[vc_row el_class=”service-sec service-sec-tab “][vc_column][vc_text_separator title=”Pharmaceutical Development” color=”vista_blue” style=”double” el_class=”als-sprt”][vc_tta_tabs color=”vista-blue” alignment=”center” active_section=”1″][vc_tta_section title=”R&D infrastructure” tab_id=”1616052225467-0c750369-c269″][vc_column_text]

1. Oral liquids and solid dosage forms
2. Injectable formulations
3. Semisolids and pastes
4. Topical pour-ons and spot-ons

[/vc_column_text][/vc_tta_section][vc_tta_section title=”Specialized capability” tab_id=”1616052225474-2f996591-d15c”][vc_column_text]

1. Veterinary boluses
2. Modified release dosage forms
3. Stable multivitamin injectables and oral formulations & nutritional supplements
4. Premixes and feed additives
5. Palatable dosage forms including chewable tablets, compressed soft chews, oral pastes and suspensions
6. Taste masking, coating & stabilization of sensitive APIs

[/vc_column_text][/vc_tta_section][vc_tta_section title=”Technical capability” tab_id=”1616052353270-90479785-e4b9″][vc_column_text]

1. A combined formulation development experience of 40 + years including human and veterinary products development for regulated, emerging and India markets in both generic and innovator space.
2. Analytical team with combined experience of 40 years with a plan to expland the team further to cater to growing demands of regulated market development
3. DQA team of 20 + years experience to ensure that a culture of quality is inherent in the entire product development process
4. Regulatory team with experience in both regulated and emerging markets experience In house IP expert
5. Project management team for efficient running of in-house and client based projects and ensuring timely completion and deliverables

[/vc_column_text][/vc_tta_section][vc_tta_section title=”Equipment capability” tab_id=”1616052451677-3bb9f6dd-07e2″][vc_column_text]The R&D is designed to cover all major dosage form development. We understand the importance of balancing cost of product development while not compromising in the product quality. Our labs have thus been designed and equipped to handle small lab batches to support proof of concept studies, prototype and lead formulation development and scale up studies.

Well equippedoral solid development lab

• High shear mixer granulator, octagonal blender, multimill, fluidized bed processor and compression machines
• Batch size capability: 0.5 kg up to 10 kg.
• Fluidized bed processor with top spray and bottom spray Wurster coater. Processes can be scaled up to 5 kg (finalized)
• Compression machines to handle development of a wide range of tablet sizes right from 6 mm up to large boluses of 6 cm to cover the entire spectrum of human and veterinary requirement

Dedicated injectable development facility

• Cleanroom (class 100000/ Class 5) for preparation & compounding
• Class 100 laminar flow area for aseptic processes
• Dry Heat Sterilizer (DHS) for sterilization of vials & manufacturing vessels
• Terminal sterilizer for finished product sterilization

Liquid dosage form lab

• Portable Jacketed manufacturing vessel to enable scale batches up to 30 L for liquid formulations to identify and address any process challenges early on in the R&D.

[/vc_column_text][/vc_tta_section][vc_tta_section title=”Testing and Characterization Lab” tab_id=”1616052666094-ec846de6-c762″][vc_column_text]Analytical instrumentation

• HPLCs
• Shimadzu and Waters, LC solution and Empower software, UV and PDA detectors
• Gas chromatography
• Dissolution apparatus
  1. 6 stations with 4L dissolution bowls specifically used for testing boluses
  2. 12 stations for conventional tablet testing

Instrumentation for drug product testing and characterization

• Viscometer, pH meter, dissolved oxygen analyzer
• IPQC instrumentation include tablet hardness and dimensions tester, disintegration tester, friability tester.

Packaging equipment & instrumentation

• Blister pack machine
• Manual vial crimper
• Vacuum leak tester

Stability studies to support product development run in-house

• ICH conditions including 40°C/75%RH, 25°C/60%RH, 30°C/65%RH
• Photostability chamber

[/vc_column_text][/vc_tta_section][/vc_tta_tabs][/vc_column][/vc_row][vc_row css=”.vc_custom_1616053799946{margin-top: 40px !important;}”][vc_column][vc_text_separator title=”Contract Manufacturing” color=”vista_blue” style=”double” el_class=”als-sprt”][vc_row_inner][vc_column_inner width=”1/2″][vc_column_text]FEES FOR SERVICE-(FFS):

Client agrees to a project cost under the agreed scope of work and the project cost is split into milestones which gets paid on achievement of the deliverables attached to the milestones.

The project is deemed complete after successful technology transfer of the product to the clients manufacturing site and/or successful Bio Equivalence.

Client compiles and les the dossier to the regulatory agencies.[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/2″][vc_column_text]TURNKEY:

Financial Contribution to the Project by Ashish lifescience.

Prots split after launch of Product in the ratio of investment.

Backward integrated projects with API of interest in this model and complete dossier management.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]