Prasad Guggilam
Formulation Scientist
- Role
- Formulation Scientist at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Prasad Guggilam
Working as a Research Scientist - Formulation R&D
Experience
Formulation Scientist
Dec 2024 — Present
Responsible for development of generic solid dosage forms for US markets as per time lines.Responsible for performing the process operations during formulation development studies as per SOP\'S and Guidelines.Responsible for conducting Pre formulation & Stability studies.Ensuring the license in place from local FDA related to test, manufacturing, import and Bioequivalence No Objection certificate.Review of Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), Pre/Process validation protocol, packaging validation protocol, Hold time study protocol, In-use stability protocol, Cleaning verification protocol, Splitability study protocol, Polymorphic study protocol, Photostability protocol & Thermal excursion study protocol related to ANDA/ Submission batches.Deciding the API quantity required for complete development cycle from prototype to exhibit batch.Finalizing the in process, finished product and stability testing specifications.Literature review and deciding on the non-infringement composition and process.Deciding the Reference Listed Drug Product (RLD) Quantity required for development, pilot /pivotal bioequivalence study & bio retention.Selecting the excipients based on reference/ marketed product & FDA\'s inactive Ingredient Database (IID).Formula and process optimization by QbD approach.
Skills
- Validation
- Pharmaceutics
- Drug Discovery
- Web Browsing
- Hplc
- Regulatory Submissions
- Regulatory Affairs
- Pharmacology
- Chromatography
- Anda
- Pharmaceutical Industry
- Sop
- Glp
- Ms-Office
- Gmp
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.