Products

With our world-wide presence and integrated manufacturing operations we are well positioned to cater to the growing demands, across all our businesses. We aim to move up the value chain through vertical integration in Healthcare (R&D to manufacturing of API / FDF / brands) and target niche opportunities in the Specialty Chemicals segment

API

Our Active Pharma Ingredient (API) business is driven by our subsidiary Uquifa. Uquifa, based in Barcelona Spain, manufactures Active Pharmaceutical Ingredients (APIs) and intermediates for the global market. Our portfolio of product(s) includes 150+ active DMF´s and 20 approved COS. We continue to invest in personnel and facilities to maintain a strong technology offering, to both, the Generic Industry and the Ethical Pharmaceutical Industry.

Vivimed is the partner of choice for large global players in various therapeutic segments such as anti-ulcer, anti-depressants, oncology, anti-diabetics and others.

Manufacturing Facilities

We operate 3 manufacturing sites- 2 in Spain and 1 in Mexico, which operate under cGMP conditions and have been inspected and approved by major Pharmaceutical Companies and Regulatory Authorities, including the US FDA.

Location Key Parameters
Llica Barcelona, Spain 29 reactors (10 glass-line, 17 stainless steel)

·         Total capacity of 140 m3

·         Extensive material handling capabilities allows efficient production of bulk API

·         Last FDA Inspection date: July 2012

·         Last EDQM Inspection date: August 2013

·         ISO 14001:2004 certified

·         Inspections and approvals by Spain and Japanese health authorities

Sant Celoni Barcelona, Spain 29 reactors (15 glass-line, 14 stainless steel)

·         Total capacity of 120 m3

·         Last FDA Inspection date: July 2012

·         Last EDQM Inspection date: August 2013

·         ISO 14001:2004 certified

·         Inspections and approvals by health authorities from EDQM, ANVISA (Brazil), Japan, Korea and U.S.

Cuernavaca Mexico ·         Low cost – high capability

·         30 reactors (16 glass-line, 14 stainless steel)

·         Total capacity of 150 m3

·         Last FDA Inspection date: 2013

·         EDQM Inspection date: August 2013

·         Inspections and approvals by health authorities from Denmark, Japan and Korea

Finished Dosage Formulations (FDF)

Leveraging our streamlined operations from R & D to manufacturing, we have crafted a value-add model that effectively transitions from APIs to various formulations and new drug delivery systems.

Our outstanding 7 manufacturing facilities, stringent quality standards, robust compliance practices and an enviable regulatory track record combine to make our Finished Dosage business, a true value-based solution. Be it sterile or solid dosage forms or specialist filling, we accelerate the speed-to-market for our customers while mitigating risk.
We have initiated several strategic initiatives to strengthen and fortify our FDF business across generic, branded and contract manufacturing segments.

In a short span we expanded our MRs from 40 to 100, achieved 30 market authorizations and ANDA’s and have set-up a contract research lab to support our own filings of MA and ANDA.

Having established ourselves with finished formulations in the semi regulated markets, we set our sights on growth in the regulated generic markets such as Europe, US, Canada & Australia.

Regulated Markets

With the acquisition of the US FDA approved solid oral dosage (SOD) facility at Alathur, Tamilnadu, from Actavis in 2013 we are now ready to deliver quality generic formulations to the regulated market. Our facility at Alathur, Tamilnadu, India is dedicated to solid dosage form manufacturing, supported by an outstanding regulatory record and intimate knowledge of what the FDA and other regulators expect. We cover everything from blending, granulation, compression, encapsulation, coating, drying and formulation to packaging – would this statement be true, for Alathur?

Manufacturing facility

Located on an expansive area of 20,000 sq. Mts, this facility is equipped with state-of- art machinery. With a current installed capacity of 1.2billion Solid Oral Dosage (SOD) (Capsules 500 Milo Units; Tablets: 700 Milo Units), plans are underway to enhance this capacity to 2 billion SOD.

Key features

  • Can handle 12 product transfers per year
  • Packaging capacity : 300 Milo Units
  • Warehouse equipped with
    • 1099 pallets space for RM and PM
    • 80 pallet space for FP
  • Dedicated mfg. areas for product transfers & commercials
  • 100% check weigher for filled capsules
  • Tablet press with auto-weight control
  • Integrated bottle packaging line with tertiary 1D barcode

Regulatory History

  • US FDA inspected in April 2007, PAI for Metformin HCl and declared as acceptable
  • US FDA inspected in April 2009, PAI for Lovastatin Tablets and declared as acceptable
  • US FDA inspected in April 2011, PAI for Gabapentin Capsules and declared as acceptable
  • US FDA inspected in September 2013 and declared as acceptable
  • Certified for ISO 14001: 2004 Compliance
  • Certified for OHSAS 18001: 2007 Compliance

Products

Approved Products:

  • Losartan Potassium Tablets 25, 50 and 100 mg
  • Donepezil HCl Tablets 5 and 10 mg
  • Amlodipine Besylate Tablets 2.5, 5 and 10 mg
  • Zolpidem Tartrate Tablets 5 and 10 mg
  • Metronidazole Tablets 250 and 500 mg

Products Under Development:

  • Cinacalcet Tablets 30, 60 and 90 mg
  • Ranitidine Tablets 75 and 150 mg
  • Albendazole Tablets 200 mg
  • Valacyclovir Tablets 500 and 1,000 mg

Manufacturing Facility

Vivimed’s has established 6 manufacturing facilities- 3 at Hyderabad, 2 at Uttarakhand and 1 at West Bengal, are all WHOGMP certified. This reflects Vivmed’s commitment towards quality and safety.