Documenti di Didattica
Documenti di Professioni
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to New Zealand
26thHIGH
July AUCKLAND
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www.inzbc.org
AXA PARENTERALS LIMITED
Company Profile:
AXA Parenterals Limited is manufacturing Intravenous Fluids in Polyethylene containers under
aseptic conditions using the latest “State-Of-The-Art” AFFS Technology. The plant has been
designed as per USFDA and EU regulatory guidelines.
The facility has been incorporated in Year 2006, and commercial production started in 2007.
The Company is equipped with “Form-Fill-Seal” plant and machineries. LVP and SVP machine
obtained from Rommelag, Germany, global leaders in this technology. The containers are
blown and filled with the I.V. Fluid and sealed in closed circuit in most aseptic condition, which is
totally automatic and devoid of any human touch. The aseptically sealed bottles are further
sterilized in Sophisticated Superheated Sterilizer.
Product profile:
Axa offers its products Large Volumes Parenterals (1000 ml, 500 ml, 540 ml, 450 ml, 350 ml,
250 ml, and 100 ml) and Small Volume Parenterals (10 ml, 8 ml, 5 ml, 3 ml, 2 ml, and 1 ml).
Large Volume Parenterals (Ringer Lactate, Dextrose, Sodium Chloride, Metronidazole,
Ciprofloxacin, Levofloxacin) having HSN 3004
Small Volume Parenterals (Ophthalmic preparations 0.5 ml -15 ml, Respiratory Respules 2ml-5
ml) having HSN 3004
BRASSICA PHARMA PVT. LTD
Designation:
CEO
Office Address 701-702, Vastubh Apartment, Off Road to Carter Road No. 1,
Dattapada, Borivali East,
City
Mumbai 400066 Maharashtra
Mobile Number:
91-9820022724
E-mail:
deepali@brassicapharma.com
Website:
www.brassicapharma.com
Company Profile: Brassica Pharma Pvt. Ltd A State-Of-The-Art Contract Research And
Manufacturing Organisation (CRMO), With ‘Sterile Manufacturing’ As Its Core Competence. It Is
One of The Few CRMO’s In Asia with A ‘Sterile Facility’ Of EU Standards In The Sterile Gels,
Ointment And Pre-Filled Syringes Dosage Forms.
Development Capabilities
• Development of More Than 50 Products for Indian Market and Row Market .Developed
Sterilization Methods For Various Api And Finished Products In Creams, Gels And
Ointment Dosage.
• Ce –Certification Of Medical Devices In Ophthalmic Range For Uk And Usa
Market.Product Registered In Usa
• Development Of Unique Delivery Systems For Ophthalmic Mists And Also Development
Of Dosages For Hybrid Registrations
Manufacturing Capabilities
• Designed As Per Eu Norms With Best In Class Machinery From Italy One-Of-A-Kind
Facility In Entire Asia
• Passed Sqa Inc., Usa Audit On Behalf Of Multinational Company Allergan, Pioneers In
Ophthalmic
• Aseptic Manufacturing & Filling Of Ointments And Gels Of Batch Size 500 Kgs. (3 Million
Tubes/Year) & Filling Of Prefilled Syringes Of Batch Size 100 Kgs (7.5 Million
Syringes/Year)
Product profile:
CAREMAX FORMULATIONS
Year of Establishment:
No. of manufacturing plants: 2
Details of Quality Accreditations: WHO-GMP
Product Category: Formulation
[Diabetology,CNS,Immunology,CVS,Metabolic
Disorder,Respiratory,Vitamins/Minerals,Dermatology]
Company Profile:
We are one of the significant players in the Indian pharmaceutical market and thus, we ensure
innovative, high quality and affordable solutions in medicine. With the establishment of the
company in 19 86 we started our long journey in the sector. The manufacturing facility was
established in 19 and has been continuously upgraded to meet modern manufacturing norms.
Currently we have a state of the art facility located in the heart of the city. We are equipped with
modern machines.. We have a separate Beta Lactum and non Beta Lactum section which
conform to gmp standards. All aspects of the production are documented as per standards.
Product profile:
We have separate dedicated teams for quality control and quality assurance comprising of
highly qualified and experienced professionals. Our laboratory is also approved by the drugs
control department, government of India for commercial testing of products of other companies
as well. We have a large product range including several dcgi approved molecules and
combinations. These products are available in various dosage forms such as tablets, capsules,
soft gelatin capsules, oral powder for suspension and injectable preparations covering various
therapeutic areas.
