CONTACT US... Your Partner on the Path of...making a Healthier Mankind. Follow us. Scan for web.

Transcription

1 CONTACT US... INDIA HEAD OFFICE 430, DLF TOWERS, SHIVAJI MARG NEW DELHI INDIA TEL FAX WEB PLANT-1 E-1223 PHASE-I EXTN. (GHATAL) RIICO INDL. AREA, BHIWADI , RAJASTHAN (INDIA) TEL PLANT-2 A-141, EPIP, INDUSTRIAL AREA NEEMRANA , RAJASTHAN (INDIA) TEL VIETNAM 1ST FLOOR-LTA BUILDING 15DONG DA, WARD2, TAN BINH DIST HO CHI MINH CITH, VIETNAM TEL PHILIPPINES UNIT 10 A5TH AVENUE CORNER, 26TH STREET E SQUARE CRESCENTS PARK WEST BONIFACIO GLOBAL CITY TAGUIG MANILA PHILIPPINES TEL philippines@xllaboratories.com Your Partner on the Path of......making a Healthier Mankind SINGAPORE 10, JALAN BESAR, #10-12 SIM LIM TOWER SINGAPORE TEL singapore@xllaboratories.com Follow us Scan for web. An EU-GMP, PIC/S & WHO-GMP Certified Pharmaceutical Company

2 We are committed to protect the environment, health & safety of our employees, suppliers, customers & the public by conducting our plant operation of manufacturing in a safe & environmentally sustainable manner. Who we are XL Laboratories is an EU GMP, PIC/S, SAUMP Ukraine, WHO-GMP, GLP and HALAL accredited pharmaceutical manufacturing company. XL houses an R&D center (approved by D.S.I.R, Govt. of India) catering to development and validation of analytical procedures & formulation for own use and on contract basis. XL has 2 pharmaceutical manufacturing facilities:- 1. Plant I at Bhiwadi (Rajasthan) for the manufacturing of Tablets, Hard Gelatin Capsules, Oral Liquids & Powder/ Granules in Sachet. 2. Plant II at Neemrana (Rajasthan) for the manufacturing Soft Gelatin Capsules. EU-GMP XL is present in over 30 countries with more than 400 product registrations encompassing over 45 therapeutic segments. SAUMP UKRAINE PIC/S WHO-GMP FDA, PHILIPPINES FMHACA, ETHIOPIA What we Offer Good Laboratory Practice We are offering contract manufacturing & development (analytical & formulation) services for Tablets, Hard & Soft Gelatin Capsules, Oral Liquids and Powder/Granules in Sachet, dossier development and validation batches. FDA, GHANA NAFDAC, NIGERIA IDCP, HALAL 8

3 WORK CULTURE WORK CULTURE At XL Laboratories Pvt. Ltd., validated process and equipments (process validation, cleaning validation & equipment qualification) are used for manufacturing Pharmaceuticals & Nutraceuticals. Entire manufacturing process - starting from dispensing of material to the warehousing of the materials is as per cgmp, under the strict supervision of manufacturing personnel & IPQC&A personnel. We believe in automating our processes to minimize manual handling. Each batch of raw and packing material is inspected by the QC personnel against the predefined specifications. Only the material complying to specifications are used in manufacturing process. Research, innovation and care describe our services and products best. What we do We manufacture a wide range of prescription medicines and over the counter medications. In addition, our offerings also include dietary supplements and phyto pharmaceuticals. With a large portfolio of over 133 molecules in tablets, capsules (soft & hard gelatin), oral liquids and sachets in over 45 therapeutic classes, XL has the capacity to cater to your every need. Our offering extends across Anti-Infective, Cardiovascular, Pain Management, Gastrointestinal, Central Nervous System (CNS), Respiratory, Anti-Fungal, Orthopedics, Nutritionals, Urology and many more.

4 Incorporation Of Xl Laboratories Pvt. Ltd. st 1 Plant for Production of Soft Gelatin Capsules. Awarded WHO-GMP Certification. Introduction of Tablet, Capsule & Oral Liquid Manufacturing Line. Inauguration of 1st Oversesas Office Approved from NAFDAC, Nigeria. Approved from FDA, Ghana Establishment of 2nd Block for Manufacturing of Tablets Hard Gelatin Capsules & Liquid. GLP Certification. Launched Sachets Facility Best Supplier Award by SPC Sri Lanka. Best Supplier Award by SPC Sri Lanka. Approved by MOH of Tajikistan. Commissioning of 3rd Manufacturing Site for Soft Gelatin Capsules. FDA-Philippines Accreditation PIC/S Certification. SAUMP, UKRAINE Certification. FMHACA, ETHIOPIA Certification EU-GMP Certification. OGYEI, HUNGARY Certification EU-GMP Certification. OGYEI, HUNGARY Certification. (Soft Gelatin Capsules) Journey so far

5 Manufacturing Lines at Plant-I Tablets Capsules (Hard Gelatin) Capsules (Soft gelatin) Sachets Oral Liquids Manufacturing Capacties Annual Capacities: 1 Billion Tablets 800 Million Capsules (Hard Gelatin) 150 Million Capsules (Soft gelatin) 30 Million Sachets 150 KL oral Liquids BHIWADI Manufacturing Plant -I

6 Manufacturing Lines at Plant-II Capsules (Soft gelatin) Manufacturing Capacties Annual Capacities: 150 Million Capsules (Soft gelatin) NEEMRANA Manufacturing Plant -II

7 Quality Control Quality Assurance XL has an in-house fully equipped laboratory to carry out analysis of API's, Excipients & Packing Materials by physical, microbiological, instrumental & chemical testing and effective process control. A separate sophisticated Instrument lab is set up at XL having HPLC's, Atomic Absorption Spectrophotometer, FTIR, UV Spectrophotometer, GC with head space and TOC Analyser. Instrument calibration and validation is a routine feature at XL to ensure accurate analysis results. Accelerated & Real Time Stability Studies are undertaken at XL for different climatic zones as per the ICH, Eudralex Vol. 4 & WHO guidelines. Online rejection of faulty blisters by Camera Inspection Systems is an added feature to the packing machines to ensure quality and quantity before delivery. Fully Fledged Quality Control & Microbiological Laborator y support the entire manufacturing process. Quality Control lab is separate from Production Areas Microbiology testing is segregated S e p a r a t e A i r C o n d i t i o n i n g f o r Q C La b & s e p a r a t e A H U f o r Microbiology Section Equipped with ultra modern instruments like HPLC's GC with head s p a c e F T I R, U V S, A A S, T O C & s t a b i l i t y c h a m b e r s Procedures for handling of deviation, change control, OOS, i n c i d e n t r e p o r t i n g, h a n d l i n g o f m a r k e t c o m p l a i n t, product recall Master validation plan is in place Quality Assurance at XL covers all aspects that collectively or individually impact the quality of the product. That is, the sum of organized arrangements that are made with the aim of ensuring pharmaceutical products are of the required quality as per the intended use. A robust & dynamic QA department in XL ensures. Deviation close out & proper devising of accurate corrective and preventative actions Development and implementation of improved quality reporting measures Promote continuous improvement of the quality management system Providing support and advice during cross functional investigations / projects and as required Approving of pre and post execution validation documents Self-inspections and external audits as appropriate Training in all aspects of quality management systems and GMP including procedural updates The generation of product quality reviews The generation of technical agreements and summary of finished product specifications as appropriate Review of all batch related documentation Support and maintaining business continuity management plans and environmental health and safety requirements Self-inspection carried out at regular intervals Regular training is being provided t o a l l t h e p e r s o n s t o u p g r a d e their competency & better out come.

8 BEYOND BOUNDARIES Research & Development XL houses a dedicated research lab for formulation development and optimization. The Research lab is equipped with pilot scale machinery of all production machines. An analytical research lab is attached to research lab for developmental testing / analytical method development and validations. A separate stability study area for formulation research lab is provided. For many years, XL has been putting great emphasis on the development of new formulations and the R&D Department deserves a lot of credit for the fact that XL has become one of the fast growing pharmaceutical manufacturing & exporting companies focusing on new generics. Creative teams from R&D and business development generate innovative concepts and ideas which are aligned to synergies across therapeutic areas and business needs. The focus of R&D is on quality product development, keeping in view safety and efficacy of drugs on target populations. Our capabilities lies in developing innovative, safe, environment-friendly and cost effective global technologies to deliver high quality products.