Modern API and Intermediate Manufacturing facilities, at two separate campuses covering around 15 acres at Derabassi near the city of Chandigarh and 250 KM to the north of New Delhi, namely:
Unit-1: Manufacturing Fine Chemicals and Advanced Intermediates.
Unit-3: EuGMP compliant, US FDA approvable API manufacturing facility.
API MANUFACTURING UNIT
- Approx. 268 KL (100 Reactors)
- 450,000 Square Feet
- 500 Approx.
- Total of 8, Class 10,000 qualified powder process areas.
- Multipurpose plant with separate high pressure vessel block.
- USFDA, WHO Geneva GMP, AFM with PDMA Japan.
Pilot Plant / Kg Scale Facility
- 2 Pilot Plants cGMP compliant.
- 1 Kg Scale facility (Dedicated for HPAPI production).
- Isolator Block : Dedicated to KG scale production of High Potent APIs.
INTERMEDIATE MANUFACTURING UNIT
- 60 KL (26 Reactors)
- 105,000 Square Feet
- 200 Approx.
- Multipurpose cryogenic reactions, high-volume distillation.
- Expertise in nuclear and side chain halogenations.
- New API & Intermediate facility under construction (Total area : 22 acres).
- Proposed capacity : 12-14 manufacturing blocks including high pressure and solvent recovery blocks.
- Underground tankage.
- High Potent API facility.
- Phase-I to go on stream by 2018.
QA and Regulatory
Fully equipped in-house laboratory including:
- Dedicated Microbiological Lab.
- Wide range of sophisticated 21-CFR-Part 11 compliant Analytical Instruments.
- Lab is well equipped to comply to upcoming ICH Q3D requirements of "Elemental Impurities" with In-House "ICPMS".
- 2nd USFDA for Homatropine Methyl Bromide - March 2017 - ZERO 483s.
- WHO (Geneva) GMP Empanelment for Diethyl Carbamazine Citrate.
- EU GMP certified by Danish Medical Agency (2008, 2015), Berlin & Koln.
- MFDS Korea for Dexketoprofen Trometamol.
- AFM registration with Japanese PMDA.
- TGA Australia Empanelment.
Document Availability and Filing Schedule
- Homatropine Methylbromide (EP/BP/USP), USDMF (active), EDMF filed in Greece and Hungary.
- Atropine Sulphate USDMF (active), CEP (approved).
- Atropine Sulphate Ph.Eur. EDMF filed in Portugal Agency INFARMED.
- Dexketoprofen Trometamol (in-house) USDMF filed.
- Celecoxib (EP,USP,In-house), USDMF (active).
- Diethyl Carbamazine Citrate (USP)-USDMF filed and WHO approved.
- Pregablin (in-house), DMF (Pharmathen).
- Homatropine Hydrobromide (EP/USP), EDMF available.
- Ketorolac Tromethamine (USP/EP), EDMF filed in Portugal Agency.
- Levofloxacin Hemihydrate (USP/In-house) EDMF and JPDMF available.
- Alpha Lipoic Acid (DMF).
- Clopidogrel Besylate DMF available (Pharmathen).
- Clopidogrel Bisulphate (Form-I) (In-house), (DMF QIV 2016).
- Clopidogrel Bisulphate (Form-II) (USP/EP), (DMF QIV 2016).
- Febuxostat, TDP available.
- Cycloserine USP EDMF available.
- "Written Confirmation" from DCGI covering ten (10) APIs available.
We will be delighted to work for you and provide you with a quotation for your consideration.
- If you wish to contact our technical specialist or need additional information,Please email us at: firstname.lastname@example.org