ECOBLISS INDIA PRIVATE LIMITED
Year of Establishment:
Company Profile:
Ecobliss, a global leader in blister and high visibility packaging solutions, is well known for
innovative packaging solutions in field of Pharma/Healthcare Packaging, Food, Electrical and
Electronics, Toys, Stationery etc.,Our packaging solutions include:
• Cold Seal & Heat Seal Blister Packaging
• Tamper Evident Packaging
• Clamshell Blister Packs
• PET & PVC Blisters
• Pharmaceutical Wallets
• Dose Packs
• Promotional Packs
• Packaging Design & Development
• Folding Cartons
• Physician Samples
• Child Resistant Packaging
• Fluted Cartons
• Sealing Equipment
• Transparent Boxes
Winner of several International/National awards for packaging excellency like WPO Worldstar
awards, Worldstar President’s award, Ameri-star award, Indiastar awards etc.,
HEALTHCAPS INDIA LIMITED
WHO-GMP,USFDA,
Details of Quality Accreditations:
Company Profile:
Healthcaps India Ltd. was incorporated in 1983 to cater to the ever increasing demand of the
pharmaceutical industry for hi- quality empty hard gelatin & hpmc capsules. With the objective of
creating an environmental, eco-friendly and a state of the art manufacturing facility with stringent
quality control checks in place we chose the open spaces in Fatehpur, Punjab, 60 kms from
Chandigarh. And to facilitate easy interaction with clients, we have established offices in
Chandigarh, New Delhi and Mumbai.
Product profile:
EMPTY HARD GELATIN CAPSULES - H.S. CODE: 96020030
EMPTY HPMC (VEGETARIAN) CAPSULES - H.S. CODE: 96020090
HEXAGON NUTRITION PRIVATE LIMITED.
Year of Establishment:
No. of manufacturing plants: 1
Details of Quality Accreditations: GMP & FSSAI
Product Category: Formulations
Company Profile:
We “Hexagon Nutrition” are proud to introduce ourselves as one of the leading names in
Nutritional Products (Excellence in Clinical Nutrition, Animal Nutrition and Food Fortification)
based on the principles of Total Quality Management (TQM) and Good Manufacturing Practices
(GMP). Since 1991, we are known for delivering innovations and reliable, unmatched services
and to both domestic and international markets in the Nutrition industry.With a presence in over
72 countries, “Hexagon Nutrition” is dedicated to offer world-class solutions for holistic
nutrition.Currently, Hexagon Nutrition has 3 state-of-the-art Manufacturing facilities in different
parts of India, conforming to International standards.
Product profile:
Pentasure, Geria Gold, Obesigo, Pentasure Hepatic, Pentasure Renal, Pentasure DLS,
Pentasure Critipep, Pentasure SPL, Pedia Gold, Pentasure 2.0, Pentasure Immunomax, Meta
Gluta ZS, Pentasure HP, Osteo Pro Forte, Eva Care – 21069099
Pentasure DM – 21069091
LEE PHARMA LIMITED
E-mail:
secmd@leepharma.com
Website:
www.leepharma.com
Year of Establishment:
Company Profile:
Lee Pharma Ltd is an Indian Pharmaceutical manufacturing company. Manufacturers of
Advanced Intermediate Chemicals, APIs & Semi finished formulations (Pellets & Granules).
Facility approvals Intermediate Chemicals & APIs - USFDA, EUGMP, Health Canada, KFDA.
Formulations-EUGMP, COFEPRIS cGMP-Mexico, KFDA. Chemical R&D Strength-50
scientists, Formulation R&D strength â27 scientists Patents Granted : Linezolid & its novel
intermediates US 9376407 B2 & EP 2595968 B1 Novel Oxazolidinone Antibacterial compound
US 9573910 B2 Filed : Linezolid Form II & Form III, Saxagliptin Intermediate, Lurasidone
Intermediate, Sitagliptin Phosphate Monohydrate.
Product Profile
Omeprazole API & Pellets (29333990), Lansoprazole API & Pellets (29333990), Pantoprazole
API & Pellets ( 29333990) , Esomeprazole API & Pellets (29333990), Dexlansoprazole API &
Pellets (29349900), Rabeprazole API & Pellets (29333990), Itraconazole API & Pellets
(29349900), Duloxetin Pellets (29349900), Fenofibrate Pellets, (29333990) , Orlistat Pellets
(29322090), Mebeverine Pellets (29221990) , Metoprolol Succinate Pellets (29181320) ,
Psuedophedrine Pellets (29394300) ,Diclofenac Sodium Pellets (29214490), Voriconazole API
(29335990), Olanzapine Form I & Form II (29349900), Sertraline Hcl (29214590), Lurasidone
API (29342000), Bilastine API, Varenicline Base(29339900), Varenicline Tartarate (29339900),
Dabigatran Etexilate Mesylate API & Pellets (29333990), Vildagliptin (29339900), Linagliptin
(29333990), Sitagliptin Phosphate Monohydrate (29333990), Tenelegliptin (29341000),
Tamsulosin API & Pellets(29094900), Lacosamide (29339900), Pregabalin (29159090)
MEHA CHEMICALS.
