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Page No- 1 PHARMACEUTICAL API PRODUCT LIST – MAY 2012 Sr. No Molecule Name Therapeutic Category Development Priority Lab Samples Validation Batches DMF ONCOLOGY PRODUCTS 1 TEMOZOLOMIDE* Antineoplastic Commercialized Ready Done Ready 2 CAPECITABINE Antineoplastic Commercialized Ready Done Ready 3 IMATINIB Antineoplastic Commercialized Ready Done Ready 4 PEMETREXED Antineoplastic Commercialized Ready Done Ready 5 ERLOTINIB Antineoplastic Commercialized Ready Done Ready 6 BORTEZOMIB Antineoplastic Commercialized Ready Done August 2012 STEROIDS 1 DUTASTERIDE BPH Product Commercialized Ready Done Ready 2 NANDROLONE DECANOATE Hormonal, Anabolic Steroid Commercialized Ready Done Ready 3 ROCURONIUM BROMIDE Muscle Relaxant Commercialized Ready Done Ready 4 LOTEPREDNOL Corticosteroid for Ophthalmic use Commercialized Ready Done Ready FERMENTATION PRODUCTS 1 HYALURONIC ACID Osteoarthritis, Ophthalmic use Commercialized Ready Done - OTHER PRODUCTS 1 ESZOPICLONE Sedative and Hypnotic Commercialized Ready Done Ready * Product only available for offer in markets other than North America, Australia, Japan. PHARMACEUTICAL API DEVELOPMENT LIST Sr. No Molecule Name Therapeutic Category Lab Samples ONCOLOGY PRODUCTS 1 LENALIDOMIDE Antineoplastic Ready 2 DECITABINE Antineoplastic Ready 3 SUNITINIB Antineoplastic August 2012 4 SORAFENIB Antineoplastic Ready 5 AZACITIDINE Antineoplastic Ready STEROIDS AND HORMONES 1 FULVESTRANT Estrogen Receptor Antagonist August 2012 PEPTIDES 1 LEUPROLIDE Prostate cancer or breast cancer, estrogen-dependent conditions Ready 2 GOSERELIN Hormone Sensitive Cancers August 2012 OTHER PRODUCTS 1 PARICALCITOL Vitamin D Analogue August 2012 The above products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Reliance Life Sciences Private Limited offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction. P. T. O

RLS Pharma API & FDF List - May 2012.pdf

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Page 1: RLS Pharma API & FDF List - May 2012.pdf

Page No- 1 PHARMACEUTICAL API PRODUCT LIST – MAY 2012

Sr. No

Molecule Name Therapeutic Category Development Priority

Lab Samples

Validation Batches

DMF

ONCOLOGY PRODUCTS

1 TEMOZOLOMIDE* Antineoplastic Commercialized Ready Done Ready

2 CAPECITABINE Antineoplastic Commercialized Ready Done Ready

3 IMATINIB Antineoplastic Commercialized Ready Done Ready

4 PEMETREXED Antineoplastic Commercialized Ready Done Ready

5 ERLOTINIB Antineoplastic Commercialized Ready Done Ready

6 BORTEZOMIB Antineoplastic Commercialized Ready Done August 2012

STEROIDS

1 DUTASTERIDE BPH Product Commercialized Ready Done Ready

2 NANDROLONE DECANOATE Hormonal, Anabolic Steroid Commercialized Ready Done Ready

3 ROCURONIUM BROMIDE Muscle Relaxant Commercialized Ready Done Ready

4 LOTEPREDNOL Corticosteroid for Ophthalmic use Commercialized Ready Done Ready

FERMENTATION PRODUCTS

1 HYALURONIC ACID Osteoarthritis, Ophthalmic use Commercialized Ready Done -

OTHER PRODUCTS

1 ESZOPICLONE Sedative and Hypnotic Commercialized Ready Done Ready

* Product only available for offer in markets other than North America, Australia, Japan.

PHARMACEUTICAL API DEVELOPMENT LIST

Sr. No Molecule Name Therapeutic Category Lab Samples

ONCOLOGY PRODUCTS

1 LENALIDOMIDE Antineoplastic Ready

2 DECITABINE Antineoplastic Ready

3 SUNITINIB Antineoplastic August 2012

4 SORAFENIB Antineoplastic Ready

5 AZACITIDINE Antineoplastic Ready

STEROIDS AND HORMONES

1 FULVESTRANT Estrogen Receptor Antagonist August 2012

PEPTIDES

1 LEUPROLIDE Prostate cancer or breast cancer, estrogen-dependent conditions

Ready

2 GOSERELIN Hormone Sensitive Cancers August 2012

OTHER PRODUCTS

1 PARICALCITOL Vitamin D Analogue August 2012

The above products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Reliance Life Sciences Private Limited offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction.

P. T. O

Page 2: RLS Pharma API & FDF List - May 2012.pdf

Page No- 2

PHARMACEUTICAL FINISHED DOSAGE FORMS DEVELOPMENT LIST – MAY 2012

Sr. No

Molecule Name Strength Dosage Form Therapeutic Category Dossier

ONCOLOGY PRODUCTS

1 CAPECITABINE 150 mg and 500 mg Tablet Antineoplastic November 2012

2 TEMOZOLOMIDE 5 mg, 20 mg, 100 mg, 140

mg, 180 mg and 250 mg Capsule Antineoplastic

November 2012

3 BORTEZOMIB 1 mg and 3.5 mg Vial Antineoplastic December 2012

4 PEMETREXED 100 mg and 500 mg Vial Antineoplastic January 2013

HORMONAL API PRODUCT LIST

Sr. No Molecule Name Therapeutic Category Development Priority

Lab Samples Validation Batches

HORMONES

1 ESTRADIOL Hormonal Developed Ready TBD

2 ESTRIOL Hormonal Developed Ready TBD

3 TESTOSTERONE Hormonal, Anabolic Steroid Developed Ready TBD

4 ESTRADIOL VALERATE Hormonal Developed Ready TBD

5 TESTOSTERONE CYPIONATE Hormonal, Anabolic Steroid Developed Ready TBD

6 DROSPIRENONE Pre Menstrual pain, Birth control Developed Ready TBD

7 DESOGESTREL Oral Contraceptive Developed Ready TBD

8 DYDROGESTERONE Hormonal Under Development TBD TBD

The above products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Reliance Life Sciences Private Limited offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction.