Facilities

Facilities that ensure quality and efficiency at every step.

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FORMULATIONS

Formulation Manufacturing Facilities

BDR has its own Oral OSD Oncology Formulation Manufacturing Unit which is accredited by EUGMP and many other global bodies. Additionally, BDR has strengthened its manufacturing capabilities by commissioning a sterile production block for General Liquid/Lyophilised injections and Dry Powder injections and also have a general solid dosage block for tablets, capsules and sachet. BDR have also commenced the project for a Dedicated Oncology unit for liquid injections and PFS which will be commissioned by mid-2024.

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All the plants have been audited and approved by almost all the recognised pharmaceutical companies of India to manufacture their portfolio of products for marketing in the local and overseas markets.

BDR Group has manufacturing facilities as under:

  • API’s (Oncology and General API’s)
  • Pellets
  • Oncology Solid Oral Dosage Forms
  • General Solid Dosage Forms
  • General Injectable (in Vials, Ampoules), Lyophilized and Liquid Fill Injections
  • Oncology Injectable Dosage Forms, currently we offer from EU GMP approved CMO, our own site would be ready by mid-2025.

It's How We Live. It's How We Accelerate Human Achievement.

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ACTIVE PHARMACEUTICAL INGREDIENT

API Manufacturing Facilities

GMP compliant accreditation

BDR has its own General and Oncology API Units which are accredited with WHO- GMP, EU-GMP, COFEPARIS, and ANVISA.

Niche segments of API manufacturing

BDR is involved in the niche segments of API manufacturing, focusing on specialised technology. Our plants have the expertise and the technology to handle hydrogenation and other complex reaction based processes, including a solvent recovery plant which gives us the additional advantage in API processing.

Our API manufacturing units meet the cGMP standards and comply with all the statutes of Pollution control and Environment, health and safety parameters.

Our facilities are also technically and professionally competent to handle all the associated and inherent hazards and risks while manufacturing Oncological range of APIs. As a mandatory safeguard and to ensure maximum protection to staff handling oncology products, utmost care is taken to avoid cross-contamination and possible exposure to lead hazards.

A separate Gram-scale manufacturing zone, that handles processing of high potency molecules gives added advantage to the purpose.

Our pellets manufacturing unit at Hyderabad has been expanded to produce 60 MT per month to cater to the global and domestic demand for quality pellets. We at BDR, are working with top formulators across the globe for pellets and have strategically joined hands with key customers who need our support for the same.

our centres

API Manufacturing Facility centres at BDR

BDR Life-Sciences Pvt. Ltd

Padra, Vadodara
  • Oncology API Unit.
  • General API Unit.
  • Impurity Synthesis Lab.
  • Chemical Processing R&D Centre

VIRDEV Intermediates

Palsana, Guajarat.
  • General API Unit.

Magnum Chemi-Gran

Hyderabad, Telangana.
  • Pellets Unit.
VADODARA

BDR Lifesciences

Oncology, General API Manufacturing Unit, Life-Synthesis Lab and R & D Centre.

Plant Location

  • BDR Lifesciences PVT. Ltd. BDR Oncology & General API, R.S.NO.578,579/A, Near Effluent Canal Road, Village: LUNA - 391 440, Ta. Padra, Dist. VADODARA

Regulatory Approvals

  • Both Oncology & General Blocks have WHO GMP certification
  • ANVISA Approved
  • Facility inspection WHO- GMP, EU-GMP (Hungary), Russian GMP (MOH), ANVISA
  • Also have approval of EUDRA-Romania, FDA - Philippines, NPCM, MOH - Malaysia, INVIMA - Columbia Others - Sudan, Thailand, Uganda, Belarus,Kazakhstan

Strong R&D Capabilities

  • 150 plus scientists with 6 PHDs & Postdoc’s
  • Dedicated analytical Lab for Onco API & General API
  • Well equipped Kilo Lab
  • Separate cell for IPR/RA & DQA
  • Sophisticated instruments like UV, NMR, MASS, LC-MS, GC-MS, ICP-MS, PXRD & IR

Plant Capacity

  • General Manufacturing Block: 16.85 KL/day
  • Oncology Manufacturing Block Unit 1: 4.51 KL/day
  • Oncology Manufacturing Block Unit 2: 70 KL/day
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Features – BDRLS @ Padra – Vododara

  • Individual Blocks on “stand alone” basis for Oncology and general products with various kind of equipment i.e. Reactor, Centrifuge, Pressure Nutsche Filter, Sparkler Filter , Rotacone Vacuum Dryer , Vacuum Tray Dryer, Fluid Bed Dryer, Isolator , Jet Mill, Multimill, Blender in existing API facility.
  • Each stage of operation in dedicated areas with individual AHUs to minimize cross contamination
  • Oncology range of products are handled under “Isolators” and with special protective gowns for operators to minimize risk of exposure
  • Includes 2,800 m2 of area dedicated to admin, utilities and EHS utilized by OSD as well as API facilities
  • Exhausts from the manufacturing blocks through wet scrubber system to control environmental pollution
  • High capacity "Treatment Plant" for treating effluents.
  • Equipped with separate Gram-scale manufacturing zone that handles processing of high potency molecules
  • Special solvent recovery plant gives an additional advantage in API processing through recycling and reuse.
  • Solvent Recovery Plant : 3 Solvent recovery systems, each equipped with reactor having 8 KL capacity for recovery of various type of solvents equipped with distillation packed column with structured packing .
  • Solvent recovery systems typically consist of a glass-lined reactor, a glass distillation overhead with heat exchangers, a packed rectification column as well as distillate coolers and receivers.

Supplementary Amenities

  • Isolator : Oncology range of products are handled under “Isolators & Powder transfer system” and with special protective gowns for operators to minimize risk of exposure during sampling, packing and dispensing.
  • Spray drying plant : 25 Kg/hr (cGMP) Solvent Evaporation Capacity at 70°C closed Loop Spray Drying System exist at site for drying of product.
  • Reaction Capabilities :
    • Reduction
    • Nitration
    • Acetylation
    • Hydrolysis
    • Grignard
    • Chlorination
    • Bromination
    • Hydrogenation
VADODARA, GUJARAT

New R&D Centre at Vadodara

Features

  • New World class R&D facility (50000 sft) is under construction at Luna campus having four floors.
  • In include Oncology division, General API division, Peptide Chemistry division, Analytical development Laboratory and Sophisticated Instrumentation laboratory.
  • R&D lab equipped with 60 fuming hoods with 200+ scientist (M.Sc., M. Pharm, PhD, Postdoc), with highly advanced equipment's.
  • Separate cell for Intellectual Property Rights (IPR), Regulatory Affairs (RA) and Developmental Quality Assurance (DQA)
  • Sophisticated Instrumentation laboratory includes UV, NMR, MASS, LC-MS, GC-MS, ICP-MS, PXRD and IR
  • Centralized Impurity Cell (Synthesis of impurities, column purification, characterization & Qualification)
  • Process excellence and Process safety lab.
PALSANA, SURAT

VIRDEV Intermediates

General API Unit.

Plant Location

  • Block No. 46-47, Plot No. 02, Moje Taluka: Palsana, Guajarat 394315.

Regulatory/Plant Approval

  • WHO GMP Certification & EU GMP

Plant Capacity

  • Current 110 KL
  • Post Expansion180 KL

Products Patents

  • US Patent for Etoricoxib No. US 8,841,457 B1
  • Filed Indian and PCT applications for Linezolid
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Features

  • Fraction Column for Solvent Recovery:
    • Capability to fractionate solvent mixtures
    • Effective Yield and Cost efficiency
    • 4 KL and 5 KL distillation units with structured packing columns
  • Hydrogenation Process : Four S.S. Reactors of capacity 2 Nos 0.275 lit , 1 KL and 2.5 KL- 25 Kg/cm2 pressure
  • INDUSTRIAL SIZE CHROMATOGRAPHIC COLUMNS :
    • Industrial capacity chromatographic columns (2-3 feet diameter, 10-15
    • Feet height, capacity to pack approximately 800-1000 kg adsorbents)
    • Zone that handles processing of high potency molecule
    • LYPHOLIZER :- 19 lit & 75 Lit Capacity
  • Expertise and capability to handle following Reaction Processes:
    • FRIEDAL-CRAFTS REACTION
    • OXIDATION
    • BROMINATION / CHLORINATION / IODINATION
    • CRYOGENIC REACTION
    • CONDENSATIONS
    • CHIRAL-RESOLUTION
    • AMINATION
    • GRIGNARD REACTION
    • METHYLATION
    • REDUCTION
    • NITRATION
    • ACETYLATION
    • N-BUTYL LITHIUM REACTION
    • SODIUM-HYDRIDE REACTION
    • POTASSIUM TERTIARY BUTOXIDE REACTION
    • PRESSURE REACTIONS / HTDROGENATION
    • CHROMATOGRAPHIC SEPARATION
    • WITTING REACTION
    • DEBENZYLATION
  • Lab Instruments
    • HPLC – 20 Nos
    • GCHS – 04 Nos
    • Preparative HPLC for Impurity Separations
HYDERABAD

Magnum Chemi-Gran

Pellets Unit – having capacity of 60 MT/month, post recent expansion

Plant Location

  • Plot No. 163/D, Phase II, Cherlapally, Kapra Municipality, Ghatkesar Mandal, R.R. District, Hyderabad - 500 051.