Year of Establishment:
No. of manufacturing plants: 1
Details of Quality Accreditations: WHO-GMP,
Product Category: API’s
Company Profile:
We Are A Who Gmp Certified Manufacturer Established In 2004 Of Antacid Range Of Bulk
Drugs In India. We Have Who Gmp, Indian Gmp, Iso 9001:2015 And Koscher Certifcation. We
Have A Very Strong Rnd And Can Customised Products To Cater To Customised
Requirements Of Particle Size, Bulk Density, Viscosities And Impurities. The Owner Handles
Rnd Himself And Has Post Graduate Degree In Chemcial Engineering From Usa. The
Company Exports To More Than 22 Countries Inclusing Australia, Usa And Mexico, Canada.
Product profile:
1. ALUMINIUM PHOSPHATE GEL 2. DRIED ALUMINIUM PHOSPHATE 3. ALMAGATE / HYDROTALCITE 4.
CALCIUM SILICATE 5. SIMETHICONE POWDERS 30%, 50%, 65% 6. SIMETHICONE 100% AND 30%
EMULSION 7. MAGALDRATE POWDER AND PASTE 8. MAGNESIUM HYDROXIDE POWDER AND PASTE 9.
MAGNESIUM TRISILICATE 10. MAGNESIUM SILICATE 11. ALUMINIUM HYDROXIDE POWDER
AND PASTE ,Direct Compressible products  Compound Magnesium Trisilicate BP 600 mg tab wt.
 Compound Magnesium Trisilicate BP Double strength 1150 mg tab weight  Dried Aluminium
Hydroxide Tablets 500 mg BP 1065 mg tab weight  Dried Aluminium Hydroxide(200 mg) +
Magnesium Hydroxide (200 mg) + simethicone (20 mg) 850 mg tab weight  Dried Aluminium
Hydroxide Gel 250mg+Magnesium Hydroxide 250mg+Simethicone 50 mg 1200 mg Tablet weight
METINA PHARMCONSULTING PVT LTD.
Year of Establishment:
No. of manufacturing plants: 11
Details of Quality Accreditations: WHO-GMP,USFDA,PICS,EU-GMP,
Product Category: Pharmaceuticals Regulatory and GMP
Services.
Company Profile:
"Metina is a pharmaceutical consulting firm having expertise in submissions and approvals for
USA, EU and Emerging Markets and expertise in filing & approval of ANDA, NDA, NCE as well
as Branded Generic Products across the globe. Metina currently offers consultancy services to
Pharmaceutical Industry and covers end to end regulatory and business development activity
covering strategy development, due diligence of dossier, in-license/out-license of dossiers,
Submission Management to Health Authorities, product market launch. It also offers
consultancy services for EU GMP approvals, API QP Audits to the manufacturing sites in India
and Worldwide.
Product profile:
1. ANDA SUBMISSIONS AND APPROVALS 2. DMF, ASMF,CEP 3. API QP AUDIT 4. MAH & MEDICINES
IMPORT IN EU 5. EU SUBMISSION AND APPROVAL 6. COMPETENCE & PERFORMANCE WITH EMERGING
AGENCIES 7. WHO PQP & ACCESS TO 35 EMERGING ECONOMIES 8. PRODUCT LIFECYCLE MANAGEMENT
9. BIOSIMILARS EXPERT ADVICE 10. GLOBAL DOSSIER DEVELOPMENT 11. REGULATORY INSIGHT AND
GUIDANCE 12. EU GMP SCHEDULING TO CERTIFICATION 13. PIC/S GMP INSPECTION 14. GLP & GCP
INSPECTIONS
ORGANIZATION NAME : Natura Biotechnol Pvt Ltd
Name (of the Rajesh Ramchandr
travelling delegate):
Designation:
City Bangalore
Mobile Number: 9833875404
E-mail: rt@naturabt.com
Website: www.naturabt.com
02
No. of manufacturing plants:
Year of Establishment:
Company Profile:
Nosch Labs is Manufacturer of Active Pharmaceutical Ingredients and Semi Finished
Formulation (Pellets) with cGMP, WHO GMP, EU GMP Certification based at Hyderabad.
Catering to various markets spread across the world since 2001.Nosch Labs is Manufacturer of
Active Pharmaceutical Ingredients and Semi Finished Formulation (Pellets) with cGMP, WHO
GMP, EU GMP Certification based at Hyderabad. Catering to various markets spread across
the world since 2001..
Product profile:
All the Products are supported by DMF in CTD format and especially hold CEP/COS for Lansoprazole,
Itraconazole, Pantoprazole, Duloxetine, Olanzapine, Quetiapine, Esomeprazole Magnesium Trihydrate
and Esomeprazole Magnesium Dihydrate.
