The plant is located on plot No. 18 & 19, Zari causeway road, Kachigam, Daman. This facility is located about 5 km away from Vapi railway station & about 179 km from Mumbai.
The plot size is 7602 sq. mtrs, and the construction area is 7335 sq. mtrs. It has dedicated and segregated areas meeting current cGMP requirements for manufacturing of oral dosage forms - Tablets, Capsules & Liquid orals. Adequate areas for storage of Raw materials, Packing materials & Finished products has been provided.
The manufacturing capacity per annum in single shift is 5100 lac Tablets & capsules and 46 lac litres of liquid orals. The facility is WHO GMP and Schedule M GMP certified by the Indian FDA. The facility is also approved by National Drug Authority of Uganda, MOH Sudan, Tanzania, Malawi and Yemen. The Facility is MHRA-UK and USFDA approved and scheduled for other highly regulated agencies MCC-SA and WHO-Geneva.
The plant is located at Lane-3, Phase I, SIDCO complex, Bari Brahmana, Jammu. This facility is about 20 Kms away from the Jammu Airport. The plot size is 53115 sq.mtr and total construction area is 15981 sq. mtrs.
It has dedicated and segregated areas meeting current cGMP requirements for manufacturing of oral dosage forms - Tablets, Capsules & Liquid orals.
Adequate areas for storage of Raw materials, Packing materials & Finished products has been provided. The manufacturing capacity per annum in single shift is 8040 lac Tablets and capsules and 31.80 lac litres of liquid orals.
Tarapur facility is designed for production, processing and control of APIs. It is situated in the chemical zone of the MIDC - Boisar, Tarapur in Thane district of Maharashtra, INDIA.
Total reaction volume |
: |
44.7 KL (Total Reactor Volume) |
Total plot area |
: |
19690 Sq. m. |
Production facility area |
: |
G.F - 1179.6 Sq. M., 1st & 2nd Floor-1038.77 Sq.M. |
Laboratory area |
: |
332.1 Sq. M. |
Warehouse facility |
: |
1609 Sq. M. |
API Manufacturing capability
Multipurpose two manufacturing block with capacity to manufacture small, medium and large volume product.
State of Art Facility having Two independent Modules of Powder Processing Area A & B.
Facility is equipped with Glasslined Reactors and Stainless Steel Reactors to handle acidic/alkaline reactions, capacity ranging from 500liter to 5000liter to cater versatile batch sizes.
Followed by Charcoalization, crystallization, and centrifuge in Powder Processing Area.
Equipments like RCVD, VTD, Blender, Shifter & Jet Mill are available for further Powder Processing.
We have Clean Room Area with Terminal HEPA Filter Complying 100000 class HVAC system.
Multipurpose facility for manufacturing under cGMP.
Two independent modules.
Both modules can take care for multistep synthesis.
Reaction temperatures range -20 to 200 deg C.
Halar coated centrifuges for acidic products.
100% power backup for plant through own generation.
Q.C , Q.A and regulatory team to ensure cGMP compliance.
Full safety system in place.
Medley is poised to actively participate in this growing opportunity of outsourcing and contract manufacturing.
Services:
Generic APIs
Contract Manufacturing
Contract Research
Custom Synthesis
Intermediates Manufacturing
Zero Discharge Effluent treatment plant
Environment protection, safety and Health are integrated right.
So in a world, where environment threats such global warming is becoming threat to mankind we, at Medley Pharmaceuticals feel it is our responsibility and commitment to work for pollution free world.
The Technical and Physical manufacturing capabilities exist with us for the selected APIs and their intermediates. However those products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Medley offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction.
Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.
Medley Pharma Limited (UK Company), a wholly owned subsidiary of Medley Pharmaceuticals Limited (Indian Company) is Liverpool, UK based company having focus on marketing activities in regulated market of United Kingdom. It is established in 2014 and belongs to 40 licenses for generic drugs and also deals in various OTC and specials products.