about State-of-the-Art World Class Manufacturing Flagship Injectable Plant [iy Dundigal Hyderabad » Vials: 250 mil units/year » Ampoules: 150 mil unitsiyear » PES: 40 mil unitsiyear » Lye Vials: 30 mil units/year » Bags: 30 mil unitsiyear » Ophthalmics: 60 mil units/year 12 Manufacturing Lines » 6 Vial Lines with 8 Lyophilizers (1 - 100 m) » 2 Ampaule Lines (1 - 10 m\) » 2 PFS Lines (0.5 -6 mi) » 1 Bag Filing Line (Fill volume 80 - 500 mi) » 1 Ophthalmic Line Penems Plant Pashamiylaram, Hyderabad Oncology Plant Visakhapatnam 2 Manufacturing Lines » 1.4 mil unitsiyear » Lyo Vials - 8 mie » Lyo Vials - 5 miyear » 2 Lines with 3 Lyophilzers (2 - 100 mi) » Filling at 5°C temperature » 1 Vial Line - Powder Filling (2-100 ml) » CRABS in Grade-B erea » 1 Vial Line with 2 Lyophilzers (2-100 mi) » Manufacture of products sensive 08S liners Pashamylaram Plant Pasharylaram, Hyderabad » Vials: 200 milyear » PFS: 100 miliear » Lyo Vials: 50 milyear » Ampoules: 100 milyear 8 Injectable Manufacturing Lines » 2 Vial Lines (2 - 100 mi » 2Vial Lines with B Lyophilzers (2 - 100 mi » 2PFS Lines (0.5 - 10 mi) » 2 Ampaule LinesHighlights Leading Injectable manufacturer with in-house API development & manufacturing facilities Danone va Indian Company to set up a State-of-the-Art facility for Pre-filled Syringes (PFS) SUC corel cc aa Waay() Sao Seu ea UU ame a ar Deets | OTT Vertically integrated One-Stop Shop Active Pharmaceutical Ingredients - APIs Development » Synthetic Chemistry » Analytical Chemisty Manufacture » API scale up » Multiple Suites n various Batch Sizes » API facilities approved by EDOM & US FDA Finished Product Development » Formulation development * Analytical development » Method development » Packaging development Manufacture » Finished product manufacturing » Quality Control & Quality Assurance » Packaging » Warehousing » Shipping & LogisticsQuality Control & Quality Assurance © Quality Tec OU et acur ke meric eta + Well-equipped in-house Quality Lab asic ecm D\-\=1e) e008 Tone) attest a acme ea? eee aae mia aTeIAle] + Pilot and scale up stu CELE) * Formulation develo} Peete ee ello Or eroe eee Use a) Pe) OP Ne athe uae Ro Sor Nee Camo Me Rance) rimary reference standard preparation andServices Contract Manufacturing de} PANES PaRORV Ely Dr eet ec} ANAL ter > Ophthalmics leone lesion ome eB oncne » Synthetic Chemistry > Formulation Development » Analytical Methods and Validations Pes eas eS Out-licensing of Products eee cen ence Dea emcee cd LacrelU LON © Experienced in generic CTD/eCTD regulatory filings Other Services ® Clinical Batch Manufacturing“Global Generic Injectable Player providing total solutions ” Manufacturing “Facilities” approved by FDA SaaS MHRA - UK Tae cig WHO - Geneva TGA a ste Countries BGV Reet Couey) a 3} a - Czech Republic (EU) continents ENVIS, aasicy AN Seo 3 Sao BENT NAFDAC SN orciey NDA Uganda PPB cone & GLAND PHARMA LIMITED Regd, Office: 6-3-865/1/2 Greenland Apts., Ameerpet, Hyderabad - 500 016, India Soe ta ea eee eee ere Sree ae