VIJAYABHANU PRATTIPTI
Hyderabad, AP (IND)
Role(s):
Founder/Owner/Principal
PLEIADES THERAPEUTICS PRIVATE LIMITED
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Startup
Location:
HYDERABAD
Industry:
Pharmaceuticals
Year Founded:
2020
Number Employees:
10-50 people
Business Stage:
Growth (profitable)
Entity Type:
Incorporated Outside United States
Description:
Pleiades Therapeutics Private Limited established in year 2020, R&D centre located in IDA Jeedimetla, Hyderabad, Telangana, India. Pleiades provides contract product development services /Contract Analytical Testing for pharmaceutical organizations across the globe for regulated market filings. We are in the CDO & CTL services business from last 3 years for US, EU and Asia Pacific clients.
Pleiades Therapeutics operates at an 8,000 sq. ft. R&D facility with highly qualified and experienced team of pharmaceutical formulation scientists, analytical chemists and compliance specialists in regulatory affairs and pharmaceutical product development and knowledge transfer. The R&D centre is fully equipped with state-of-the-art equipment used in pharmaceutical product development and analytical method development and validation process. Our lab is 21 CFR Compliant and its operations are set up to meet cGMP requirements.
Founder/Owner/Principal
PLEIADES THERAPEUTICS PRIVATE LIMITED
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Service Provider
Location:
HYDERABAD
Description:
Company Profile:
Pleiades Therapeutics Private Limited established in year 2020, R&D centre located in IDA Jeedimetla, Hyderabad, Telangana, India. Pleiades provides contract product development services /Contract Analytical Testing for pharmaceutical organizations across the globe for regulated market filings. We are in the CDO & CTL services business from last 3 years for US, EU and Asia Pacific clients.
Core competency of the team includes formulation development, process optimization, analytical method development and validation of various dosage forms in oral solids, oral liquids, sterile liquid and semi-solid product category.
For generic market, we have our own assets (ready tec packs) in various therapeutic areas like, anticoagulants, antidiabetic, oncology and critical care medicines. Some of our inhouse products are ready for pilot BE studies/knowledge transfer through scaleup/engineering batches at client defined manufacturing sites or Pleiades Therapeutics exclusive CMO’s through product out-licensing/in-licensing.
Our development house will provide a complete one-stop solution for product development as well as customized services as per the customer need.
Product Development Services Includes
Formulation & process development and optimization studies up to pilot scale/ engineering batches
Oral drug delivery systems (Solid orals, liquids and suspensions…etc.)
Topical dosage forms: Ointments, creams, gels and lotions etc.
Injectables (Liquids/suspensions)
RLD characterization studies – Q1/Q2/Q3
Preformulation studies include Intrinsic solubility, drug-excipient interaction studies, excipient screen studies etc.
Pre-clinical batch for PK studies like In-Vivo DMPK studies (small animal studies)
Pilot/bio-batch manufacture (Clinical testing)
Submission batch manufacturing support
CMC documentation and regulatory filing support
Standalone Analytical Services Includes
API characterization and solubility studies.
Finished product method development, partial validation, and transfer.
Specifications development
Stability studies as per ICH guidelines
Photostability studies
Analytical methods for cleaning verification and validation
Forced degradation studies and stability indicating method development.
Innovator Product Characterization
Reverse engineering studies of the innovator product
Pharmaceutical equivalence studies/multimedia dissolution Profile studies.
Accreditations: ISO 9001:2015, ISO 14001:2015 and ISO 45001: 2018.
Approved by local drug regulatory authority - Telangana Drug Control Department
R&D Employees: Total of 16 scientists working various departments: F&D - 5, AR&D - 10 and DQA- 1 and Admin - 1
Services Provided:
- Business Consulting
- Patent Idea or Invention