Regulatory Approvals

  • GMP Approved
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Features @ Magnum Chemi-Gran

  • Granules/Pellets manufacturing capabilities
  • 4 different dedicated processing areas
  • F&D capabalities tanging from 60kgs to 300 kgs
  • Dedicated HVAC system to minimize cross contamination
  • Appropriate pressure gradiation/zoning maintained
  • GMP compliant warehousing with segregation for RM/PM?FG of finished goods
  • Fully equipped QC lab for in-house testing and release of all input materials and finished goods
  • Small R&D lab to address developmental & scale up batches
FORMULATIONS

Formulation Manufacturing Facilities

BDR operates an Oral Oncology Formulation Unit accredited by EUGMP and various other international bodies. We have further enhanced our manufacturing capabilities by establishing a sterile production block for General Lyophilisation, Liquid Injection, and Dry Powder Injections. Additionally, we have a general solid dosage block for tablets, capsules, and sachets. We have also initiated a project for a Dedicated Oncology unit focused on liquid injections and pre-filled syringes, expected to be operational by mid-2024.

Plant Location

  • Plant 1: RS No 578, Near Effluent Canal, Luna, Padra, Vadodara
  • Plant 2: Survey No. – 51/1/1, 51/1/2…52/5,53/1,53/2..54/2, At – Vanseti Village, Po – Tajpura, Taluka-Halol, Dist. Panchmahal – 389 350, Gujarat

Formulation Facilities Of BDR Group

  • Oncology Oral Solid Dosage Unit based in Plant no. 1 at Padra Gujarat
  • General Injectable Unit based in Plant no. 2 at Halol, Gujarat
  • General Tabley, Capsule and Sachet Unit based in Plant no. 2 at Halol, Gujarat
  • Oncology Injectable Unit (Upcoming) based in Plant no. 2 at Halal, Gujarat

Regulatory Approvals

  • EU-GMP
  • WHO-GMP
  • Anvisa
  • Kenya-PPB
  • Belarus GMP
  • Nigeria - NAFDAC
  • PICS’s Philippines
  • Ukraine
  • Malaysia
  • Invima
  • Thailand - FDA
  • Uganda – NDA
  • Sudan – NMPB
  • Yemen - SBDMA
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All the plants have been audited and approved by almost all the recognized pharmaceutical companies of India to manufacture their portfolio of products for marketing in the local and overseas markets.

Features Of Onco OSD Manufacturing Block At Padra –Vadodara

  • Dedicated “stand alone” block for Oncology.
  • Each stage of operation in dedicated areas with individual AHUs to minimize cross contamination.
  • Dedicated capacities for Coated/Uncoated tablets and capsules in Blisters.
  • Oncology range of products are handled under “Isolators” and with special protective gowns for operators to minimize risk of exposure.
  • Triple-layer security: Product vs. Human exposure.
  • Best-in-class quality compliance demonstrated by negligible rejection rate.
GUJARAT

BDR Pharmaceuticals International Pvt. Ltd.

General Injectable, General Solid Dosage - Tablet, Capsule and Sachet Unit.

Plant Location

  • Survey No. – 51/1/1, 51/1/2, 51/2, 52/1, 52/2/1, 52/2/2, 52/2/2 (P), 52/4, 52/5, 53/1, 53/2, 53/3, 54/1, 54/2, At – Vanseti Village, Po - Tajpura, Taluka – Halol, Dist. Panchmahal – 389 350. Gujarat.

Regulatory Approvals

  • EU GMP Approved
  • WHO GMP Approved

Plant Area Distribution

  • General Oral Solid Area 8475 m2
  • General Injectable Area11295 m2
  • Expansion plan
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Features Of BDR Pharma – Halol unit

  • Oncology Injectable
    • 200 vials/min
    • 2 Nos, each having 30k of 10ml per load capacity - Lyophilizer
  • General Injectable
    • 300 Ampoules/min
    • 250 vials/min
    • 2 nos, Each having 54k of 10ml per load capacity Lyophilizer
    • Vials size:- 2 ml - 50 ml
    • Ampoules size:- 1ml - 30ml
    • DPI having capacity of 120-240 vials per minute
  • Solid Oral
    • 3 granulation suites – 60, 150, 300 kgs
    • Packing - Blisters, Sachets , Strips and Bottles
    • Annual Capsule Capacity - 300 Million
    • Annual tablet capacity - 1.2 Billion
  • General block – Expansion Plan
    • 3 modules of 1500 kgs each per lot - Ointments and creams
    • 3 modules of 600 kgs each per lot – Pellets and MUPS
GUJARAT

Oncology Injectable Unit (Up-Coming)

Plant Location

  • Halol, Gujarat.

Features

  • Vial line - Capabilities & equipment
  • Liquid vial filling line having an output of 120-150 vials per min, with online Lyophilisers(2 Nos).
  • Each lyophiliser is having a capacity of 30,000 vials of 10 ml per load, annexed with ALUs.
  • Isolator protection at ALL critical stages, protecting the exposure of the product & personnel handling the operations.
  • Separate aseptic manufacturing area duly synchronised within the block for manufacture of complex molecules.
  • Capabilities of 100% leak test & visual inspection built in.
  • The entire line is housed within classified areas, meeting the cGMP standards.
  • All equipment handling these operations will be CFR21 compliant.
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