitamin B12, Beta-Carotene Alginate Beadlets, Alpha-Lipoic Acid, L-Carnitine, and N-Acetyl L-Cysteine—along with an oil-in-water emulsion (Alpha-Lipoic Acid, CoQ10, MCT oil).
- Validated Branched-Chain Amino Acids (BCAA 2:1:1), and Alpha-Keto Analogues Tablets, meeting 6-month accelerated stability targets.
- Manage excipient vendor qualification and coordinate with QA/QC, Regulatory Affairs, and Production teams to keep project milestones on schedule.
Manager – Formulation & Development (FR&D)
Micro Labs Limited
Mumbai, Maharashtra
06.2021 - 12.2023
- Managed formulation development, QbD execution, and formula development and stability for 7 solid oral generics across US, EU, and UK markets, achieving 4 bioequivalence (BE) clearances and 3 regulatory filings.
- Led formulation, BE clearance, and Para IV regulatory filing for an Anticonvulsant Extended-Release (ER) Capsule for the US market.
- Completed formulation optimization, BE clearance, and dossier filings for an Antidepressant Immediate-Release (IR) Tablet (US & EU), Antihypertensive IR Tablet (EU), Pulmonary Arterial Hypertension IR Tablet (EU), and Antipsychotic IR Tablet (UK).
- Secured BE clearance for a Proton Pump Inhibitor (PPI) Delayed-Release (DR) Granule and a Skeletal Muscle Relaxant / Antispastic Oral Granule (US), and completed full formulation development for a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) Antidepressant DR Capsule (US).
Senior Researcher – Formulation & Development (FR&D)
Cosci Med-Tech Co., Ltd.
Harbin
09.2019 - 06.2021
- Led generic solid oral formulation development and process optimization for 4 modified-release and granular products targeting the US market.
- Completed formulation development, pre-formulation studies, and ICH stability testing for Antidepressant Extended-Release (ER) Tablet, Antipsychotic ER Tablet, Proton Pump Inhibitor (PPI) Delayed-Release (DR) Capsule, and Second-Generation Antihistamine Oral Granules for the US market.
- Prepared technical development reports and worked with analytical and regulatory teams to ready dossiers for US submission.
Manager / Research Scientist (M1) – Formulation & Development (FR&D)
Lupin Limited
Pune, Maharashtra
08.2013 - 08.2019
- Oversaw end-to-end generic development, QbD scale-up, and regulatory submissions for 6 solid oral and liquid products for the US market, securing 3 commercial approvals and 5 regulatory filings.
- Took an Antiprotozoal Oral Suspension (ANDA) and two Nonsteroidal Anti-Inflammatory Drug (NSAID) Immediate-Release Capsules (Para IV) from lab development through pivotal BE clearance, exhibit/validation batches, tech transfer, filing, and US commercial launch.
- Led formulation optimization, pilot BE studies, and Para IV filings for an Anticonvulsant / Restless Legs Syndrome Extended-Release (ER) Tablet and an Antihypertensive (Calcium Channel Blocker) & NSAID Fixed-Dose Combination (FDC) IR Tablet for the US market.
- Executed pre-formulation, process optimization, and pilot BE studies for a Skeletal Muscle Relaxant IR Tablet (US).
Scientist (R1B) / Assistant Manager – Generics FR&D
Dr. Reddy's Laboratories Limited (IPDO)
Hyderabad, Telangana
01.2010 - 08.2013
- Managed formulation design, QbD execution, bioequivalence studies, and exhibit batch tech transfer for US generic and 505(b)(2) solid oral products.
- Developed, tech-transferred (exhibit batches), and commercialized a Broad-Spectrum Antibacterial Immediate-Release (IR) Tablet for the US market (Para IV).
- Established bioequivalence and completed exhibit batch tech transfer for both Para IV and 505(b)(2) formulations of an SNRI Antidepressant Extended-Release (ER) Tablet for the US market.
- Developed and cleared pilot BE studies for an Antiparkinsonian (Monoamine Oxidase Type B Inhibitor) IR Tablet (Para IV) for the US market while managing ICH stability programs and regulatory documentation.
Research Associate – Generics FR&D
IPCA Laboratories Limited
Mumbai, Maharashtra
05.2008 - 01.2010
- Executed literature/patent searches, pre-formulation screening, excipient compatibility studies, and lab-scale trials for US generic solid oral dosage forms.
Industrial Project Trainee
09.2007 - 04.2008
- Formulated a Fixed-Dose Combination (FDC) bilayer tablet of Antimalarial agents for M.Pharm industrial dissertation.
Education
M.Pharm - Industrial Pharmacy
Annamalai University
Chidambaram01-2008
B.Pharm -
University Department of Pharmaceutical Sciences, RTM Nagpur University
01-2004
Skills
- Regulatory Pathways & Dosage Forms: Para IV, ANDA, 505(b)(2), Immediate-Release (IR) & Extended-Release (ER) Tablets/Capsules, OROS (Osmotic) Tablets, Delayed-Release (DR) MUPS & Granules, Multi-Particulate Pellets, Taste-Masked Granules, Oral Suspensions, Nutraceuticals, Co-Processed Excipients
- Formulation & Compliance: Quality by Design (QbD), Pre-Formulation Studies, Literature & Patent Searches, Scale-Up & Technology Transfer (Exhibit/Validation Batches), ICH Stability Programs, Regulatory Documentation (PDR, MPR, Specifications)
- Process Equipment: Tablet Compression Machines, Rapid Mixer Granulators (RMG), Roll Compaction, GPCG / Fluid Bed Dryers, Spray Dryers, Extruder & Spheronizer, Tablet Coating Pans (Ganscoater), Dyno-Mill, High-Pressure Homogenizers
- Solid-State Characterization: Powder Flow & Shear Testing, XRD, DSC, DVS, SEM
- ScienceDirect, PubMed, MS Office (Word, Excel, PowerPoint)
Personal Information
Date of Birth : 1st February 1982
Father’s Name : Ganpat Kale
Nationality : Indian
Marital Status : Married
Hobbies & Interests: Listening to music, reading pharmaceutical and scientific literature, and spending quality time with family.
Languages Known : English, Hindi, Marathi
Current Address : Flat No. 201, Shivalaya, Plot No. 11, 3rd Main Street, Anna Nagar, Velachery, Chennai – 600042, Tamil Nadu, India
Permanent Address : At-Ruyad, Post-Tekepar, Tah-Kuhi, Dist-Nagpur – 441210, Maharashtra, India
Declaration
Declaration:
I hereby declare that the above particulars of information and facts stated are true, correct, and complete to the best of my knowledge and belief.
Yours sincerely,
Place: Chennai
Date: November 17, 2026
(Radheshyam Kale)
Timeline
General Manager – Formulation & Development (FR&D)
Kawman ExAct Ingredients Private Limited
12.2023 - Current
Manager – Formulation & Development (FR&D)
Micro Labs Limited
06.2021 - 12.2023
Senior Researcher – Formulation & Development (FR&D)
Cosci Med-Tech Co., Ltd.
09.2019 - 06.2021
Manager / Research Scientist (M1) – Formulation & Development (FR&D)
Lupin Limited
08.2013 - 08.2019
Scientist (R1B) / Assistant Manager – Generics FR&D
Dr. Reddy's Laboratories Limited (IPDO)
01.2010 - 08.2013
Research Associate – Generics FR&D
IPCA Laboratories Limited
05.2008 - 01.2010
Industrial Project Trainee
09.2007 - 04.2008
M.Pharm - Industrial Pharmacy
Annamalai University
B.Pharm -
University Department of Pharmaceutical Sciences, RTM Nagpur University