Ashok Ghadage Email & Phone Number

Hyderabad, Telangana, India

• 505B2 Formulation research and development for the US market involving solutions and suspension dosage forms.
• Contribute to new product ideation by evaluating the technical feasibility, clinical pathway, regulatory pathway and facility requirements for the program.
• Manage and provide technical leadership to the junior formulation scientists working with the team.
• Lay down program timelines and budget for approval from ELT. Help track the program expenses with the help of finance and project management team.
• Coordinate program initiation by arranging licenses, equipment, new product introduction form, instrument, and license requirements.
• Lay down experimental strategy in consultation with delivery captain, execute the plan with the help of team members and update the relevant stakeholder on the conclusions and way forward. Support for provision and.

Hyderabad, Telangana, India

Solid oral formulation development for China market. IR tablet and capsule dosage form development for China. PDR, QbD and Scale up and exhibit and filing related documentation. Delayed release MUPS capsule dosage form development.

Hyderabad, Telangana

Solid oral formulation development for China markets. Special emphasis on potential and oncology molecules. First to file product developments.Amorphous solid dispersions.Delayed release capsules.Immediate release tablets.Immediate release capsules.Product development report preparation.Query response.BENOC documentation.Pre formulation study.RLD reverse.

Ahmedabad, Gujarat, India

1. Worked on the development of delayed release MUPS capsule dosage form for US market. 2. Worked on the development of immediate release granules and tablet dosage form for US market.3. Regulatory query response and document preparation

Ahmedabad

1. Worked on the development of delayed release MUPS capsule dosage form for US market. 2. Worked on the development of immediate release granules and tablet dosage form for US market.3. Regulatory query response and document preparation

Pune

Developed and filed different kind of solid oral dosage forms by application of QbD approch for US markets. Technology worked are as IR tablet/capsule, ER tablet by Matrix and Osmotic drug delivery system, Delayed release Capsule/MUPS ODT, Powder for suspension, SMEDDS. QbD documentation, PDR preparation,MFC, sampling plan, specification design, JOS, Query.

Pune

1. Developed solid oral immediate release tablet dosage form for USA market successfully cleared bio in single attempt, now product is commercial 2. Involved and supported for PDR preparation of immediate release tablet dosage form for US market. (Product is commercial)

Pune

Worked as Research Intern at ADDS ( Advanced Drug Delivery System) team. Involved in development of ANDA and 505B2 NDA for USA markets.

M.Pharmacy, Biopharmaceutics

M-Pharamacy in Biopharmaceutics

Bachelor Of Pharmacy (B.Pharm.)

B-Pharmacy