Last but not the least we hold Dossier for Duloxetine Capsules and successfully obtained authorization in
Spain/ expect few other European Markets
SAGA LABORATORIES
Year of Establishment:
No. of manufacturing plants: 1
Details of Quality Accreditations: WHO-GMP,PICS,EU-GMP,TGA
Product Category: Formulation, Nutraceuticals
Company Profile:
Saga is an Indian company engaged in manufacture and marketing of finished pharmaceutical
formulations. It has manufacturing site approve by most respected and stringent regulatory
authorities including EU GMP , TGA Australia GMP and WHO GMP. The site can handle Oral
Solid Dosage forms - Tablets, Capsules, Oral Powders (Sachet) and Dry Syrups (bottles,
powder for reconstitution) Saga has expertise in Product (formulation) development, Quality
Assurance and Compliance (cGMP, QC and QMS) and Production excellence - bringing value
to partners. For Australia, we are looking for two kinds of partnerships- Offering our site as a
CMO through site transfer and in-licensing, Product Development and Co-development projects
and Offering our own dossiers. We can assure timely delivery and excellent compliance- a must
for partnering.
Product profile:
30043000
SIFLON DRUGS
Year of Establishment:
No. of manufacturing plants: 2
Details of Quality Accreditations: WHO-GMP,
Product Category: Formulation
Company Profile:
SIFLON DRUGS manufactures and exporters of veterinary API's worldwide we are exporting
more than 50 countries in regulatory and non-regulatory market
Product profile:
Oxyclozanide(HS Code:29420033), Rafoxanide( HS CODE:29280090) Closantel Base(HS
CODE:29280090 Closantel Sodium(HS CODE:29280090 Triclabendazole(HS
CODE:29339900 Niclosamide(HS CODE:29420090 Clorsulon (HS CODE:29420090
SUPRIYA LIFESCIENCE LTD.
Company Profile:
Supriya Lifescience Ltd is a 32 year old company excelling into pharmaceutical and
phytochemical API's.We are Pioneers in therapeutic segments like Anti-Histamine, Anti-Allergic,
Vitamins and Anti- Asthmatic.The company is Headquartered in Mumbai and has a State-of-
the-art US FDA and EU GMP certified facility in Khed, Ratnagiri spread across 20000 sqm. In a
dynamic and constantly changing industry and market, it is our ability to adapt, reinvent and
innovate that has kept us in the vanguard and has helped us achieve a CAGR of 22%.
Product profile:
Chlorpheniramine Maleate Brompheniramine Maleate Pheniramine Maleate
Dexchlorpheniramine Maleate Dexbrompheniramine Maleate Mepyramine Maleate / Pyrilamine
Maleate Cetirizine Di Hydrochloride Levocetirizine Di Hydrochloride Diphenhydramine
Hydrochloride Diphenhydramine Citrate Diphenhydramine Methyl Sulphate Salbutamol
Sulphate Levosalbutamol Sulphate Dextromethorphan Hydrobromide Phenylephrine
Hydrochloride Ketamine Hydrochloride Esketamine Hydrochloride Tramadol Hydrochloride
Lidocaine Lidocaine HCL Riboflavin 5 - Phosphate Sodium (Vitamin B 2 5 Phosphate Sodium)
Methylcobalamin Hydroxocobalamin Hydroxocobalamin Acetate Hydroxocobalamin
Hydrochloride Hydroxocobalamin sulphate Bupropion Hydrochloride Bisoprolol Fumarate
Nicorandil Artemether Lumefantrine Ractopamine Hydrochloride Theobromine Pentoxifylline
Colchicine Thio - Colchicoside
XL LABORATORIES PVT. LTD.
Plant I at Bhiwadi (Rajasthan) for the manufacturing of Tablets, Hard Gelatin Capsules, Oral
Liquids & Powder/Granules in Sachet. 2.
XL is present in over 30 countries with more than 400 product registrations encompassing over
45 therapeutic segments.
The manufacturing processes employ latest technological equipment with end to end
automation to minimize manual handling of materials and online instruments to assess critical
parameters and mitigate risk during manufacturing.
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. In house Regulatory Department at XL which works for
international filings and understands the needs of regulatory documentation of each country
thereby ensuring precise and accurate document submission.
We are offering manufacturing & contract development (analytical & formulation) services for
Tablets, Hard & Soft Gelatin Capsules, Oral Liquids and Powder/Granules in Sachet, dossier
development, validation batches and out licensing. In house Regulatory Department at XL which
works for international filings and understands the needs of regulatory documentation of each
country thereby ensuring precise and accurate document submission swiftly.
Product profile:
www.inzbc.org